A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in 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]

Trial duration

16 Oct 2025 → ongoing

Decision date (initial)

2025-08-29

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: Others, Efficacy, Safety

To evaluate the long-term safety and tolerability of sonelokimab in participants with moderate to severe HS

Secondary objectives 2

1. 1. To evaluate the long-term efficacy of sonelokimab in participants with moderate to severe HS
2. 2. To evaluate the long-term efficacy of sonelokimab in participants with moderate to severe HS, in terms of participant-reported symptoms and quality of life

Conditions and MedDRA coding

Hidradenitis suppurativa (HS)

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1. Participants who have received the second to last and/or last dose, as planned in the parental study, and have completed the EOT visit (Week 52 [M1095-HS-301/302] or Week 24 [M1095-HS-304]).
2. 2. Participants must have received their last dose of study treatment in the parental study no more than 8 weeks before the first dose in this OLE study.
3. 3. 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 in the week prior to the first administration of study treatment in this study (Week 0). 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 Protocol Appendix 1 for the definitions of nonchildbearing potential, childbearing potential, and highly effective methods of contraception).
4. 4. 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.
5. 5. Participants are considered reliable and capable of adhering to the protocol, visit schedule, and medication intake, according to the judgment of the investigator.
6. 6. Participants are able to understand and provide signed informed consent, or assent with parental/legal guardian consent, as applicable, per local regulations and guidelines.

Exclusion criteria 3

1. 1. Participants who meet any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study, as below:
2. 2. Participants who have ongoing or planned to use one or more of the prohibited HS or non-HS treatments specified in this protocol (Section 6.9.2).
3. 3. Participants who plan to participate in another interventional study for a drug or device during this study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 6

1. 1. Treatment-emergent adverse event (TEAEs)
2. 2. Serious adverse event (SAEs)
3. 3. TEAEs leading to study withdrawal
4. 4. Adverse event of special interest (AESIs)
5. 5. Vital signs, and ECG results
6. 6. Abnormal laboratory parameters (hematology, clinical chemistry)

Investigational products

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

Test 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 4

Locations

13 EU/EEA countries · 108 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 168 files

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

Application history

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