SONELOKIMAB for Hidradenitis suppurativa

Stratification factors

• Hurley Stage status (II and III)
• Prior biologic use (Yes/No)
• Geographic region

Inclusion criteria

• {"criterion_text":"- Participants must be at least 18 years of age at the time of signing the informed consent."}
• {"criterion_text":"- Participants must complete at least 4 out of 7 days of eDiary entries in at least 1 of the 2 weeks before randomization."}
• {"criterion_text":"- Participants who are diagnosed with HS as determined by the investigator and have a history of signs and symptoms of HS for ≥6 months before signing the informed consent."}
• {"criterion_text":"- Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of HS (or demonstrated intolerance to, or had a contraindication to, systemic antibiotics for treatment of their HS), in the investigator’s opinion. Typical duration of treatment before an inadequate response is declared should be no less than 8 to 12 weeks in accordance with to the recommendations in US and European guidelines."}
• {"criterion_text":"- Participants enrolling in the antibiotic cohort must be on a stable dose (defined as a dose or dose regimen that has not changed in the previous 28 days before the initiation of study treatment)."}
• {"criterion_text":"- Female participants are eligible to participate if they are not pregnant or breastfeeding and must be of nonchildbearing potential or (if 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 participant 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 definition of nonchildbearing potential, childbearing potential, and highly effective methods of contraception."}
• {"criterion_text":"- Male participants must be willing to use a condom when sexually active with a WOCBP partner 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":"- Participants must be capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol."}

Exclusion criteria

• {"criterion_text":"- Participants with a known hypersensitivity to sonelokimab or any of its excipients."}
• {"criterion_text":"- Participants who are enrolled in another interventional investigational study for a device or drug or have been so enrolled in the last 28 days before the initiation of study treatment or within 5 half-lives of the investigational study drug before the initiation of study treatment, whichever is longer."}
• {"criterion_text":"- Participants with clinically significant electrocardiogram (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":"- Participants with laboratory abnormalities at the Screening Visit, including any of the following: a. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) >3× upper limit of normal (ULN). b. Serum direct bilirubin >1.5×ULN (in the absence of known Gilbert syndrome). c. White blood cell count <3×10^9/L. d. Absolute neutrophil count <1.5×10^9/L. e. Absolute lymphocyte count <0.7×10^9/L. f. Platelet count <100×10^9/L. g. Hemoglobin <85 g/L. h. Creatinine clearance <30 mL/min (by Cockcroft Gault formula)."}
• {"criterion_text":"- Any other laboratory abnormality which, in the opinion of the investigator, might compromise participant’s safety, prevent the participant from completing the study or would interfere with the interpretation of the study results."}
• {"criterion_text":"- Participants who have had major surgery (e.g., hip replacement, aneurysm removal) within 6 months before the initiation of study treatment or are planning to have major surgery during the study."}
• {"criterion_text":"- Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS."}
• {"criterion_text":"- Participants who have a history of chronic alcohol or drug abuse in the past year before the Screening Visit."}
• {"criterion_text":"- Participants who are an employee or a direct relative of an employee of the sponsor, a study center, or a third-party organization involved in the study."}
• {"criterion_text":"- Participants with underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, or cardiac) that, in the opinion of the investigator, potentially places the participant at unacceptable risk."}
• {"criterion_text":"- Participants with current severe or uncontrolled disease(s) that put(s) the participant at increased risk, including any medical or psychiatric condition that, in the investigator’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol."}
• {"criterion_text":"- Participants with evidence of tuberculosis (TB) infection (active, history of active, latent or history of latent) at the Screening Visit. Participants may still enter the study if they have documented evidence that they have completed sufficient treatment, according to local routine clinical practice, at least 4 weeks before randomization. If they completed their treatment at least 4 weeks before and within 24 months of the Baseline Visit, to be enrolled they need to have documented evidence of treatment and have no evidence of active or latent disease. If they completed their treatment over 24 months before baseline, to be enrolled they need to have been adequately treated and confirmed to be fully recovered upon consultation with a TB specialist (see Section 8.1.3)."}
• {"criterion_text":"- Participants with any other known autoimmune disease or any medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS, prevent participants from complying with protocol requirements (including the requirement for prohibited medications), or put the participant at undue risk."}
• {"criterion_text":"- Participants with a confirmed or suspected diagnosis of inflammatory bowel disease (eg, ulcerative colitis or Crohn’s disease), either in medical history or currently present. Note: participants with functional gastrointestinal disorders (eg, irritable bowel syndrome) can be considered eligible for enrolment if inflammatory bowel disease has been excluded and documented (eg, formal clinical criteria, endoscopy, fecal calprotectin stool test)."}
• {"criterion_text":"- Participants who have experienced a period of ≥3 weeks of unexplained diarrhea in the 24 weeks before the initiation of study treatment."}
• {"criterion_text":"- Participants with an active infection or history of infections including any of the following: a. Any infection (exception: common cold) requiring systemic anti-infective treatment within 14 days before initiation of study treatment. b. Serious infection, defined as requiring hospitalization or intravenous anti-infectives, within 2 months before initiation of study treatment. c. Candida infection requiring systemic therapy for ≥7 days in the last 12 months before initiation of study treatment. d. Previous esophageal or systemic candidiasis. e. Current active candidiasis or Candida infection within the last 3 months before the initiation of study treatment."}
• {"criterion_text":"- Participants with any current nontuberculous mycobacterial infection or any history of nontuberculous mycobacterial infection at the Screening Visit."}
• {"criterion_text":"- Participants with a concurrent acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the Screening Visit."}
• {"criterion_text":"- Participants with evidence of human immunodeficiency virus (HIV) infection at the Screening Visit."}
• {"criterion_text":"- Participants with a concurrent malignancy or a history of malignancy within 5 years of the initiation of study treatment with the following exceptions: a. Three or fewer successfully excised or ablated basal cell carcinomas of the skin. b. One squamous cell carcinoma of the skin not worse than Stage T1 that has been successfully treated, with no signs of recurrence or metastases for at least the past 2 years before study treatment initiation. c. Actinic keratosis. d. Squamous cell carcinoma in situ of the skin successfully treated >6 months before study treatment initiation. e. Localized carcinoma in situ of the cervix treated and considered cured."}
• {"criterion_text":"- Participants with a history of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease."}
• {"criterion_text":"- Participants with primary immunodeficiencies, prior splenectomy, or suppressive conditions, including participants taking immunosuppressive therapy following organ transplants."}
• {"criterion_text":"- Participants who currently use or plan to use one or more prohibited treatments specified in this protocol unless permitted according to criteria in Section 6.9.1, including high-potency opioid analgesics [eg, methadone, hydromorphone, or morphine], GLP-1 analogs, or ongoing use of prohibited HS treatments/medications [eg, systemic or topical corticosteroids] at baseline)."}

Primary endpoints

• {"endpoint_text":"- Percentage of participants achieving HiSCR75 at Week 16","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Treatment-emergent adverse event (TEAEs)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Serious adverse event (SAEs)","definition_or_measurement_approach":""}
• {"endpoint_text":"- TEAEs leading to study withdrawal","definition_or_measurement_approach":""}
• {"endpoint_text":"- Adverse event of special interest (AESIs)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Physical examinations, vital signs, and ECG results","definition_or_measurement_approach":""}
• {"endpoint_text":"- Abnormal laboratory parameters (hematology, clinical chemistry, urinalysis)","definition_or_measurement_approach":""}
• {"endpoint_text":"- 1. Percentage of participants achieving HiSCR50 at Week 16","definition_or_measurement_approach":""}
• {"endpoint_text":"- 2. Percentage of participants achieving IHS4-55 at Week 16","definition_or_measurement_approach":""}
• {"endpoint_text":"- 5. Percentage of participants achieving a DLQI total reduction of ≥4 (minimal clinically important difference) at Week 16 among participants with a baseline DLQI ≥4","definition_or_measurement_approach":""}
• {"endpoint_text":"- 3. Percentage of participants achieving a ≥3-unit reduction at Week 16 in the NRS for skin pain in PGA among participants with a baseline NRS ≥3","definition_or_measurement_approach":""}
• {"endpoint_text":"- 4. Absolute change in HiSQOL score at Week 16","definition_or_measurement_approach":""}

Netherlands

Earliest CTIS Part Ii Submission Date

22-08-2024

Latest Decision Or Authorization Date

27-06-2025

Processing Time Days

309

Number Of Sites

1

Number Of Participants

9

Slovakia

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

24-06-2025

Processing Time Days

329

Number Of Sites

2

Number Of Participants

8

Czechia

Earliest CTIS Part Ii Submission Date

06-08-2024

Latest Decision Or Authorization Date

26-06-2025

Processing Time Days

324

Number Of Sites

3

Number Of Participants

26

France

Earliest CTIS Part Ii Submission Date

06-08-2024

Latest Decision Or Authorization Date

23-06-2025

Processing Time Days

321

Number Of Sites

11

Number Of Participants

41

Bulgaria

Earliest CTIS Part Ii Submission Date

21-08-2024

Latest Decision Or Authorization Date

09-09-2025

Processing Time Days

384

Number Of Sites

5

Number Of Participants

18

Spain

Earliest CTIS Part Ii Submission Date

31-05-2024

Latest Decision Or Authorization Date

05-11-2025

Processing Time Days

523

Number Of Sites

20

Number Of Participants

41

Poland

Earliest CTIS Part Ii Submission Date

01-08-2024

Latest Decision Or Authorization Date

30-06-2025

Processing Time Days

333

Number Of Sites

8

Number Of Participants

80

Ireland

Earliest CTIS Part Ii Submission Date

19-07-2024

Latest Decision Or Authorization Date

23-06-2025

Processing Time Days

339

Number Of Sites

1

Number Of Participants

3

Belgium

Earliest CTIS Part Ii Submission Date

05-08-2024

Latest Decision Or Authorization Date

24-06-2025

Processing Time Days

323

Number Of Sites

4

Number Of Participants

6

Germany

Earliest CTIS Part Ii Submission Date

05-08-2024

Latest Decision Or Authorization Date

07-11-2025

Processing Time Days

459

Number Of Sites

14

Number Of Participants

60

Primary sponsor

Full Name

MoonLake Immunotherapeutics AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

Operational CRO activities (sponsorDuties codes: 1,12,2,5,6)

Name

QPS LLC

Responsibilities

PK & ADA

Name

Medidata Solutions Inc.

Responsibilities

eClinical platform services

Third parties

• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes:1,12,2,5,6","organisation_type":"Pharmaceutical company / CRO"}
• {"country":"United States","full_name":"QPS LLC","duties_or_roles":"PK & ADA","organisation_type":"Pharmaceutical company / CRO"}
• {"country":"Sweden","full_name":"Olink Proteomics AB","duties_or_roles":"Serum biomarkers","organisation_type":"Pharmaceutical company / vendor"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"eClinical platform (code 7)","organisation_type":"Non-Pharmaceutical company / vendor"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA & ECG services","organisation_type":"Pharmaceutical company / vendor"}