Sonelokimab for Hidradenitis Suppurativa

Enrolling by invitation at 22 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: MoonLake Immunotherapeutics AG

Must be taking: Sonelokimab

Disqualifiers: Pregnancy, Breastfeeding, Other studies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests sonelokimab, a treatment for individuals with moderate to severe hidradenitis suppurativa, a condition causing painful lumps under the skin. The goal is to assess the long-term safety and effectiveness of sonelokimab. Participants who completed a previous study with sonelokimab and wish to continue treatment may qualify to join. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications, but it mentions that certain treatments are prohibited. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that sonelokimab is likely to be safe for humans?

Research has shown that sonelokimab is safe for people with hidradenitis suppurativa, a skin condition. In one study, participants tolerated sonelokimab well, and it significantly improved their skin symptoms without any unexpected safety issues.

The treatment has undergone testing in several studies, where it outperformed a placebo, making it a promising option. While side effects can occur with any treatment, the safety data for sonelokimab reassures those considering joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hidradenitis suppurativa?

Unlike the standard treatments for hidradenitis suppurativa, which typically include antibiotics, corticosteroids, or biologics like adalimumab, sonelokimab offers a unique approach. Sonelokimab works by targeting interleukin-17A and interleukin-17F, proteins involved in inflammatory processes, with the potential for more precise inflammation control. This mechanism could lead to fewer side effects and improved effectiveness compared to existing options. Researchers are excited because sonelokimab’s targeted action might provide better relief for patients who don't respond well to current therapies.

What evidence suggests that sonelokimab might be an effective treatment for hidradenitis suppurativa?

Research has shown that sonelokimab may help treat hidradenitis suppurativa, a long-lasting skin condition. In one study, 35.4% of patients using sonelokimab experienced a 75% reduction in symptoms, compared to 21.6% of those who received a placebo. Additionally, about 25% of patients showed no signs of inflammation after 24 weeks. These results suggest that sonelokimab can effectively lessen the severity of this condition. Participants in this trial will receive 120 mg of sonelokimab every four weeks for up to two years. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with moderate to severe hidradenitis suppurativa, a chronic skin condition causing painful lumps under the skin. Participants should have been part of an earlier sonelokimab study.

Inclusion Criteria

I completed a previous study (M1095-HS-301, M1095-HS-302, or M1095-HS-304) and can continue with sonelokimab.

I agree to use a condom and not donate sperm during and for 8 weeks after the study.

I am not pregnant or breastfeeding.

Exclusion Criteria

Participants who meet any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study

Participants who have ongoing or planned to use one or more of the prohibited HS or non-HS treatments specified in the protocol

Participants who plan to participate in another interventional study for a drug or device during this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sonelokimab 120 mg subcutaneously every 4 weeks

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Open-label extension

Participants continue to receive sonelokimab to evaluate long-term safety, tolerability, and efficacy

2.5-3 years

What Are the Treatments Tested in This Trial?

Interventions

• Sonelokimab

Trial Overview The focus is on long-term safety and effectiveness of Sonelokimab when given as a subcutaneous injection to those with hidradenitis suppurativa. It's an extension of previous research on this medication.

How Is the Trial Designed?

Group I: Experimental: sonelokimab Experimental Treatment 1 Intervention

All participants will receive sonelokimab 120 mg Q4W for up to 2 years

Who Is Running the Clinical Trial?

MoonLake Immunotherapeutics AG

Lead Sponsor

Trials

7

Recruited

2,800+

Citations

1. ir.moonlaketx.com ir.moonlaketx.com/news-releases/news-release-details/moonlake-immunotherapeutics-reports-week-16-results-vela-phase-3

Press releases In June 2023, topline results of the MIRA trial (NCT05322473) at 12 weeks showed that the trial met its primary endpoint, the Hidradenitis ...

2. dermatologytimes.com dermatologytimes.com/view/moonlake-shares-findings-from-dual-phase-3-trials-of-sonelokimab

MoonLake Shares Findings from Dual Phase 3 Trials of ... Sonelokimab demonstrated significant efficacy in hidradenitis suppurativa, achieving HiSCR75 response rates of 35.4% versus 21.6% for ...

3. jaad.org jaad.org/article/S0190-9622(25)01616-0/abstract

and IL-17F-inhibiting Nanobody sonelokimab in patients ... Furthermore, for 1 in 4 patients, inflammatory remission in the form of IHS4-100 was possible after 24 weeks of treatment with sonelokimab 120mg. Ongoing Phase ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07007637

NCT07007637 | A Study to Evaluate the Long-term Safety, ... This is a study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe hidradenitis suppurativa who ...

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/moonlake-therapeutics-sonelokimab-hs-ppp-clinical-trials/

MoonLake claws back HS potential for sonelokimab on ... HiSCR75 is a common clinical outcome measure that quantifies a patient achieving a 75% reduction from baseline in HS-associated inflammatory ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40601333/

A Living Systematic Review and Network Meta-Analysis Main outcomes and measures: Primary efficacy, safety, and tolerability outcomes were Hidradenitis Suppurativa Clinical Response (HiSCR)-50 ...

7. hcplive.com hcplive.com/view/phase-3-vela-study-findings-suggest-sonelokimab-effective-hs

Phase 3 VELA Study Findings Suggest Sonelokimab ... In June 2023, topline findings from the MIRA trial showed that the study met its primary endpoint at 12-weeks for Hidradenitis Suppurativa ...