Sonelokimab for Hidradenitis Suppurativa

No longer recruiting at 70 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a new treatment, sonelokimab (an anti-inflammatory drug), for individuals with moderate to severe hidradenitis suppurativa, a painful skin condition with lumps and abscesses. Participants will receive either sonelokimab, a placebo (inactive substance), or adalimumab (a current treatment) to compare their effectiveness. This trial may suit those who have experienced hidradenitis suppurativa symptoms for at least six months and have not responded well to antibiotics. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that sonelokimab, a treatment being tested for hidradenitis suppurativa, has been safe in earlier studies. One study found that participants tolerated multiple doses of sonelokimab administered as an injection under the skin. Improvements in conditions like psoriasis suggest potential benefits. Although specific side effects weren't detailed, a "favorable safety profile" indicates that serious side effects were uncommon in these tests. Overall, current data suggests sonelokimab is relatively safe for humans. ^{1 2 3 4 5}

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

Sonelokimab is unique because it targets the IL-17A and IL-17F cytokines, which play a significant role in the inflammatory process of Hidradenitis Suppurativa (HS). Current standard treatments, like adalimumab, focus on blocking TNF-alpha, another inflammation pathway. Researchers are excited about sonelokimab because its dual-action mechanism could potentially offer more effective relief by tackling the inflammation from a different angle. This novel approach might provide a new hope for patients who do not fully respond to existing therapies.

What evidence suggests that this trial's treatments could be effective for hidradenitis suppurativa?

Research has shown that sonelokimab, a new treatment known as a nanobody, targets specific proteins that cause inflammation. One study showed promising results for people with moderate to severe psoriasis, a skin condition similar to hidradenitis suppurativa. Nearly 60% of these patients achieved completely clear skin after 24 weeks. This trial will evaluate sonelokimab in different dosage regimens to assess its potential to reduce symptoms in inflammatory conditions like hidradenitis suppurativa. Although more research is needed, these early results offer hope for its potential effectiveness. ^{3 6 7 8 9}

Who Is on the Research Team?

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

Principal Investigator

MoonLake Immunotherapeutics AG

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Sonelokimab

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1.

trial.medpath.com

trial.medpath.com/news/48d30c462ec9a9a8/moonlake-immunotherapeutics-advances-sonelokimab-through-phase-3-trials-for-multiple-inflammatory-conditions

MoonLake Immunotherapeutics Advances Sonelokimab ...

MoonLake Immunotherapeutics is advancing Sonelokimab, a novel Nanobody® targeting IL-17A/A, A/F, and F/F dimers, through multiple Phase 3 trials for ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0190962219305006

A randomized, double-blind, placebo-controlled phase 1 ...

The study evaluated M1095 for psoriasis, showing dose-dependent improvements and a favorable safety profile, with the highest dose showing the greatest ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30926369/

A randomized, double-blind, placebo-controlled phase 1 ...

Conclusion: Multiple subcutaneous doses of M1095 showed a favorable safety profile with dose-dependent improvements in psoriasis. Keywords: ALX-0761; M1095; ...

4.

access.portico.org

access.portico.org/Portico/show?viewFile=pdf&auId=pjbc7jrsxx6

Sonelokimab. Interleukin-17A and -F nanobody, Treatment of ...

Sonelokimab is a novel anti-IL-17A/F nanobody, a tetravalent bispecific camelid single-domain antibody, used for treatment of moderate to severe psoriasis.

5.

ir.moonlaketx.com

ir.moonlaketx.com/news-releases/news-release-details/moonlake-immunotherapeutics-announces-publication-lancet

MoonLake Immunotherapeutics announces publication in ...

Sonelokimab showed almost 6 out of 10 patients with moderate to severe psoriasis achieved total skin clearance (PASI 100) at 24 weeks, with ...

6.

abmole.com

abmole.com/literature/sonelokimab-msds.html?srsltid=AfmBOorxtXhGsM5Wnxb4uCpno7BPcS4vLDl98XjlKK6b5jc3cgn_h0X1

Material Safety Data Sheet of Sonelokimab

Material Safety Data Sheet of Sonelokimab contains identification of substance and details of the supplier of the safety data sheet.

7.

medchemexpress.com

medchemexpress.com/sonelokimab.html?srsltid=AfmBOopjwR7xFWq23X5vooNeaZP1_3wmtFg2p1pDp3xZpgxk5nhuBUD2

Sonelokimab (ALX 0761) | Anti-IL-17A/F Antibody

Sonelokimab (ALX 0761) is a trivalent bispecific nanobody composed of camel derived humanized IL-17F antibodies, IL-17A/F antibodies, and serum albumin VHH ...

8.

file.medchemexpress.com

file.medchemexpress.com/batch_PDF/HY-P99397/Sonelokimab-SDS-MedChemExpress.pdf

Safety Data Sheet

Avoid breathing vapors, mist, dust or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Refer to protective measures listed in ...

9.

precision.fda.gov

precision.fda.gov/ginas/app/ui/substances/7d9c6fb7-bef8-436b-a041-d63fdd279f1a

SONELOKIMAB

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