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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 week 16

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.
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.
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.
Select...
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 weeks
Treatment ~ Varies
Follow Up ~week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The clinical response as measured by the percentage of participants achieving HiSCR50 at Week 16
Secondary study objectives
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
+10 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.

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,209 Previous Clinical Trials
4,039,683 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
876 Previous Clinical Trials
2,021,670 Total Patients Enrolled
~16 spots leftby Mar 2025
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