Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa

Recruiting at 60 trial locations

Overseen By MoonLake Clinical Trial Helpdesk

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: MoonLake Immunotherapeutics AG

Must be taking: Adalimumab

Must not be taking: Biologic modifiers

Disqualifiers: Ulcerative colitis, Crohn's disease, others

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

Compensation: Varies

Number of Visits: Unknown

234 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the effectiveness and safety of a new treatment for adults with moderate to severe hidradenitis suppurativa, a painful skin condition. The treatment aims to reduce symptoms.

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

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have had an inadequate response to systemic antibiotics, suggesting that some medications might be continued. Please consult with the trial investigator for specific guidance.

What data supports the effectiveness of the drug Sonelokimab?

Research shows that Sonelokimab, a drug targeting IL-17A and IL-17F, has shown promising results in early studies for treating psoriasis, a skin condition. It works by blocking specific proteins involved in inflammation, and studies have shown it can help improve symptoms in patients with this condition. ^{1 2 3 4 5}

Is Sonelokimab safe for humans?

Sonelokimab has been tested in phase I and II studies for psoriasis, showing promising safety results. These studies suggest it is generally safe for human use. ^{1 2 3 5 6}

What makes the drug Sonelokimab unique for treating psoriasis?

Sonelokimab is unique because it is a trivalent nanobody derived from camelid antibodies, targeting both IL-17A and IL-17F, which are involved in the inflammation process of psoriasis. This dual targeting approach may offer better disease control compared to treatments that only target IL-17A. ^{1 2 3 4 7}

Research Team

Prof. Kristian Reich, M.D., Ph.D. (equ.)

Principal Investigator

MoonLake Immunotherapeutics AG

Eligibility Criteria

Inclusion Criteria

Participant must be, in the opinion of the investigator, at both the Screening Visit and study treatment initiation, a suitable candidate for treatment with adalimumab per approved local product information.

You have previously tried antibiotics to treat your hidradenitis suppurativa, but they did not work or caused side effects.

Participant has hidradenitis suppurativa lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (i.e., be Hurley Stage II or III);

Exclusion Criteria

You are allergic to sonelokimab or any substances used to make it.

Participant has a draining fistula count of ≥20 at the Screening Visit;

You have another ongoing skin condition that might affect the evaluation of your hidradenitis suppurativa.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-Blind Treatment

Participants receive either sonelokimab, adalimumab, or placebo subcutaneously

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label Extension

Participants may opt into continuation of treatment with sonelokimab

Long-term

Treatment Details

Interventions

• Sonelokimab

Participant Groups

Group I: sonelokimab dose 2 Experimental Treatment 1 Intervention

Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.

Group II: sonelokimab dose 1 Experimental Treatment 1 Intervention

Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.

Group III: adalimumab Active Control 1 Intervention

Subjects randomized to this arm will receive adalimumab during the Double-Blind Treatment Period and will be reallocated to receive sonelokimab dosage regimen during Part B.

Group IV: Placebo Placebo Group 1 Intervention

Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be re-randomized to receive a sonelokimab dosage regimen during Part B.

Who Is Running the Clinical Trial?

MoonLake Immunotherapeutics AG

Lead Sponsor

Trials

7

Recruited

2,800+

Findings from Research

Bimekizumab, a dual inhibitor targeting both IL-17A and IL-17F, has shown efficacy and safety in treating psoriasis and psoriatic arthritis across multiple phases of clinical trials (I, II, and III).

Sonelokimab, a trivalent nanobody also targeting IL-17A and IL-17F, has demonstrated promising results in early phase studies for psoriasis, indicating potential for effective treatment options in these chronic immune-mediated disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual inhibition of IL-17A and IL-17F in psoriatic disease. Iznardo, H., Puig, L.[2021]

In a phase 2b trial involving 313 participants with moderate to severe plaque-type psoriasis, sonelokimab demonstrated significant efficacy, with 48.1% of patients in the 30 mg group and up to 88.2% in the 120 mg augmented load group achieving clear or almost clear skin (IGA score of 0 or 1) at week 12, compared to 0% in the placebo group.

Sonelokimab exhibited a safety profile comparable to secukinumab, with mostly mild to moderate adverse events, and a notable incidence of manageable Candida infections in the sonelokimab group, indicating it is a safe treatment option for psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IL17A/F nanobody sonelokimab in patients with plaque psoriasis: a multicentre, randomised, placebo-controlled, phase 2b study. Papp, KA., Weinberg, MA., Morris, A., et al.[2022]

Ixekizumab, an anti-interleukin 17A monoclonal antibody, was well tolerated in patients with rheumatoid arthritis over a 64-week period, with 87% of biologic-naive and 62% of TNF-IR patients completing the study.

Clinical improvements in rheumatoid arthritis symptoms, measured by various scales, were maintained or improved from Week 16 to Week 64, indicating the long-term efficacy of ixekizumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Open-label Subcutaneous Ixekizumab Treatment for 48 Weeks in a Phase II Study in Biologic-naive and TNF-IR Patients with Rheumatoid Arthritis. Genovese, MC., Braun, DK., Erickson, JS., et al.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dual inhibition of IL-17A and IL-17F in psoriatic disease. [2021]

2. England pubmed.ncbi.nlm.nih.gov

IL17A/F nanobody sonelokimab in patients with plaque psoriasis: a multicentre, randomised, placebo-controlled, phase 2b study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Improvements in psoriasis within different body regions vary over time following treatment with ixekizumab. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A multicenter, randomized, double-blinded, placebo-controlled, dose-ranging study evaluating the efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Open-label Subcutaneous Ixekizumab Treatment for 48 Weeks in a Phase II Study in Biologic-naive and TNF-IR Patients with Rheumatoid Arthritis. [2017]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Generation and characterization of ixekizumab, a humanized monoclonal antibody that neutralizes interleukin-17A. [2022]