ZASOCITINIB for Psoriatic arthritis

Stratification factors

• Prior biologic use

Inclusion criteria

• {"criterion_text":"- 1. Informed Consent: The subject is willing and able to understand and fully comply with study procedures and requirements in the opinion of the investigator."}
• {"criterion_text":"- 10. Medications for PsA: If the subject is receiving other concurrent treatments, they must be at the following stable doses: oral corticosteroids (≤10 mg/day of prednisone equivalent), NSAIDs or paracetamol/acetaminophen or lowpotency opiates (only tramadol up to 300 mg/day or combination of acetaminophen and codeine or hydrocodone are permitted) at stable dose for ≥1 week prior to the Day 1 visit. Initiation of these treatments between screening and Day 1 is not permitted."}
• {"criterion_text":"- 11. Contraception and Breastfeeding: The subject meets the following birth control requirements: a. An individual with potential for pregnancy, who is now surgically sterile; OR b. A subject of nonchildbearing potential with laboratory confirmation of postmenopausal status; OR c. If sexually active with a nonsterilized individual who produces sperm, an individual with potential for pregnancy who agrees to use a highly effective method of contraception from the signing of the ICF throughout the duration of the study and for at least 10 days after the last dose of the trial intervention. The use of effective contraception is not required for subjects assigned male sex at birth during the duration of the study. Note: Oral hormonal contraception may be susceptible to interaction with zasocitinib, which may reduce the efficacy of the contraceptive method. Therefore, if subject is on a form of oral contraception, a second highly effective or effective method of contraception should be used during the entire study and for at least 10 days after the last dose of trial intervention. A barrier method is recommended, preferably a male external condom. Of note, an effective contraception method is only permitted in the case that hormonal contraception is used as the primary highly effective method of contraception."}
• {"criterion_text":"- 12. European Union (EU)/European Economic Area (EEA)-Specific : For subjects aged 65 years or older, the investigator must perform a benefit-risk assessment to justify the subject’s inclusion in the study."}
• {"criterion_text":"- 13. European Union (EU)/European Economic Area (EEA)-Specific: For subjects currently smoking/chewing tobacco or with a history of long-term smoking (≥20 pack years)/chewing tobacco use, the investigator must perform a benefit-risk assessment to justify the subject’s inclusion in the study."}
• {"criterion_text":"- 14. European Union (EU)/European Economic Area (EEA)-Specific : For subjects who elect to use hormonal contraception as a form of highly effective contraception, the investigator must perform a benefit-risk assessment to justify the subject’s inclusion in the study at screening."}
• {"criterion_text":"- 2. Informed Consent: The subject has provided informed consent (ie, in writing, documented via a signed and dated ICF) and any required privacy authorization before the initiation of any study procedures."}
• {"criterion_text":"- 3. Age: The subject is aged 18 years or older at the time of signing the ICF"}
• {"criterion_text":"- 4. Disease Characteristics: The subject has: a. A diagnosis of PsA, AND b. Signs and symptoms of PsA for at least 3 months prior to screening."}
• {"criterion_text":"- 5. Disease Characteristics: The subject meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria)."}
• {"criterion_text":"- 6. Disease Characteristics : The subject has active arthritis as shown by a minimum of ≥3 tender joints in TJC68 and ≥3 swollen joints in SJC66 at the screening and baseline (Day 1) visits."}
• {"criterion_text":"- 7. Disease Characteristics: The subject has at least 1 active lesion of plaque PsO ≥2 cm in diameter, or any nail or nail bed changes characteristic of PsO."}
• {"criterion_text":"- 8. Medications for PsA :The subject has had at least one of the following: a. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) after a minimum of 2 weeks of therapy (not applicable in EU/ EEA), OR b. Inadequate response to a conventional synthetic (cs)DMARDand/or commercial pharmaceutical product after a minimum of 12 consecutive weeks of therapy (at the maximally tolerated dose or up to dose defined in Inclusion Criterion 9), or intolerance to a csDMARD and/or commercial pharmaceutical product (defined as treatment-related AEs), OR c. Bio-IR: Inadequate response to up to 2 biologic DMARDs (up to 2 TNFi OR up to 2 IL-17 inhibitors) after a minimum of 12 consecutive weeks of therapy, or intolerance"}
• {"criterion_text":"- 9. Medications for PsA: If the subject is on concomitant csDMARDs at study entry, the subject must be on ≤2 csDMARDs for ≥12 weeks. The doses must be stable for ≥4 weeks prior to the Day 1 visit as follows: methotrexate (MTX) (≤25 mg/week; ≤16 mg/week for Japan sites only), sulfasalazine (SSZ) (≤3000 mg/day), leflunomide (LEF) (≤20 mg/day), and hydroxychloroquine (HCQ) (≤400 mg/day). The combination of MTX and LEF is not allowed. a. Subjects who need to discontinue csDMARDs prior to the Day 1 visit to comply with this inclusion criterion must follow the procedure specified below or at least 5 times the mean terminal elimination half-life of a drug: ≥8 weeks for LEF if no elimination procedure was followed, or adhere to an elimination procedure (ie, 11 days with cholestyramine, or 30 days washout with activated charcoal or per local label); ≥4 weeks for all others."}

Exclusion criteria

• {"criterion_text":"- 1. PsA and PsO:The subject has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia (prior history of reactive arthritis or axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthropathy, is permitted if there is documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if there is documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly)"}
• {"criterion_text":"- 18. Recent/Concurrent Infectious Disease: Other infectious diseases: The subject has a history of symptoms suggestive of systemic or invasive infection within 30 days prior to Day 1. The subject has history of bacterial, viral, or fungal infection that required hospitalization or treatment with intravenous antimicrobial therapy within 8 weeks prior to Day 1 or oral antimicrobial therapy within 30 days prior to Day 1. The subject has a history of chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations/infections or fungal infections (except superficial onychomycosis). The subject has a history of an infected joint prosthesis or has received antibiotics for a suspected infection of a joint prosthesis, unless that prosthesis has been removed or replaced at least 60 days prior to Day 1. The subject has a history of opportunistic infections (eg, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis). The subject had a bacterial infection within 60 days prior to Day 1 for which they did not receive treatment."}
• {"criterion_text":"- 19. Noninfectious Disorders : The subject has any clinically significant medical condition, evidence of an unstable clinical condition (eg, cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or immunologic), or vital signs/physical/laboratory/electrocardiogram (ECG) abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results. These include but are not limited to: The subject has a history of known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy. The subject had a major surgery within 60 days prior to Day 1 or has a major surgery planned during the study. The subject has moderate or severe hepatic impairment per ChildPugh classification (Class B and C). The subject has uncontrolled hypertension characterized by systolic blood pressure >160mm Hg or diastolic blood pressure >100 mm Hg at screening, confirmed by 2 repeat assessments. The subject has a history of Class III or IV congestive heart failure as defined by New York Heart Association criteria. The subject has a history of cancer or lymphoproliferative disease, with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix, under the condition that the investigator performs a benefit-risk assessment. For subjects with asthma, chronic obstructive pulmonary disease, or other pulmonary illnesses, the subject has been hospitalized in the past 3 months, has ever required intubation for treatment, currently requires oral corticosteroids treatment, or has required more than 1 course of oral corticosteroids within 6 months prior to Day 1. The subject has any of the following cardiovascular disease history: A new diagnosis of atrial fibrillation or an episode of atrial fibrillation with rapid ventricular response or other dysrhythmia, non-acute cardiac hospitalization (eg, pacemaker implantation), pulmonary embolism, or deep venous thrombosis within the past 6 months prior to screening. Cerebrovascular event, myocardial infarction, coronary stenting, or aorto-coronary bypass surgery within the last 6 months. A subject may enroll if it has been at least 6 months since the occurrence of any such event and the subject is considered clinically stable by the investigator; in the EU/EEA, the investigators should perform a benefit-risk assessment. The subject has ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the subject if they participated in the study, in the opinion of the investigator. The subject has any lifetime history of suicide attempts, suicidal behavior, or active suicidal ideationwith intent and plan based on medical history or a YES response to C-SSRS Questions 5; the subject has evidence of current active suicidal ideation based on Yes response to Questions 2, 3, 4, or 5 on C-SSRS-SLV performed at the screening visit; or is clinically deemed to have a suicide risk by the investigator Per medical judgement, the subject has a known history of clinically significant drug or alcohol abuse, excluding stable medical or legal recreational marijuana/tetrahydrocannabinol/cannabidiol use, within 12 months of the screening visit."}
• {"criterion_text":"- 2. PsA and PsO: The subject has a history of excessive sun exposure, has used tanning booths within 4 weeks prior to Day 1, or is not willing to minimize natural and artificial sunlight exposure during the study period. Use of sunscreen products and protective apparel is recommended when sun exposure cannot be avoided."}
• {"criterion_text":"- 20. Other Prohibited Concomitant Medications: The subject has received lithium or intramuscular gold therapy within 4 weeks prior to Day 1."}
• {"criterion_text":"- 21. Other Prohibited Concomitant Medications: The subject is currently being treated with systemic strong or moderate cytochrome P450 (CYP)3A4 inhibitors (such as itraconazole or clarithromycin) or systemic strong or moderate CYP3A4 inducers (such as rifampin, carbamazepine, or phenytoin), or has received systemic strong or moderate CYP3A4 inhibitors or systemic strong or moderate CYP3A4 inducers within 4 weeks or 5 half-lives of the inducer or inhibitor, whichever is longer, prior to Day 1, or is expected to require treatment with systemic strong or moderate CYP3A4 inducers or inhibitors during the trial period."}
• {"criterion_text":"- 22. Other Prohibited Concomitant Medications: Other Prohibited Concomitant Medications: The subject has received any live-attenuated vaccine within 60 days prior to Day 1 or plans to receive a liveattenuated vaccine during the study and up to 4 weeks after the last trial intervention administration. Note: Non–live-attenuated vaccines or boosters for coronavirus disease 2019 (COVID-19) (eg, RNA-based vaccines, inactivated adenovirus-based vaccines, influenza vaccines, protein-based vaccines) are permitted during the study. The study site should follow local COVID-19 guidelines."}
• {"criterion_text":"- 23. Other Prohibited Concomitant Medications: The subject received a marketed or investigational biological agent (other than those for the treatment of PsA or PsO) within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1."}
• {"criterion_text":"- 24. Other Prohibited Concomitant Medications:The subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1."}
• {"criterion_text":"- 26. Other Prohibited Concomitant Medications: The subject is currently enrolled in a clinical trial or anticipates enrollment in a clinical trial during the course of the study."}
• {"criterion_text":"- 27. Laboratory/Physical: The subject has any of the following laboratory values at the screening visit: Aspartate aminotransferase or alanine aminotransferase values ˃3 × upper limit of normal (ULN). Total bilirubin (unconjugated and/or conjugated) ˃1.5 × ULN. Hemoglobin <9.0 g/dL (<90.0 g/L). Absolute white blood cell count <3.0 × 109/L (<3000/mm3). Absolute neutrophil count of <1.0 × 109/L (<1000/mm3). Absolute lymphocyte count of <0.5 × 109/L (<500/mm3). Platelet count <100 × 109/L (<100,000/mm3). Estimated creatinine clearance <45 mL/min based on the Cockcroft-Gault calculation. Creatine phosphokinase (CPK) > ULN. CPK may be repeated once; if repeat value is Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or lower (≤2.5 × ULN) and no higher than the initial value, subject remains eligible. Investigators should assess the subject for modulating factors including concomitant medications or vigorous exercise that may affect CPK level. The subject has any other significant laboratory abnormalities that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study."}
• {"criterion_text":"- 10. Prohibited PsA/PsO Treatment: The subject has used any topical medication that could affect PsA or PsO presentation, including but not limited to: corticosteroids, salicylic acid, roflumilast, urea, alpha- or beta-hydroxy acids, anthralin, retinoids, vitamin D analogues (such as calcipotriol), tazarotene, methoxsalen, trimethylpsoralen, pimecrolimus, tacrolimus, tapinarof, or tar within 2 weeks prior to Day 1; with the exception of low-potency topical steroids (World Health Organization Class VI and VII) on the palms, soles, face, intertriginous areas, and/or genitals and/or bland emollients on all body regions."}
• {"criterion_text":"- 11. Prohibited PsA/PsO Treatment:The subject has used any other nonbiologic treatment that could affect PsA or PsO presentation (including, intravenous, intramuscular, intra-articular, intrathecal, epidural, or intralesional corticosteroids; oral retinoids; immunosuppressive/immunomodulating medication; 6-thioguanidine; mercaptopurine; mycophenolate mofetil; hydroxyurea; cyclosporine; roflumilast; psoralens; fumaric acid derivatives) within 4 weeks prior to Day 1, or 5 half-lives, whichever is longer. Note: Intranasal corticosteroids, inhaled corticosteroids, and eye and ear drops containing corticosteroids are permitted."}
• {"criterion_text":"- 12. Prohibited PsA/PsO Treatment: The subject has received phototherapy (including UV B, psoralen and UV A, tanning beds, therapeutic sunbathing) or excimer laser to treat skin conditions within 4 weeks prior to Day 1."}
• {"criterion_text":"- 13. Prohibited PsA/PsO Treatment: The subject has used botanical preparations (eg, herbal or homeopathic supplements or traditional medicines, including traditional Chinese medicines derived from plants, minerals, or animals) intended to treat PsA, PsO, or other immunological diseases within 4 weeks prior to Day 1."}
• {"criterion_text":"- 14. Recent/Concurrent Infectious Disease: The subject has a history of active infection or febrile illness with or without symptoms (including but not limited to coryza and pharyngitis) within10 days prior to Day 1, as assessed by the investigator."}
• {"criterion_text":"- 15. Recent/Concurrent Infectious Disease: Tuberculosis (TB): a. The subject has a history of active TB infection, regardless of treatment status. b. The subject has signs or symptoms of active TB (including but not limited to chronic fever, chronic productive cough, night sweats, or weight loss) as judged by the investigator. c. The subject has evidence of a latent TB infection as evidenced by a positive QuantiFERON (QFT)-TB Gold result OR 2 indeterminate QFT interferon-gamma release assay (IGRA) results. The subject may remain eligible if: (1) there are no signs/symptoms of active TB and documentation of no prior history of active TB can be provided and (2) subject can provide documentation of prior completed treatment for latent TB infection (LTBI) (appropriate in duration and type per current local country guidelines) OR is willing to initiate LTBI prophylaxis (appropriate in duration and type per current local guidelines) a minimum of 2 weeks prior to Day 1. • In the EU/EEA, participants with evidence of LTBI, regardless of prophylaxis treatment status, must receive approval to participate in the trial from an infectious disease or other TB specialist (eg, pulmonologist). Note: TB prophylaxis regimens should be administered according to local guidelines; however, because of potential interactions with zasocitinib, rifampin should not be used. TB testing should be conducted using QFT submitted to the central laboratory unless alternate or additional tests are required per local guidelines. d. The subject has had any imaging study during or 6 months prior to screening, including x-ray, chest computed tomography, magnetic resonance imaging, or other chest imaging suggesting evidence of current active or a history of active TB. X-ray is required for all subjects regardless of QFT results unless the subject has had normal chest imaging in the 6 months prior to screening."}
• {"criterion_text":"- 16. Recent/Concurrent Infectious Disease: Herpes infections: The subject has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and/or medical history), at screening or Day 1. The subject has a history of serious herpetic infection that includes any episode of disseminated disease, multidermatomal herpes zoster, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (defined as 2 episodes within 2 years)."}
• {"criterion_text":"- 17. Recent/Concurrent Infectious Disease: Nonherpetic viral diseases: a. The subject has presence of hepatitis C virus (HCV) antibody and a positive confirmatory test result for HCV RNA (nucleic acid test or polymerase chain reaction [PCR]). b. The subject has presence of positive hepatitis B virus surface antigen (HBsAg+), indeterminate hepatitis B surface antigen, or positive antihepatitis B core antibody (HBcAb+). Subjects with an isolated HBsAb+ may enrollmedical record documentation of hepatitis B virus (HBV) vaccinationis recommended but not required. c. The subject has a history of positive results for human immunodeficiency virus (HIV) by serology, regardless of viral load. d. Additional monitoring guidelines for nonherpetic viral disease may be applicable per local guidelines."}
• {"criterion_text":"- 25. Other Prohibited Concomitant Medications: The subject has had exposure to the following PsA medications prior to Day 1 without appropriate washout: apremilast commercial pharmaceutical product, rituximab or other immune cell–depleting agents, agents that modulate integrin pathways to impact lymphocyte trafficking, agents that modulate B cells or T cells, TNFi or biosimilars, and IL-17 inhibitors."}
• {"criterion_text":"- 26. Other Prohibited Concomitant Medications: The subject is compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness, or is committed to an institution (eg, prison) by virtue of an order issued either by judicial or administrative authorities."}
• {"criterion_text":"- 27. Laboratory/Physical:The subject does not tolerate venipuncture or inability to be venipunctured"}
• {"criterion_text":"- 29. Allergies and Adverse Drug Reactions: The subject has a history of significant drug allergy (such as anaphylaxis)."}
• {"criterion_text":"- 30. Allergies and Adverse Drug Reactions: The subject has a known or suspected allergy to zasocitinib or any of its components."}
• {"criterion_text":"- 3. PsA and PsO: The subject has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO)."}
• {"criterion_text":"- 31. Other Exclusion Criteria: The subject has a positive pregnancy test result or plans to become pregnant during the study period, or subject is pregnant or lactating/nursing."}
• {"criterion_text":"- 32. Other Exclusion Criteria: The subject has given greater than 500 mL of blood or plasma within 30 days of screening (during a clinical trial or at a blood bank donation) or plans to donate blood during the course of the study."}
• {"criterion_text":"- 33. Other Exclusion Criteria: The subject is compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness, or is committed to an institution (eg, prison) by virtue of an order issued either by judicial or administrative authorities."}
• {"criterion_text":"- 34. Other Exclusion Criteria: The subject is a study site employee, an immediate family member (eg, spouse, parent, child, sibling), or is in a dependent relationship with study site employee who is involved in the conduct of the study or may consent under duress."}
• {"criterion_text":"- 4. Prohibited PsA/PsO Treatment: The subject had an inadequate response after a minimum of 12 consecutive weeks of therapy to > 2 TNFi OR > 2 IL-17 inhibitors."}
• {"criterion_text":"- 5. Prohibited PsA/PsO Treatment: The subject had inadequate response to more than 1 biologic DMARD class (eg, TNFi, IL-17 inhibitors)."}
• {"criterion_text":"- 6. Prohibited PsA/PsO Treatment: The subject had any prior exposure to IL-23 or IL-12/23 inhibitors."}
• {"criterion_text":"- 7. Prohibited PsA/PsO Treatment: The subject is receiving current treatment with >2 csDMARDs or use of csDMARDs other than MTX, SSZ, LEF, and HCQ or use of MTX in combination with LEF."}
• {"criterion_text":"- 8. Prohibited PsA/PsO Treatment:The subject had any prior exposure to any TYK2 inhibitor (eg, deucravacitinib, VTX958, or GLPG3367) or oral Janus kinase inhibitors (eg, upadacitinib, baricitinib, or tofacitinib)"}
• {"criterion_text":"- 9. Prohibited PsA/PsO Treatment: The subject has used medicated shampoo and/or body wash that includes but is not limited to salicylic acid, corticosteroids, coal tar, or vitamin D3 analogues within 2 weeks prior to Day 1."}

Primary endpoints

• {"endpoint_text":"- ACR20 response: Assessed as proportion of subjects achieving ACR20 at Week 16.","definition_or_measurement_approach":"Assessed as proportion of subjects achieving ACR20 at Week 16."}

Secondary endpoints

• {"endpoint_text":"- Key Secondary End Points_1_Zasocitinib Dose A vs. Placebo •\tMinimal disease activity (MDA): Assessed as proportion of subjects achieving MDA status at Week 16. •\tPsoriasis Area and Severity Index (PASI)75 response (in subjects with a baseline ≥3% body surface area [BSA]): Assessed as proportion of subjects achieving ≥75% improvement from baseline in PASI score at Week 16.","definition_or_measurement_approach":"Proportion achieving MDA at Week 16; proportion achieving ≥75% improvement in PASI (PASI75) at Week 16 in subjects with baseline ≥3% BSA."}
• {"endpoint_text":"- Key Secondary End Points_1_Cont... •\tACR50 response: Assessed as proportion of subjects achieving ACR50 at Week 16. •\tChange from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) score at Week 16. •\tACR70 response: Assessed as proportion of subjects achieving ACR70 at Week 16.","definition_or_measurement_approach":"Proportion achieving ACR50 and ACR70 at Week 16; change from baseline in HAQ-DI at Week 16."}
• {"endpoint_text":"- Key Secondary End Points_1_Cont... •\tChange from baseline in the Short Form Survey-36 item (SF-36) v2.0 physical component summary (PCS) score at Week 16. •\tChange from baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score at Week 16.","definition_or_measurement_approach":"Change from baseline in SF-36 v2.0 PCS and FACIT-Fatigue at Week 16."}
• {"endpoint_text":"- Key Secondary End Points_2_Zasocitinib Dose B vs. Placebo •\tMDA: Assessed as proportion of subjects achieving MDA status at Week 16. •\tACR50 response: Assessed as proportion of subjects achieving ACR50 at Week 16.","definition_or_measurement_approach":"Proportion achieving MDA and ACR50 at Week 16 for Dose B vs placebo."}
• {"endpoint_text":"- Key Secondary End Points_2_Cont...•\tChange from baseline in the HAQ-DI score at Week 16. •\tACR70 response: Assessed as proportion of subjects achieving ACR70 at Week 16. •\tPASI75 response (in subjects with a baseline ≥3% BSA): Assessed as proportion of subjects achieving ≥75% improvement from baseline in PASI score at Week 16.","definition_or_measurement_approach":"Change in HAQ-DI; proportion ACR70; PASI75 at Week 16."}
• {"endpoint_text":"- Secondary End Points_1_ Zasocitinib Dose A vs. Placebo Zasocitinib Dose B vs. Placebo •\tEnthesitis resolution in subjects with enthesitis at baseline (Leeds Enthesitis Index [LEI]>0): Assessed as proportion of subjects meeting LEI=0 at Week 16. •\tChange from baseline in individual components of ACR response at Week 16.","definition_or_measurement_approach":"Proportion with LEI=0 at Week16; change in ACR component measures at Week16."}
• {"endpoint_text":"- Secondary End Points_1_ Cont... •\t •\tDactylitis resolution in subjects with dactylitis (Leeds Dactylitis Index [LDI] Basic >0) at baseline: Assessed as proportion of subjects meeting LDI Basic=0 at Week 16. •\tPASI75 response (in subjects with ≥3% BSA at baseline) at Week 4. •\tPASI75 response (in subjects with ≥3% BSA at baseline) at Week 8.","definition_or_measurement_approach":"Proportion with LDI Basic=0 at Week16; PASI75 proportions at Weeks 4 and 8 in subjects with baseline ≥3% BSA."}
• {"endpoint_text":"- Secondary End Points_1_ Cont... •\tPASI90 response (in subjects with ≥3% BSA at baseline) at Week 16. •\tPASI100 response (in subjects with ≥3% BSA at baseline) at Week 16. •\tACR50 and PASI100 response (in subjects with ≥3% BSA at baseline): Assessed as proportion of subjects simultaneously achieving ACR50 and PASI100 at Week 16.","definition_or_measurement_approach":"PASI90 and PASI100 proportions at Week16; combined ACR50+PASI100 proportion at Week16."}
• {"endpoint_text":"- Secondary End Points_1_ Cont... •\tStatic physician’s global assessment (sPGA) 0/1 response (in subjects with baseline sPGA ≥2): Assessed as proportion of subjects achieving an sPGA of clear (0) or almost clear (1) with a ≥2-point decrease from baseline at Week 16.","definition_or_measurement_approach":"Proportion achieving sPGA 0/1 with ≥2-point decrease at Week16 in subjects with baseline sPGA ≥2."}
• {"endpoint_text":"- Secondary End Points_1_ Cont...•\tHAQ-DI response: Assessed as proportion of HAQ-DI minimal clinically important differences responders (defined as achieving a clinically meaningful reduction of ≥0.35 from baseline) at Week 16.","definition_or_measurement_approach":"Proportion of subjects with HAQ-DI reduction ≥0.35 from baseline at Week16."}
• {"endpoint_text":"- Secondary End Points_1_ Cont...•\tChange from baseline in the SF-36 v2.0 mental component summary score at Week 16. •\tChange from baseline in Psoriatic Arthritis Impact of Disease-12 items total score at Week 16.","definition_or_measurement_approach":"Change from baseline in SF-36 v2.0 mental component and in PsA Impact of Disease-12 total score at Week16."}
• {"endpoint_text":"- Secondary End Points_1_ Cont...•\tChange from baseline in Disease Activity Index for Psoriatic Arthritis score at Week 16. •\tChange from baseline in Disease Activity Score-28[C-reactive protein] score at Week 16. •\tChange from baseline in physician’s global assessment of fingernail psoriasis (PGA-F) score in subjects with psoriatic nail involvement (PGA-F>0) at baseline at Week 16.","definition_or_measurement_approach":"Change from baseline in Disease Activity Index for PsA, DAS28(CRP), and PGA-F at Week16."}
• {"endpoint_text":"- Secondary End Points_2_Zasocitinib Dose B vs. Placebo •\tChange from baseline in the SF-36 v2.0 PCS score at Week 16. •\tChange from baseline in the FACIT Fatigue score at Week 16.","definition_or_measurement_approach":"Change from baseline in SF-36 v2.0 PCS and FACIT-Fatigue at Week16 for Dose B vs placebo."}
• {"endpoint_text":"- Secondary End Points_1_Continued_ • Enthesitis resolution in subjects with enthesitis (SPARCC Enthesitis Index >0) at baseline: Assessed as proportion of subjects meeting SPARCC Enthesitis Index=0 through Week 16. • ACR20 response: Assessed as proportion of subjects achieving ACR20 at Week 8.","definition_or_measurement_approach":"Proportion achieving SPARCC Enthesitis Index=0 through Week16; proportion achieving ACR20 at Week8."}

Methods

• Digital advertising: digital ads, search ads, social media video scripts and social media packets (materials available in Spanish, French, German, Polish and English) targeting potential participants with PsA.
• Landing page and online prescreener: dedicated landing pages and prescreener tools to identify eligible participants (country-specific landing pages and copies available).
• Doctor-to-doctor and doctor-to-patient emails: materials for HCP outreach to refer patients (country-specific materials for France, Germany, Spain, Poland).
• Patient messaging and advocacy messaging: patient messaging packets and advocacy emails/messages prepared (country/language-specific).
• Print materials and broadcast: recruitment brochures, flyers, posters, print ads and radio scripts for local promotion.
• KIK / StudyKIK materials and quick reference cards: onboarding and site-facing recruitment materials.
• Master screener and prescreener tools and scripts (site-based telephone/workshop scripts) to screen potential participants.
• Third-party patient recruitment vendors named in sponsor documents (e.g., Caerus Marketing Group LLC, Clinical Trial Media Inc.) supporting recruitment activities.

Spain

Earliest CTIS Part Ii Submission Date

03-04-2025

Latest Decision Or Authorization Date

27-10-2025

Processing Time Days

207

Number Of Sites

6

Number Of Participants

24

France

Earliest CTIS Part Ii Submission Date

03-03-2025

Latest Decision Or Authorization Date

27-10-2025

Processing Time Days

238

Number Of Sites

5

Number Of Participants

9

Germany

Earliest CTIS Part Ii Submission Date

15-04-2025

Latest Decision Or Authorization Date

12-11-2025

Processing Time Days

211

Number Of Sites

5

Number Of Participants

28

Poland

Earliest CTIS Part Ii Submission Date

15-04-2025

Latest Decision Or Authorization Date

13-03-2026

Processing Time Days

332

Number Of Sites

11

Number Of Participants

133

Primary sponsor

Full Name

Takeda Development Center Americas Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Development LP

Responsibilities

sponsorDuties codes: 1,13,5,6; contact EUCTRInquiry.sm@ppd.com

Name

Suvoda LLC

Responsibilities

sponsorDuties code: 3; e.g., IRT/operational support (as listed)

Name

QPS LLC

Responsibilities

sponsorDuties codes include 15 (medical imaging central read) and 4 (laboratory/operational support)

Third parties

• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: 1,13,5,6; contact EUCTRInquiry.sm@ppd.com","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"Medical Imaging - X-ray and central read (code 15) and code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"sponsorDuties code: 7 (electronic data capture / patient-facing systems); contact TAK-279-PsA-3002@signanthealth.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eurofins Viracor Biopharma Services LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Data Monitoring Committee (code 15; value: Data Monitoring Committee)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Optional Medical Photography (code 15) and related support","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Caerus Marketing Group LLC","duties_or_roles":"Patient Recruitment (code 15; value: Patient Recruitment)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Medical Imaging - X-ray and central read (code 15)","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Cellcarta Biosciences Inc.","duties_or_roles":"Medical Imaging - X-ray and central read (code 15) and code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Reimbursement and Stipend (code 15)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"Medical Imaging - X-ray and central read and laboratory support (codes 15 and 4)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"Patient Recruitment (code 15)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"QPS LLC","duties_or_roles":"Medical Imaging - X-ray and central read (code 15) and code 4","organisation_type":"Pharmaceutical company"}