MedPath

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata

Phase 2
Recruiting
Conditions
Alopecia Areata
Interventions
Drug: Amlitelimab
Drug: Placebo
Registration Number
NCT06444451
Lead Sponsor
Sanofi
Brief Summary

This is a parallel, Phase 2 multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study to investigate the efficacy and safety of subcutaneous (SC) injections of amlitelimab treatment as monotherapy in participants aged 18 years and older with severe alopecia areata (AA). At the end of the treatment period, all participants will have the option to enter a separate study, the open-label extension (OLE) study, once eligibility is confirmed.

The study duration will be up to 56 weeks for participants not entering the OLE including a 2-to-4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the OLE, the DRI18180 study duration will be up to 40 weeks, including a 2-to-4-week screening, a 36-week randomized double-blind period The total number of visits will be up to 12 visits (or 11 visits for those entering the OLE study).

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
150
Inclusion Criteria
  • Definitive diagnosis of AA of more than 6 months.

  • Diagnosis of severe AA, as determined by all of the following:

    1. Hair loss affecting ≥50% of the scalp, as measured by Severity of Alopecia Tool (SALT) at both screening and baseline visits.

    2. Current episode of hair loss of less than 8 years.

    3. No evidence of terminal hair regrowth within 6 months (ie, equivalent to less than 10 points spontaneous reduction in SALT over the past 6 months).

      Note: participants with severe AA for ≥8 years may be enrolled if episodes of regrowth are observed in the affected areas over the past 8 years, spontaneously and/or under treatment.

  • Willingness in maintaining a consistent hair style and hair care, including hair products, and to refrain from weaves, extensions, adhesive wigs, other than banded perimeter devices, refrain from shaving of scalp hair for 2 weeks prior to each study visit from baseline to the end of study.

Read More
Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

  • Participants that are currently experiencing other forms of alopecia, including but not limited to: androgenetic alopecia, trichotillomania, telogen effluvium, traction alopecia, scarring alopecia.
  • Participants currently with any local or systemic active medical conditions, including but not limited to seborrheic dermatitis requiring topical treatment to the scalp, lupus erythematosus, lichen planus, psoriasis, secondary syphilis, tinea capitis, thyroiditis, systemic sclerosis, hair transplants, micropigmentation/tattoo of the scalp that in opinion of the Investigator would interfere with evaluations of the investigational medicinal product (IMP) effect on AA due to scalp inflammation.
  • Received the specified treatment regimens within the timeframe outlined in the protocol.
  • Prior use of any oral JAKi or the topical JAKi ruxolitinib for more than 12 months, regardless if washout period is respected.
  • Participants with shaved heads must not enter the study until hair has grown back and SALT score can be reliably administered.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Amlitelimab dose group 1AmlitelimabSubcutaneous injection as per protocol
Amlitelimab dose group 2AmlitelimabSubcutaneous injection as per protocol
PlaceboPlaceboSubcutaneous injection as per protocol
Primary Outcome Measures
NameTimeMethod
Change from baseline in Severity of Alopecia Tool (SALT) score at Week 24Baseline to Week 24

SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss).

Secondary Outcome Measures
NameTimeMethod
Change from the baseline in SALT score at Week 36 (key secondary)Baseline to Week 36

SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss).

Proportion of participants achieving a SALT score ≤20 at Weeks 24 and 36Week 24 and 36

SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss).

Time to SALT score ≤20Up to Week 36

SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss).

Proportion of participants achieving a SALT score ≤10 at Weeks 24 and 36Week 24 and 36

SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss).

Proportion of participants achieving grade 0 or 1 with ≥2-point improvement from baseline PRO Measure for EL Hair Loss at Weeks 24 and 36 (among participants with PRO Measure for EL Hair Loss ≥2 at Baseline)Week 24 and 36

PRO Measure foe Eyelash Hair Loss™ is a single item, patient-reported NRS measuring eyelash hair loss, ranging from 0 to 3, with 0 = full coverage/no eyelash hair loss and 3 = barely any/no notable eyelash hair.

Proportion of participants achieving a SALT90 at Weeks 24 and 36Week 24 and 36

SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). SALT90 is 90% reduction from baseline in SALT score.

Proportion of participants achieving a SALT50 at Weeks 24 and 36Week 24 and 36

SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). SALT50 is 50% reduction from baseline in SALT score.

Time to SALT score ≤10Up to Week 36

SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss).

Mean changes from baseline in SKINDEX-16AA at Weeks 24 and 36Baseline to Week 24 and 36

Skindex-16 for alopecia areata (SKINDEX-16AA) is a tool used to assess the health-related quality of life in participants with skin disorders. The score ranges from 0 to 100, with higher scores indicating a greater burden of AA on the patient.

Proportion of participants with PRO Scalp Hair Assessment score of 0 to 1 with ≥2-point improvement from baseline (among participants with PRO Scalp Hair Assessment score ≥3 at Baseline)Week 24 and 36

Scalp Hair Assessment patient reported outcome (PRO) is a single item, patient-reported NRS using a 5-point response scale and ranging from 0 to 4, with 0 = no missing hair (0% scalp hair missing) and 4 = nearly all or all missing hair (95- 100% scalp hair missing).

Proportion of participants achieving a SALT75 at Weeks 24 and 36Week 24 and36

SALT is a quantitative Investigator assessment of AA severity scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). SALT75 is 75% reduction from baseline in SALT score.

Proportion of participants achieving ClinRO Measure for eyebrow (EB) Hair Loss 0 or 1 with ≥2-point improvement from baseline at Weeks 24 and 36 (among participants with ClinRO Measure for EB Hair Loss ≥2 at Baseline)Week 24 and 36

ClinRO Measure for EB Hair Loss is a single item, clinician-reported numeric rating scale (NRS) measuring eyebrow hair loss. Scores range from 0 = normal appearance/no eyebrow hair loss to 3 = severe appearance/severe eyebrow hair loss

Proportion of participants achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 with ≥2-point improvement from baseline (among participants with ClinRO Measure for EL Hair Loss ≥2 at Baseline)Week 24 and 36

ClinRO Measure for EL Hair Loss is a single item, clinician-reported numeric rating scale (NRS) measuring eyelash hair loss. Scores range from 0 = normal appearance/no eyelash hair loss to 3 = severe appearance/severe eyelash hair loss.

Proportion of participants achieving a PGI-C response defined as a score of "moderately improved" or "greatly improved" at Weeks 24 and 36Week 24 and 36

The Patient Global Impression of Change (PGI-C) is a questionnaire that asks participants to provide the overall self-assessment of change in their AA overall on a 5-point scale. The PGI-C will be scored from 1 = Much better to 5 = Much worse.

Proportion of participants achieving a PGI-S response defined as a score of "mild" or "none" at Weeks 24 and 36Week 24 and 36

The Patient Global Impression of Severity (PGI-S) is a single item 5-point scale (1 = no symptoms to 5 = very severe symptoms) which asks a participant to assess current severity of AA symptoms.

Proportion of participants achieving grade 0 or 1 with ≥2-point improvement from baseline PRO Measure for EB Hair Loss (among participants with PRO Measure for EB Hair Loss ≥2 at Baseline)Week 24 and 36

PRO Measure for Eyebrow Hair Loss™ is a single item, patient-reported NRS measuring eyebrow hair loss, ranging from 0 to 3, with 0 = full coverage/no eyebrow hair loss and 3 = barely any/no notable eyebrow hair.

Proportion of participants who experienced treatment-emergent adverse events (TEAEs), experienced treatment-emergent serious adverse event (TESAEs) and/or Treatment-Emergent adverse event of special interest (AESIs)Up to week 52
Serum amlitelimab concentrations measured at prespecified timepointsUp to Week 52
Incidence of ADAs) of amlitelimab at prespecified timepointsUp to Week 52

Trial Locations

Locations (73)

Investigational Site Number : 7240002

🇪🇸

Córdoba, Spain

Investigational Site Number : 7240006

🇪🇸

Madrid, Spain

Investigational Site Number : 7240008

🇪🇸

Madrid, Spain

Investigational Site Number : 8260003

🇬🇧

London, London, City Of, United Kingdom

Investigational Site Number : 8260004

🇬🇧

Salford, Manchester, United Kingdom

Investigational Site Number : 8260006

🇬🇧

Oxford, Oxfordshire, United Kingdom

UC Irvine Healthcare - Gottschalk Medical Plaza- Site Number : 8400007

🇺🇸

Irvine, California, United States

Total Skin and Beauty Dermatology Center- Site Number : 8400018

🇺🇸

Birmingham, Alabama, United States

First OC Dermatology- Site Number : 8400014

🇺🇸

Fountain Valley, California, United States

Center for Dermatology Clinical Research- Site Number : 8400008

🇺🇸

Fremont, California, United States

Dermatology Research Associates - Los Angeles- Site Number : 8400015

🇺🇸

Los Angeles, California, United States

New Horizon Research Center- Site Number : 8400017

🇺🇸

Miami, Florida, United States

Dawes Fretzin Clinical Research- Site Number : 8400010

🇺🇸

Indianapolis, Indiana, United States

Michigan Center for Research Company- Site Number : 8400016

🇺🇸

Clarkston, Michigan, United States

Joel Schlessinger, PC- Site Number : 8400021

🇺🇸

Omaha, Nebraska, United States

Icahn School of Medicine at Mount Sinai- Site Number : 8400003

🇺🇸

New York, New York, United States

DJL Clinical Research - Charlotte - Park Road- Site Number : 8400013

🇺🇸

Charlotte, North Carolina, United States

Cleveland Clinic- Site Number : 8400028

🇺🇸

Cleveland, Ohio, United States

Apex Clinical Research Center- Site Number : 8400027

🇺🇸

Mayfield Heights, Ohio, United States

Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400004

🇺🇸

Tulsa, Oklahoma, United States

Oregon Medical Research Center- Site Number : 8400002

🇺🇸

Portland, Oregon, United States

Health Concepts- Site Number : 8400001

🇺🇸

Rapid City, South Dakota, United States

Progressive Clinical Research - San Antonio- Site Number : 8400019

🇺🇸

San Antonio, Texas, United States

Investigational Site Number : 0320002

🇦🇷

Rosario, Santa Fe, Argentina

Investigational Site Number : 0320004

🇦🇷

Buenos Aires, Argentina

Investigational Site Number : 0320001

🇦🇷

Buenos Aires, Argentina

Investigational Site Number : 0360001

🇦🇺

Sydney, New South Wales, Australia

Investigational Site Number : 0360003

🇦🇺

Melbourne, Victoria, Australia

Investigational Site Number : 1000001

🇧🇬

Sofia, Bulgaria

Investigational Site Number : 1240005

🇨🇦

Calgary, Alberta, Canada

Investigational Site Number : 1240007

🇨🇦

Calgary, Alberta, Canada

Investigational Site Number : 1240001

🇨🇦

Winnipeg, Manitoba, Canada

Investigational Site Number : 1240003

🇨🇦

Hamilton, Ontario, Canada

Investigational Site Number : 1240006

🇨🇦

Markham, Ontario, Canada

Investigational Site Number : 1520003

🇨🇱

Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520001

🇨🇱

Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520004

🇨🇱

Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520002

🇨🇱

Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1560022

🇨🇳

Chengdu, China

Investigational Site Number : 1560006

🇨🇳

Hangzhou, China

Investigational Site Number : 1560001

🇨🇳

Shanghai, China

Investigational Site Number : 2032104

🇨🇿

Ostrava, Czechia

Investigational Site Number : 2030011

🇨🇿

Praha, Czechia

Investigational Site Number : 2030012

🇨🇿

Praha, Czechia

Investigational Site Number : 2500001

🇫🇷

Brest, France

Investigational Site Number : 2500002

🇫🇷

Nice, France

Investigational Site Number : 2500003

🇫🇷

Paris, France

Investigational Site Number : 2500004

🇫🇷

Rouen, France

Investigational Site Number : 2760006

🇩🇪

Augsburg, Germany

Investigational Site Number : 2760008

🇩🇪

Berlin, Germany

Investigational Site Number : 2760007

🇩🇪

Berlin, Germany

Investigational Site Number : 2760001

🇩🇪

Hamburg, Germany

Investigational Site Number : 2760003

🇩🇪

Münster, Germany

Investigational Site Number : 2760004

🇩🇪

Osnabrück, Germany

Investigational Site Number : 3800004

🇮🇹

Milan, Milano, Italy

Investigational Site Number : 3800003

🇮🇹

Naples, Napoli, Italy

Investigational Site Number : 3800002

🇮🇹

Rome, Roma, Italy

Investigational Site Number : 3800001

🇮🇹

Bologna, Italy

Investigational Site Number : 3920003

🇯🇵

Ebina-shi, Kanagawa, Japan

Investigational Site Number : 3920001

🇯🇵

Yokohama, Japan

Investigational Site Number : 3920002

🇯🇵

Kamiamakusa, Kumamoto, Japan

Investigational Site Number : 3920005

🇯🇵

Koto-ku, Tokyo, Japan

Investigational Site Number : 3920004

🇯🇵

Fukuoka, Japan

Investigational Site Number : 3920006

🇯🇵

Tokyo, Japan

Investigational Site Number : 5280004

🇳🇱

Rotterdam, Netherlands

Investigational Site Number : 6420001

🇷🇴

Cluj-napoca, Romania

Investigational Site Number : 7240005

🇪🇸

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240010

🇪🇸

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240007

🇪🇸

Pozuelo de Alarcón, Madrid, Spain

Investigational Site Number : 7240004

🇪🇸

Alicante, Spain

Investigational Site Number : 8260005

🇬🇧

Dundee, United Kingdom

Investigational Site Number : 8260007

🇬🇧

London, United Kingdom

Investigational Site Number : 8260001

🇬🇧

London, United Kingdom

© Copyright 2025. All Rights Reserved by MedPath