zasocitinib for Psoriatic arthritis

Inclusion criteria

• {"criterion_text":"- The subject is willing and able to understand and fully comply with study procedures and requirements in the opinion of the investigator.\n- 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 low-potency 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.\n- 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.\n- For subjects aged 65 years or older, the investigator must perform a benefit-risk assessment to justify the subject’s inclusion in the study.\n- 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.\n- 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.\n- 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.\n- The subject is aged 18 years or older at the time of signing the ICF. In South Korea, the age requirement for adult subjects is ≥19 years of age.\n- The subject has a) A diagnosis of PsA, AND B) Signs and symptoms of PsA for at least 3 months prior to screening.\n- The subject meets the CASPAR criteria.\n- 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.\n- 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.\n- The subject has had at least one of the following: a) Inadequate response to an NSAID after a minimum of 2 weeks of therapy (not applicable in the EU/EEA), OR b) Inadequate response to a csDMARD 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 (defined as treatment-related AEs).\n- 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: MTX (≤25 mg/week), SSZ (≤3000 mg/day), LEF (≤20 mg/day), and 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":"- 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 nonradiographic axial spondyloarthritis, 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).\n- The subject has received lithium or intramuscular gold therapy within 4 weeks prior to Day 1.\n- The subject is currently being treated with systemic strong or moderate CYP3A4 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.\n- 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.\n- The subject has received any live-attenuated vaccine within 60 days prior to Day 1 or plans to receive a live-attenuated vaccine during the study and up to 4 weeks after the last trial intervention administration. Note: Non–live-attenuated vaccines or boosters for 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.\n- 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\n- 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.\n- The subject is currently enrolled in a clinical trial or anticipates enrollment in a clinical trial during the course of the study.\n- The subject has any of the following laboratory values at the screening visit: a) AST or ALT values ˃3 × ULN. b) TBili (unconjugated and/or conjugated) ˃1.5 × ULN. c) Hemoglobin <9.0 g/dL (<90.0 g/L). d) Absolute white blood cell count <3.0 × 109/L (<3000/mm3). e) Absolute neutrophil count of <1.0 × 109/L (<1000/mm3). f) Absolute lymphocyte count of <0.5 × 109/L (<500/mm3). g) Platelet count <100 × 109/L (<100,000/mm3). h) Estimated creatinine clearance <45 mL/min based on the Cockcroft-Gault calculation. i) CPK > ULN. CPK may be repeated once; if repeat value is 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. j) 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.\n- The subject does not tolerate venipuncture or inability to be venipunctured.\n- The subject has a history of significant drug allergy (such as anaphylaxis).\n- 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.\n- The subject has contraindications listed in the country-specific label for active comparator.\n- The subject has a known or suspected allergy to zasocitinib, active comparator, or any of their components\n- The subject has a positive pregnancy test result or plans to become pregnant during the study period, or subject is pregnant or lactating/nursing.\n- 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).\n- 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.\n- 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.\n- 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.\n- The subject has received any of the following treatments: a) A biologic that is used for treatment of PsA or PsO (eg, TNFi [eg, etanercept, adalimumab, infliximab, certolizumab pegol, golimumab]; IL-12/23, IL-17, or IL-23 inhibitors [eg, ustekinumab, secukinumab, bimekizumab, brodalumab, ixekizumab, guselkumab, tildrakizumab, or risankizumab]). b) Any TYK2 inhibitor (eg, deucravacitinib, VTX958, or GLPG3367) or oral JAK inhibitor (eg, upadacitinib, baricitinib, or tofacitinib). c) Rituximab or other immune cell-depleting agents within 6 months prior to Day 1. d) Agents that modulate integrin pathways to impact lymphocyte trafficking (eg, natalizumab) or agents that modulate B cells or T cells (eg, alemtuzumab, visilizumab, or abatacept) within 3 months prior to Day 1.\n- 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.\n- 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.\n- 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.\n- 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 betahydroxy 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 (WHO Class VI and VII) on the palms, soles, face, intertriginous areas, and/or genitals and/or bland emollients on all body regions\n- 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.\n- The subject has a history of active infection or febrile illness with or without symptoms (including but not limited to coryza and pharyngitis) within 10 days prior to Day 1, as assessed by the investigator.\n- 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 QFT-TB Gold result OR 2 indeterminate QFT 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 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 and active comparator, 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 CT, MRI, 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.\n- Herpes infections: a) 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. b) 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).\n- Nonherpetic viral diseases: a) The subject has presence of HCV antibody and a positive confirmatory test result forHCV RNA (nucleic acid test or polymerase chain reaction). b) The subject has presence of positive hepatitis B virus surface antigen (HBsAg+), indeterminate hepatitis B surface antigen, or positive anti-hepatitis B core antibody (HBcAb+). Subjects with an isolated positive anti-hepatitis B surface antibody (HBsAb+) may enroll; medical record documentation of HBV vaccination is recommended but not required. c) The subject has a history of positive results for HIV by serology, regardless of viral load. d) Additional monitoring guidelines for nonherpetic viral diseases may be applicable per local guidelines.\n- Other infectious diseases: a) The subject has a history of symptoms suggestive of systemic or invasive infection within 30 days prior to Day 1. b) 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. c) 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). d) 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. e) The subject has a history of opportunistic infections (eg, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis). f) The subject had a bacterial infection within 60 days prior to Day 1 for which they did not receive treatment.\n- 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/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: a) 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. b) The subject had a major surgery within 60 days prior to Day 1 or has a major surgery planned during the study. c) The subject has moderate or severe hepatic impairment per Child-Pugh classification (Class B and C). d) The subject has uncontrolled hypertension characterized by systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg at screening, confirmed by 2 repeat assessments. e) The subject has a history of Class III or IV congestive heart failure as defined by New York Heart Association criteria. f) 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. g) 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. h) 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. i) 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. j) The subject has any lifetime history of suicide attempts, suicidal behavior, or active suicidal ideation with 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. k) 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."}

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 (ACR20 = American College of Rheumatology 20% improvement criteria)."}

Secondary endpoints

• {"endpoint_text":"- 1. Key Secondary endpoint : Zasocitinib Dose A vs. Placebo • MDA: Assessed as proportion of subjects achieving MDA status at Week 16. • PASI75 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":"MDA: proportion achieving minimal disease activity at Week 16. PASI75: proportion with ≥75% improvement from baseline in PASI at Week 16 (in subjects with baseline BSA ≥3%)."}
• {"endpoint_text":"- 2. Key Secondary endpoint: ACR50 response: Assessed as proportion of subjects achieving ACR50 at Week 16. • Change from baseline in the HAQ-DI score at Week 16. • ACR70 response: Assessed as proportion of subjects achieving ACR70 at Week 16.","definition_or_measurement_approach":"ACR50/ACR70: proportions achieving 50% or 70% ACR improvement at Week 16. HAQ-DI: change from baseline in Health Assessment Questionnaire-Disability Index at Week 16."}
• {"endpoint_text":"- 3. Key Secondary endpoint: Change from baseline in the SF-36 v2.0 PCS score at Week 16. • Change from baseline in the FACIT-Fatigue score at Week 16.","definition_or_measurement_approach":"Change from baseline in SF-36 v2.0 Physical Component Summary (PCS) and FACIT-Fatigue scores at Week 16."}
• {"endpoint_text":"- 4. Key Secondary endpoint: Zasocitinib Dose B vs. Placebo • MDA: Assessed as proportion of subjects achieving MDA status at Week 16. • ACR50 response: Assessed as proportion of subjects achieving ACR50 at Week 16.","definition_or_measurement_approach":"MDA and ACR50 assessed as proportions at Week 16."}
• {"endpoint_text":"- 5. Key Secondary endpoint: Change from baseline in the HAQ-DI score at Week 16. • ACR70 response: Assessed as proportion of subjects achieving ACR70 at Week 16.","definition_or_measurement_approach":"HAQ-DI change from baseline and ACR70 proportion at Week 16."}
• {"endpoint_text":"- 6. Key Secondary endpoint: PASI75 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":"PASI75 proportion at Week 16 in subjects with baseline BSA ≥3%."}
• {"endpoint_text":"- 7. Key Secondary endpoint: Zasocitinib Dose A vs. active comparator • ACR20 response: Assessed as proportion of subjects achieving ACR20 at Week 16. • PASI75 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":"ACR20 and PASI75 proportions at Week 16 (for Dose A vs active comparator)."}
• {"endpoint_text":"- 8. Key Secondary endpoint: Zasocitinib Dose B vs. active comparator • ACR20 response: Assessed as proportion of subjects achieving ACR20 at Week 16.","definition_or_measurement_approach":"ACR20 proportion at Week 16 (Dose B vs active comparator)."}
• {"endpoint_text":"- 9. 1. Zasocitinib Dose A vs. Placebo Zasocitinib Dose B vs. Placebo • Enthesitis resolution in subjects with enthesitis at baseline (LEI >0): Assessed as proportion of subjects meeting LEI=0 at Week 16. • Change from baseline in individual components of ACR response at Week 16.","definition_or_measurement_approach":"Enthesitis resolution: proportion with LEI=0 at Week 16. Individual ACR components: change from baseline at Week 16."}
• {"endpoint_text":"- 10. 2. • Dactylitis resolution in subjects with dactylitis (LDI Basic >0) at baseline: Assessed as proportion of subjects meeting LDI Basic=0 at Week 16. • PASI75 response (in subjects with ≥3% BSA at baseline) at Week 4. • PASI75 response (in subjects with ≥3% BSA at baseline) at Week 8.","definition_or_measurement_approach":"Dactylitis resolution: proportion with LDI Basic=0 at Week 16. PASI75 at Weeks 4 and 8 for subjects with baseline BSA ≥3%."}
• {"endpoint_text":"- 11. 3. PASI90 response (in subjects with ≥3% BSA at baseline) at Week 16. • PASI100 response (in subjects with ≥3% BSA at baseline) at Week 16.","definition_or_measurement_approach":"PASI90 and PASI100 proportions at Week 16 (subjects with baseline BSA ≥3%)."}
• {"endpoint_text":"- 12. 4. ACR50 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":"Proportion achieving both ACR50 and PASI100 simultaneously at Week 16 (in subjects with baseline BSA ≥3%)."}
• {"endpoint_text":"- 13. 5. 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 from baseline at Week 16 (for subjects with baseline sPGA ≥2)."}
• {"endpoint_text":"- 14. 6. HAQ-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. • Change from baseline in the SF-36 v2.0 MCS score at Week 16.","definition_or_measurement_approach":"HAQ-DI responder defined as ≥0.35 reduction from baseline at Week 16; SF-36 MCS change from baseline at Week 16."}
• {"endpoint_text":"- 15. 7. Change from baseline in PsAID-12 total score at Week 16. • Change from baseline in DAPSA score at Week 16.","definition_or_measurement_approach":"Change from baseline in PsAID-12 total and in DAPSA scores at Week 16."}
• {"endpoint_text":"- 16. 8. Change from baseline in DAS28[CRP] score at Week 16. • Change from baseline in PGA-F score in subjects with psoriatic nail involvement (PGA-F>0) at baseline at Week 16.","definition_or_measurement_approach":"DAS28(CRP) and PGA-F change from baseline at Week 16 (PGA-F for subjects with nail involvement at baseline)."}
• {"endpoint_text":"- 17. 9. Zasocitinib Dose B vs. Placebo • Change from baseline in the SF-36 v2.0 PCS score at Week 16. • Change from baseline in the FACIT-Fatigue score at Week 16.","definition_or_measurement_approach":"SF-36 PCS and FACIT-Fatigue change from baseline at Week 16 (Dose B vs placebo)."}
• {"endpoint_text":"- 18. 10. Zasocitinib Dose A vs. active comparator Zasocitinib Dose B vs. active comparator • ACR50 response: Assessed as proportion of subjects achieving ACR50 at Week 16. • ACR70 response: Assessed as proportion of subjects achieving ACR70 at Week 16.","definition_or_measurement_approach":"ACR50 and ACR70 proportions at Week 16 for Dose A and Dose B vs active comparator."}
• {"endpoint_text":"- 19. 11. PASI90 response (in subjects with ≥3% BSA at baseline) at Week 16. • PASI100 response (in subjects with ≥3% BSA at baseline) at Week 16.","definition_or_measurement_approach":"PASI90 and PASI100 proportions at Week 16 (subjects with baseline BSA ≥3%)."}
• {"endpoint_text":"- 20. 12. ACR50 and PASI100 response (in subjects with ≥3% BSA at baseline): Assessed as proportion of subjects simultaneously achieving ACR50 and PASI100 at Week 16. • MDA: Assessed as proportion of subjects achieving MDA status at Week 16.","definition_or_measurement_approach":"ACR50+PASI100 simultaneous proportion and MDA proportion at Week 16."}
• {"endpoint_text":"- 21. • 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":"SPARCC enthesitis resolution proportion through Week 16; ACR20 proportion at Week 8."}

Methods

• Print advertisements (country-specific print ads and posters) targeting potential participants in participating countries.
• Digital advertising and social media (social media ads, social media video scripts, social media packets, widget text) directing to study landing pages and prescreeners.
• Search engine ads (search ads) and digital banners driving to study landing pages/prescreener.
• Doctor-to-doctor outreach and doctor-to-patient emails to inform clinicians and patients, plus GP/primary care notification letters.
• Advocacy engagement (advocacy emails/messages) to patient organisations (advocacy groups referenced in materials).
• Recruitment brochures, flyers, quick reference cards, study guides/ fact sheets and patient-facing printed materials distributed at sites.
• Radio scripts for broadcast channels (country-specific).
• Online landing pages with prescreener questionnaires and study-specific landing page copy to identify potential participants and route them to sites.
• Patient support items and study support items for enrolled participants (logistics and retention materials).

Estonia

Earliest CTIS Part Ii Submission Date

09-04-2025

Latest Decision Or Authorization Date

08-05-2025

Processing Time Days

29

Number Of Sites

5

Number Of Participants

31

Latvia

Earliest CTIS Part Ii Submission Date

31-03-2025

Latest Decision Or Authorization Date

09-05-2025

Processing Time Days

39

Number Of Sites

2

Number Of Participants

6

Hungary

Earliest CTIS Part Ii Submission Date

24-03-2025

Latest Decision Or Authorization Date

06-05-2025

Processing Time Days

43

Number Of Sites

6

Number Of Participants

40

Bulgaria

Earliest CTIS Part Ii Submission Date

15-04-2025

Latest Decision Or Authorization Date

06-06-2025

Processing Time Days

52

Number Of Sites

10

Number Of Participants

81

Italy

Earliest CTIS Part Ii Submission Date

07-04-2025

Latest Decision Or Authorization Date

09-06-2025

Processing Time Days

63

Number Of Sites

9

Number Of Participants

28

Belgium

Earliest CTIS Part Ii Submission Date

07-04-2025

Latest Decision Or Authorization Date

12-05-2025

Processing Time Days

35

Number Of Sites

5

Number Of Participants

13

Germany

Earliest CTIS Part Ii Submission Date

03-04-2025

Latest Decision Or Authorization Date

06-05-2025

Processing Time Days

33

Number Of Sites

8

Number Of Participants

51

Croatia

Earliest CTIS Part Ii Submission Date

23-04-2025

Latest Decision Or Authorization Date

09-06-2025

Processing Time Days

47

Number Of Sites

5

Number Of Participants

24

Poland

Earliest CTIS Part Ii Submission Date

10-04-2025

Latest Decision Or Authorization Date

13-05-2025

Processing Time Days

33

Number Of Sites

27

Number Of Participants

272

Portugal

Earliest CTIS Part Ii Submission Date

06-02-2025

Latest Decision Or Authorization Date

05-06-2025

Processing Time Days

119

Number Of Sites

7

Number Of Participants

20

Spain

Earliest CTIS Part Ii Submission Date

04-04-2025

Latest Decision Or Authorization Date

04-06-2025

Processing Time Days

61

Number Of Sites

7

Number Of Participants

18

Czechia

Earliest CTIS Part Ii Submission Date

06-02-2025

Latest Decision Or Authorization Date

04-06-2025

Processing Time Days

118

Number Of Sites

10

Number Of Participants

68

Primary sponsor

Full Name

Takeda Development Center Americas Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Pharmaceutical Product Development LLC

Name

Suvoda LLC

Name

Cytel Inc.

Responsibilities

Data Monitoring Committee

Name

QPS LLC

Name

Q2 Solutions LLC

Responsibilities

Laboratory testing

Third parties

• {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Caerus Marketing Group LLC","duties_or_roles":"Patient Recruitment","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Data Monitoring Committee","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"Patient Recruitment","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"QPS LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Subject Reimbursement and Stipend","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}