Subcutaneous Amlitelimab for Hidradenitis Suppurativa

No longer recruiting at 48 trial locations

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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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called amlitelimab to determine its effectiveness for people with moderate to severe hidradenitis suppurativa (HS), a skin condition that causes painful lumps. The study compares amlitelimab injections with a placebo to assess improvements and safety. Participants who have experienced HS symptoms for at least a year and have not found success with antibiotics might be suitable candidates. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

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.

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

Research shows that amlitelimab is generally safe for use. Studies have found that people using amlitelimab for skin conditions like atopic dermatitis (a long-lasting skin issue) mostly experienced only mild side effects. In one study, researchers described the safety of amlitelimab as "unremarkable," indicating no major safety concerns. This suggests that most people did not have serious negative reactions to the treatment.

For those considering joining a trial with amlitelimab, this information might be reassuring. However, this is a Phase 2 trial, meaning the treatment is still being tested to ensure its safety and effectiveness for everyone. Participants should always consult their doctor to understand the benefits and any possible risks. ^{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 often include antibiotics, anti-inflammatory drugs, or biologics like TNF inhibitors, Amlitelimab offers a fresh approach by targeting the OX40-ligand pathway. This pathway plays a crucial role in the immune response, and by modulating it, Amlitelimab aims to reduce inflammation and help prevent the painful flare-ups characteristic of the condition. Researchers are excited about Amlitelimab because this targeted mechanism could provide more precise control over the disease, potentially leading to fewer side effects and improved quality of life for patients. Additionally, its subcutaneous administration makes it a convenient option compared to some existing therapies that require more invasive administration methods.

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

Research shows that amlitelimab, a monoclonal antibody, may help treat skin conditions like atopic dermatitis, a form of eczema. In earlier studies, patients experienced symptom improvements even after stopping the medicine. This suggests amlitelimab might manage inflammation-related conditions. In this trial, participants will receive either amlitelimab or a placebo to evaluate its effectiveness for hidradenitis suppurativa (HS). While researchers continue to study its use for HS, its ability to target inflammation offers hope for potential effectiveness. Early results in other conditions suggest it might provide relief for people with moderate to severe HS. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

Citations

1. sanofi.com sanofi.com/assets/dotcom/pressreleases/2024/2024-03-11-06-00-00-2843456-en.pdf

New Phase 2b results for amlitelimab support potential for ... Late-breaking data at AAD show sustained off-drug improvements of AD signs and symptoms with amlitelimab for 28 weeks.

2. jaad.org jaad.org/article/S0190-9622(22)01573-0/fulltext

34312 Treatment with amlitelimab (KY1005, SAR445229) In a phase 2a trial amlitelimab, a human nondepleting monoclonal anti-OX40Ligand antibody, was effective in treating patients with moderate to severe AD.

3. sanofistudies.com sanofistudies.com/cwout/CW-V9DEXS//us/en/listing/312882/proof-of-concept-study-evaluating-subcutaneous/

Study on Investigational Medication for Hidradenitis ... This study investigates the effects of an investigational medication compared to a placebo in people with moderate to severe hidradenitis suppurativa (HS).

4. sanofistudies.com sanofistudies.com/cwout/CW-V9DEXS//it/it/listing/312882/proof-of-concept-study-evaluating-subcutaneous/

Proof-of-concept Study Evaluating Subcutaneous ... The purpose of this study is to measure standardized clinician reported and participant-reported outcomes (ClinRO and PRO), safety, and drug ...

5. sanofi.com sanofi.com/en/our-science/clinical-trials-and-results/oceana-clinical-program-investigating-amlitelimab-in-atopic-dermatitis

OCEANA Clinical Program This program aims to evaluate the efficacy and safety of a potential therapy, amlitelimab, in patients with moderate to severe atopic dermatitis.

6. trial.medpath.com trial.medpath.com/clinical-trial/568bc781f9fc081b/nct06118099-amlitelimab-hidradenitis-suppurativa

Proof-of-concept Study Evaluating Subcutaneous Amlitelimab ... The purpose of this study is to measure standardized clinician reported and participant-reported outcomes (ClinRO and PRO), safety, and drug concentration. An ...