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Monoclonal Antibodies

Subcutaneous Amlitelimab for Hidradenitis Suppurativa

Phase 2

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), 1 of which must be Hurley Stage II or Hurley Stage III.

Participants with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 up to week 116

Awards & highlights

Study Summary

This trial will assess the efficacy, safety, and drug concentration of a subcutaneous injection of amlitelimab compared to placebo in people aged 18-70 with moderate to severe hidradenitis suppurativa. It will last up to 116 weeks, with up to 6 in-clinic visits in the double-blind period and 8-12 in the open-label extension.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects of Amlitelimab are not listed here, common ones may include reactions at the injection site, flu-like symptoms, headaches, and possible immune system-related effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to week 116

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 up to week 116

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to week 116 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The clinical response as measured by the percentage of participants achieving HiSCR50 at Week 16

Secondary outcome measures

Absolute change from baseline in AN count at Week 16

Change from Baseline in the total Hidradenitis Suppurativa Quality of Life (HiSQOL) score at Week 16

Change in absolute score from Baseline in IHS4 at Week 16

+14 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AmlitelimabExperimental Treatment1 Intervention

Subcutaneous injection (SC) as per protocol.

Group II: PlaceboPlacebo Group1 Intervention

Subcutaneous injection as per protocol.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,896 Total Patients Enrolled

2 Trials studying Hidradenitis Suppurativa

213 Patients Enrolled for Hidradenitis Suppurativa

Clinical Sciences & OperationsStudy DirectorSanofi

862 Previous Clinical Trials

2,019,754 Total Patients Enrolled

1 Trials studying Hidradenitis Suppurativa

114 Patients Enrolled for Hidradenitis Suppurativa

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have been enrolled in the experiment thus far?

"Affirmative. Information gathered from clinicaltrials.gov reveals that this scientific trial, which was initially listed on November 1st 2023, is actively searching for participants. Approximately 84 individuals need to be recruited across 2 distinct medical centres."

Answered by AI

Could you elucidate what risks are associated with Amlitelimab usage?

"Our team at Power assigned Amlitelimab a safety rating of 2 due to Phase 2 trial data that indicates the existence of some evidence for its safety, yet no efficacy findings."

Answered by AI

Does this research program include individuals aged 40 and over?

"According to the requirements of this trial, participants must be between 18 and 70 years old. There are 3 studies that accept those under 18 and 34 for individuals over 65."

Answered by AI

Is this opportunity to become a participant in the trial still available?

"Data from clinicaltrials.gov shows that this research initiative, which was first shared to the public on November 1st 2023, is presently recruiting participants. The trial's most recent update occurred in December 3rd of the same year."

Answered by AI

What type of individuals should be recruited for this experiment?

"This medical experiment is seeking 84 individuals, aged 18 to 70 years old who suffer from hidradenitis suppurativa. Interested patients must have HS lesions present in at least two areas of the body (e.g., left and right axilla; or left axilla and inguino-crural fold). Furthermore, they should have had an inadequate response to oral antibiotic treatment, a history of signs & symptoms consistent with HS for one year prior to baseline assessment, and be over the age of majority if older than eighteen."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

2023. "Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06118099.

All > Hidradenitis Suppurativa