A study to evaluate the efficacy and safety of subcutaneous sonelokimab compared with placebo in adult participants with moderate to severe hidradenitis suppurativa

Overview

Sponsor-declared trial summary

Key facts

Sponsor

MoonLake Immunotherapeutics AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Immune System Diseases [C20]

Trial duration

2 Oct 2024 → 15 May 2026

Decision date (initial)

2024-09-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Moonlake Immunotherapeutics AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Efficacy

To demonstrate the efficacy of sonelokimab compared with placebo with respect to HiSCR75 over 16 weeks of treatment in participants with moderate to severe Hidradenitis Suppurativa (HS).

Secondary objectives 3

1. 1. To evaluate the efficacy of sonelokimab compared with placebo based on other clinical measures of disease activity over 16 weeks of treatment in participants with moderate to severe HS.
2. 2. To evaluate the safety and tolerability of sonelokimab over 52 weeks of treatment in participants with moderate to severe HS.
3. 3. To assess the change from baseline to Week 52 in efficacy measures in participants with moderate to severe HS

Conditions and MedDRA coding

hidradenitis suppurativa (HS)

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 1. Participants must be at least 18 years of age at the time of signing the informed consent
2. 2. Participants must complete at least 4 out of 7 days of eDiary entries in at least 1 of the 2 weeks before randomization.
3. 3. 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.
4. 4. 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).
5. 5. 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.
6. 6. 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.
7. 7. 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
8. 8. 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.

Exclusion criteria 23

1. 1. Participants with a known hypersensitivity to sonelokimab or any of its excipients.
2. 2. 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).
3. 3. Participants with any current nontuberculous mycobacterial infection or any history of nontuberculous mycobacterial infection at the Screening Visit.
4. 4. Participants with a concurrent acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the Screening Visit.
5. 5. Participants with evidence of human immunodeficiency virus (HIV) infection at the Screening Visit.
6. 6. 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.
7. 7. Participants with a history of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
8. 8. Participants with primary immunodeficiencies, prior splenectomy, or suppressive conditions, including participants taking immunosuppressive therapy following organ transplants.
9. 9. 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).
10. 10. 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.
11. 11. 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.
12. 12. 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).
13. 13. 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.
14. 14. 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.
15. 15. Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
16. 16. Participants who have a history of chronic alcohol or drug abuse in the past year before the Screening Visit
17. 17. 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.
18. 18. 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.
19. 19. 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.
20. 20. 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.
21. 21. 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).
22. 22. Participants who have experienced a period of ≥3 weeks of unexplained diarrhea in the 24 weeks before the initiation of study treatment.
23. 23. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of participants achieving HiSCR75 score at Week 16

Secondary endpoints 11

1. 6. Treatment-emergent adverse event (TEAEs)
2. 7. SAEs
3. 8. TEAEs leading to study withdrawal
4. 9. Adverse event of special interest (AESIs)
5. 10. Physical examinations, vital signs, and ECG results
6. 11. Abnormal laboratory parameters (hematology, clinical chemistry, urinalysis)
7. 1. Percentage of participants achieving HiSCR50 at Week 16.
8. 4. Absolute change in HiSQOL score at Week 16
9. 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 .
10. 2. Percentage of participants achieving IHS4-55 at Week 16.
11. 3. Percentage of participants achieving a ≥3-unit reduction at Week 16 in the NRS for pain in PGA among participants with a baseline NRS ≥3

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

MoonLake Immunotherapeutics AG

Sponsor organisation

MoonLake Immunotherapeutics AG

Address

Dorfstrasse 29

City

Zug

Postcode

6300

Country

Switzerland

Scientific contact point

Organisation

MoonLake Immunotherapeutics AG

Contact name

Clinical trial information point

Public contact point

Organisation

MoonLake Immunotherapeutics AG

Contact name

Clinical trial information point

Third parties 5

Locations

8 EU/EEA countries · 57 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 104 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

12 submissions — initial application plus substantial / non-substantial modifications