Subcutaneous Amlitelimab for Hidradenitis Suppurativa

Recruiting at 41 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must be taking: Oral antibiotics

Disqualifiers: Inflammatory conditions, Active skin disease, others

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

Compensation: Varies

Number of Visits: 17

90 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does the drug Amlitelimab differ from other treatments for hidradenitis suppurativa?

Amlitelimab is a novel treatment for hidradenitis suppurativa that works differently from existing options like adalimumab, which is a tumor necrosis factor-alpha blocker. While adalimumab is the only approved biologic for this condition, Amlitelimab offers a new approach, potentially targeting different pathways involved in the disease. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a parallel, Phase 2, 2-arm, double-blind, randomized, multicenter, multinational, placebo-controlled study to evaluate efficacy, safety, pharmacokinetics (PK), and biological effects of treatment of subcutaneous injection of amlitelimab compared with placebo in male and female participants aged 18 to 70 years with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to measure standardized clinician reported and participant-reported outcomes (ClinRO and PRO), safety, and drug concentration. An optional long-term extension (LTE) period will assess chronic safety and efficacy over an additional 80 weeks of amlitelimab treatment. Study details include: * The study duration will be up to 116 weeks, including a 4-week Screening period, a 16-week double-blind treatment period (DBT), an optional 80-week LTE period and a 16-week post-treatment follow-up period. * All participants who complete the 16-week DBT period will be offered entry into an optional LTE. * Participants who do not wish to enter the optional LTE period or who stop treatment prior to Week 16 (Visit 6) or stop investigational medicinal product (IMP) administration prior to completing the LTE period will proceed into the 16-week post-treatment follow-up period. * The number of planned in clinic visits will be up to six during the DBT period with an additional nine during the LTE period, plus one post-treatment follow-up end-of-study visit. Up to 11 optional in clinic visits are allowed for participants who do not wish to self-administer IMP between scheduled in clinic visits during the LTE period.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

Adults aged 18 to 70 with moderate to severe hidradenitis suppurativa (HS) who have lesions in at least two areas and haven't responded well to oral antibiotics can join this study. They should have had HS symptoms for at least a year.

Inclusion Criteria

I have HS lesions in at least 2 different body areas, with one being moderate or severe.

I have had symptoms of HS for at least 1 year.

I tried an oral antibiotic for HS, but it didn't work.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Double-blind Treatment

Participants receive subcutaneous injections of amlitelimab or placebo for 16 weeks

16 weeks

Up to 6 visits (in-person)

Post-treatment Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

1 visit (in-person)

Long-term Extension (optional)

Participants may opt into continuation of amlitelimab treatment for chronic safety and efficacy assessment

80 weeks

Up to 9 visits (in-person), with up to 11 optional visits

Treatment Details

Interventions

• Amlitelimab

Trial Overview The trial is testing Amlitelimab, given by injection, against a placebo in people with HS. It's double-blind, meaning neither the participants nor the researchers know who gets the real drug or placebo during the initial phase.

Participant Groups

Group I: Amlitelimab Experimental Treatment 1 Intervention

Subcutaneous injection (SC) as per protocol.

Group II: Placebo Placebo Group 1 Intervention

Subcutaneous injection as per protocol.

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Findings from Research

Adalimumab, when administered weekly, significantly improves clinical responses and quality of life in patients with moderate-to-severe hidradenitis suppurativa (HS), with a number-needed-to-treat (NNT) of 5 for clinical response and 10 for quality of life improvements.

The study, which included 1014 patients across five randomized controlled trials, found that while weekly dosing was more effective, bi-weekly dosing only showed improvement in disease severity without significant differences in adverse events compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of adalimumab in hidradenitis suppurativa: A systematic review and meta-analysis of randomized controlled trials. Lu, JW., Huang, YW., Chen, TL.[2023]

Adalimumab and infliximab are the most studied treatments for moderate to severe hidradenitis suppurativa (HS), with clinical trials showing their efficacy, while other agents like anakinra and ustekinumab also demonstrate promise.

Adalimumab is currently the only biologic approved by the FDA for HS, and most treatments have a good safety profile, although infections are the most common side effect reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of immunomodulatory therapies for hidradenitis suppurativa. Lim, SYD., Oon, HH.[2020]

Adalimumab is the only officially approved treatment for moderate-to-severe hidradenitis suppurativa (HS) and has shown a cumulative response rate of 58% in case reports involving 42 patients.

In phase III trials (PIONEER studies I and II), adalimumab demonstrated significantly higher efficacy compared to placebo at week 12, with adverse events being similar to those experienced by placebo patients, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on adalimumab in the treatment of active moderate-to-severe hidradenitis suppurativa. Fotiadou, C., Vakirlis, E., Ioannides, D.[2020]

In a review of 12 randomized controlled trials involving 2915 patients, adalimumab and bimekizumab were found to be effective treatments for moderate-to-severe hidradenitis suppurativa, showing significant improvement in clinical response compared to placebo at 12-16 weeks.

All evaluated biologics, including adalimumab, bimekizumab, and secukinumab, demonstrated similar safety profiles with no increased risk of adverse effects compared to placebo, making them viable options for patients with refractory hidradenitis suppurativa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Biologics and Small Molecules for Moderate-to-Severe Hidradenitis Suppurativa: A Systematic Review and Network Meta-Analysis. Tsai, YC., Hung, CY., Tsai, TF.[2023]

References

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

Efficacy and safety of adalimumab in hidradenitis suppurativa: A systematic review and meta-analysis of randomized controlled trials. [2023]

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

Systematic review of immunomodulatory therapies for hidradenitis suppurativa. [2020]

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

Spotlight on adalimumab in the treatment of active moderate-to-severe hidradenitis suppurativa. [2020]

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

Adalimumab: A Review in Hidradenitis Suppurativa. [2017]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Biologics and Small Molecules for Moderate-to-Severe Hidradenitis Suppurativa: A Systematic Review and Network Meta-Analysis. [2023]