SONELOKIMAB for Psoriatic arthritis

Inclusion criteria

• {"criterion_text":"- 1.\tParticipants must be ≥18 years of age at the time of signing the informed consent."}
• {"criterion_text":"- 10. Male participants must be willing to use a condom when sexually active with a partner of childbearing potential during the study and for at least 8 weeks after the last dose of study treatment, unless surgically sterile. Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment."}
• {"criterion_text":"- 11.\tParticipants are considered reliable and capable of adhering to the protocol, visit schedule, or medication intake, according to the judgment of the investigator."}
• {"criterion_text":"- 12.\tParticipants are able to understand and provide signed informed consent (see protocol Appendix 1)."}
• {"criterion_text":"- 2.\tParticipants who have a confirmed diagnosis of PsA per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 months before the Screening Visit."}
• {"criterion_text":"- 3. Participants who have active disease (defined by a 68 tender joint count [TJC68] of ≥3 and a 66 swollen joint count [SJC66] of ≥3 at Screening Visit and confirmed at Randomization Visit)."}
• {"criterion_text":"- 4.\tParticipants who have current active plaque PsO with ≥1 psoriatic plaque of ≥2 cm or nail changes consistent with PsO or a dermatologist-confirmed personal history of plaque PsO."}
• {"criterion_text":"- 5.\tParticipants who test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit."}
• {"criterion_text":"- 6. Participants should have (a)\tbeen taking a stable dose of NSAIDs for a period of ≥4 consecutive weeks, any time prior to screening, with inadequate control of symptoms, or (b)\tshould have a documented intolerance or contraindication to ≥1 NSAID."}
• {"criterion_text":"- 7.\tParticipants should have had an inadequate response to ≥1 nonbiological conventional synthetic DMARDs (csDMARDs) [methotrexate, sulfasalazine, leflunomide], taken for at least 12 weeks (with a stable dose for ≥8 weeks), or should have a documented intolerance to or contraindication to at least one of these csDMARDs as defined by the investigator. Note: in case csDMARDs were discontinued before enrollment in this study, the washout requirements in Section 6.9 (Table 7) should be followed."}
• {"criterion_text":"- 8. Participants must have the presence of at least one of the following at the Screening Visit: (a)\t≥1 erosion based on the Screening plain X-rays of hands and feet, as determined by centralized imaging review. (b)\tA hs-CRP value greater than the central laboratory-defined upper limit of normal."}
• {"criterion_text":"- 9. Female participants are eligible to participate if they are not pregnant or breastfeeding and must be of nonchildbearing potential or (if women of childbearing potential [WOCBP]) must agree to use highly effective methods of contraception during the study and for at least 8 weeks after the last dose of study treatment. WOCBP must have a negative urine pregnancy test at screening and a negative urine pregnancy test at Week 0/Day 1 before initiation of study treatment. Female participants of childbearing potential must refrain from donating oocytes during the study and for at least 8 weeks after the last dose of study treatment. See Appendix 4 for the definitions of nonchildbearing potential, childbearing potential, and highly effective methods of contraception."}

Exclusion criteria

• {"criterion_text":"- 1.\tParticipants with a known hypersensitivity to sonelokimab or any of its excipients."}
• {"criterion_text":"- 2.\tParticipants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA, including but not limited to rheumatoid arthritis, reactive arthritis, enteropathic arthritis, ankylosing spondylitis, sarcoidosis, atopic dermatitis, and systemic or cutaneous lupus erythematosus."}
• {"criterion_text":"- 20.\tParticipants who have had major surgery (including joint surgery) within 6 months before the Baseline Visit or are planning to have major surgery during the study."}
• {"criterion_text":"- 21. Participants with severe cardiovascular comorbidities including but not limited to: documented history of myocardial infarction, unstable angina pectoris stroke, presence of heart failure (New York Heart Association classification III or IV), or evidence of severe, uncontrolled hypertension (characterized by 2 BP measurements separated by ≥15 minutes with systolic BP >180 mmHg or diastolic BP >120 mmHg)."}
• {"criterion_text":"- 22. Participants with any other clinically significant medical conditions or any other reason, including any medical or surgical procedure or any physical, psychological, or psychiatric condition that could, in the opinion of the investigator, compromise the participant’s safety, interfere with their participation in the study, make the participant an unsuitable candidate to receive study treatment, or put the participant or study data at risk."}
• {"criterion_text":"- 23.\tParticipants who currently use or plan to use one or more of the prohibited treatments specified in this protocol (unless permitted according to criteria in protocol Section 6.9)"}
• {"criterion_text":"- 24. Participants who have received a live (including attenuated) vaccination within 8 weeks before the Baseline Visit or plan to receive a live vaccination during the study and up to 8 weeks after the last dose of study treatment. Examples of restricted vaccinations include, but are not limited to: (a)\tZoster vaccine live (Zostavax). (b)\tMeasles-mumps-rubella or measles-mumps-rubella-varicella. (c)\tMonovalent live attenuated influenza A (intranasal). (d)\tOral polio. (e)\tRotavirus. (f)\tSeasonal trivalent live attenuated influenza (intranasal). (g)\tSmallpox. (h)\tOral typhoid. (i)\tVaricella (chicken pox). (j)\tYellow fever."}
• {"criterion_text":"- 25.\tParticipants with clinically significant ECG abnormalities on centrally read ECG at the Screening Visit. Clinically significant ECG abnormalities are considered changes that often indicate underlying cardiac conditions that may require immediate medical attention."}
• {"criterion_text":"- 26. Participants with laboratory abnormalities at the Screening Visit, including any of the following: (a)\tAspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) >3×upper limit of normal (ULN). (b)\tSerum direct bilirubin >1.5×ULN. (c)\tWhite blood cell count <3.0×10^9/L. (d)\tAbsolute neutrophil count <1.5×10^9/L. (e)\tAbsolute lymphocyte count <0.8×10^9/L. (f)\tPlatelet count <100×10^9/L. (g)\tHemoglobin <85 g/L. (h)\tCreatinine clearance <30 mL/min"}
• {"criterion_text":"- 27.\tAny other laboratory abnormality that could, in the opinion of the investigator, compromise the participant’s safety, prevent the participant from completing the study, or interfere with the interpretation of the study results."}
• {"criterion_text":"- 28.\tParticipants who have a history of chronic alcohol or drug abuse in the past year before the Screening Visit."}
• {"criterion_text":"- 12.\tParticipants who have an active infection or history of infections, including any of the following: a.\tAny infection (exception: common cold) requiring systemic treatment within 14 days before the Baseline Visit. b.\tSerious infection, defined as infection requiring hospitalization or intravenous anti-infective treatment, within 2 months before the Baseline Visit. c.\tHistory of opportunistic infections caused by uncommon pathogens (eg, Pneumocystis jirovecii, Blastomyces, aspergillus, cryptococcosis), or severe infections caused by common pathogens (eg, cytomegalovirus, severe herpes zoster [ie, multidermatomal herpes zoster, herpes zoster with organ involvement, ophthalmic herpes, or recurrent herpes zoster, defined as 2 episodes within 2 years before the Baseline Visit]). d.\tHistory of other opportunistic, recurrent, or chronic infections that, in the opinion of the investigator, might cause study participation to be detrimental to the participant. e.\tCandida infection requiring systemic therapy for ≥7 days in the last 12 months before the Baseline Visit. f.\tAny history of esophageal or systemic candidiasis. g.\tCurrent active candidiasis or Candida infection within the 1 month before the Baseline Visit. h.\tConcurrent acute or chronic viral hepatitis B or C, or human immunodeficiency virus (HIV)."}
• {"criterion_text":"- 13.\tParticipants with evidence of TB infection (active, history of active, latent or history of latent) at the Screening Visit."}
• {"criterion_text":"- 14.\tParticipants with any current nontuberculous mycobacterial infection or any history of nontuberculous mycobacterial infection at the Screening Visit."}
• {"criterion_text":"- 15.\tParticipants with a concurrent malignancy or a history of malignancy during the past 5 years of the Baseline Visit, with the following exceptions: a.\t≤3 excised or ablated basal cell carcinomas of the skin. b.\tOne squamous cell carcinoma of the skin not worse than Stage T1 that has been successfully excised or ablated (no other previous treatments allowed), with no signs of recurrence or metastases for ≥2 years before the Baseline Visit. c.\tActinic keratosis. d.\tSquamous cell carcinoma in situ of the skin successfully excised or ablated at >6 months before the Baseline Visit. e.\tLocalized carcinoma in situ of the cervix, treated and considered cured."}
• {"criterion_text":"- 16. Participants with any condition that in the investigator’s judgement may potentially interfere with study efficacy assessments, including but not limited to fibromyalgia and reactivated osteoarthritis."}
• {"criterion_text":"- 17.\tParticipants with erythrodermic, guttate, or pustular form of PsO or drug-induced PsO."}
• {"criterion_text":"- 18. Participants with a history of a lymphoproliferative disorder, including lymphoma, or current signs and symptoms suggestive of lymphoproliferative disease."}
• {"criterion_text":"- 19.\tParticipants with primary immunodeficiencies, prior splenectomy, or suppressive conditions, including participants taking immunosuppressive therapy following organ transplants."}
• {"criterion_text":"- 3.\tParticipants with a confirmed or suspected diagnosis of inflammatory bowel disease (eg, ulcerative colitis or Crohn’s disease), either in medical history or currently present."}
• {"criterion_text":"- 4. Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit."}
• {"criterion_text":"- 5.\tParticipants who currently, or in their history, have an established diagnosis of arthritis mutilans. Note: participants with any other PsA clinical subtype (eg, symmetrical polyarthritis, asymmetrical oligoarthritis, distal interphalangeal arthritis, and arthritis with axial involvement) are eligible for the study."}
• {"criterion_text":"- 6.\tPrevious exposure to sonelokimab."}
• {"criterion_text":"- 7. Participants who have ever received: (a)\tAny biologic immunomodulating agents for PsA or PsO, whether investigational or approved. (b)\tAny investigational agent for PsA or PsO, if given ≤ 5 half-lives prior to randomization. (c)\tAny biologic treatment for any other indication, if given ≤ 5 half-lives prior to randomization."}

Primary endpoints

• {"endpoint_text":"- Proportion of participants achieving ACR50 (ie, ≥50% improvement on the ACR response criteria) at Week 16","definition_or_measurement_approach":"ACR50 defined as ≥50% improvement on the ACR response criteria, measured at Week 16"}

Secondary endpoints

• {"endpoint_text":"- 1. Proportion of participants achieving ACR20 (ie, ≥20% improvement on the ACR response criteria) at Week 16","definition_or_measurement_approach":"ACR20 defined as ≥20% improvement on the ACR response criteria, measured at Week 16"}
• {"endpoint_text":"- 2. Proportion of participants achieving Minimal Disease Activity (MDA) at Week 16","definition_or_measurement_approach":"Minimal Disease Activity assessed at Week 16"}
• {"endpoint_text":"- 3. Change from Baseline in Health Assessment Questionnaire—Disability Index (HAQ-DI) at Week 16","definition_or_measurement_approach":"Change from baseline in HAQ-DI score at Week 16"}
• {"endpoint_text":"- 4. Proportion of participants achieving a decrease of ≥90% in the Psoriasis Area and Severity Index (PASI90) response at Week 16 in the subgroup of participants with PsO involving ≥3% body surface area at Baseline","definition_or_measurement_approach":"PASI90 (≥90% reduction in PASI) at Week 16 in baseline PsO ≥3% BSA subgroup"}
• {"endpoint_text":"- 5. Change from Baseline in SF-36 PCS at Week 16","definition_or_measurement_approach":"Change from baseline in SF-36 Physical Component Summary at Week 16"}
• {"endpoint_text":"- 6. Change from Baseline to Week 16 in joint/bone structural damage (van der Heijde modified Total Sharp Score)","definition_or_measurement_approach":"Change from baseline in van der Heijde modified Total Sharp Score at Week 16"}
• {"endpoint_text":"- 7. Incidence, relatedness, severity, and seriousness of TEAEs","definition_or_measurement_approach":"Treatment-emergent adverse events: incidence, investigator-assessed relatedness, severity, and seriousness over study"}
• {"endpoint_text":"- 8. Withdrawal due to TEAEs","definition_or_measurement_approach":"Number/proportion of participants withdrawing due to treatment-emergent adverse events"}
• {"endpoint_text":"- 9. Clinically relevant abnormalities in vital signs (blood pressure and heart rate) and body weight","definition_or_measurement_approach":"Clinically relevant changes in BP, HR, and body weight captured during study visits"}
• {"endpoint_text":"- 10. Clinically relevant abnormalities in 12-lead ECG variables","definition_or_measurement_approach":"Clinically relevant changes in 12‑lead ECG variables as centrally reviewed"}
• {"endpoint_text":"- 11. Clinically relevant abnormalities in laboratory parameters (hematology, biochemistry, and urinalysis)","definition_or_measurement_approach":"Clinically relevant laboratory abnormalities in hematology, biochemistry, and urinalysis"}

Latvia

Earliest CTIS Part Ii Submission Date

21-02-2025

Latest Decision Or Authorization Date

12-03-2025

Processing Time Days

19

Number Of Participants

10

Greece

Earliest CTIS Part Ii Submission Date

21-11-2024

Latest Decision Or Authorization Date

11-03-2025

Processing Time Days

110

Number Of Participants

6

Germany

Earliest CTIS Part Ii Submission Date

28-01-2025

Latest Decision Or Authorization Date

13-03-2025

Processing Time Days

44

Number Of Participants

20

Spain

Earliest CTIS Part Ii Submission Date

21-11-2024

Latest Decision Or Authorization Date

11-03-2025

Processing Time Days

110

Number Of Participants

29

Bulgaria

Earliest CTIS Part Ii Submission Date

28-02-2025

Latest Decision Or Authorization Date

12-03-2025

Processing Time Days

12

Number Of Participants

80

Finland

Earliest CTIS Part Ii Submission Date

20-02-2025

Latest Decision Or Authorization Date

21-03-2025

Processing Time Days

29

Number Of Participants

6

Romania

Earliest CTIS Part Ii Submission Date

21-11-2024

Latest Decision Or Authorization Date

17-03-2025

Processing Time Days

116

Number Of Participants

9

Hungary

Earliest CTIS Part Ii Submission Date

20-02-2025

Latest Decision Or Authorization Date

14-03-2025

Processing Time Days

22

Number Of Participants

26

Estonia

Earliest CTIS Part Ii Submission Date

14-02-2025

Latest Decision Or Authorization Date

17-03-2025

Processing Time Days

31

Number Of Participants

7

Croatia

Earliest CTIS Part Ii Submission Date

14-02-2025

Latest Decision Or Authorization Date

17-03-2025

Processing Time Days

31

Number Of Participants

5

Portugal

Earliest CTIS Part Ii Submission Date

24-02-2025

Latest Decision Or Authorization Date

13-03-2025

Processing Time Days

17

Number Of Participants

6

Lithuania

Earliest CTIS Part Ii Submission Date

19-02-2025

Latest Decision Or Authorization Date

13-03-2025

Processing Time Days

22

Number Of Participants

12

Czechia

Earliest CTIS Part Ii Submission Date

20-02-2025

Latest Decision Or Authorization Date

12-03-2025

Processing Time Days

20

Number Of Participants

51

Slovakia

Earliest CTIS Part Ii Submission Date

12-02-2025

Latest Decision Or Authorization Date

10-03-2025

Processing Time Days

26

Number Of Participants

14

France

Earliest CTIS Part Ii Submission Date

25-02-2025

Latest Decision Or Authorization Date

10-03-2025

Processing Time Days

13

Number Of Participants

11

Poland

Earliest CTIS Part Ii Submission Date

20-02-2025

Latest Decision Or Authorization Date

26-03-2025

Processing Time Days

34

Number Of Participants

500

Primary sponsor

Full Name

MoonLake Immunotherapeutics AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

PRA Hellas CRO A.E.

Responsibilities

CRO

Name

Icon Clinical Research Limited

Responsibilities

CRO

Third parties

• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"QPS LLC","duties_or_roles":"PK & ADA","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA & ECG services","organisation_type":"Pharmaceutical company"}
• {"country":"Sweden","full_name":"Olink Proteomics AB","duties_or_roles":"Serum biomarkers","organisation_type":"Pharmaceutical company"}