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

A Phase 2, Randomized, Double-blind, Placebo--controlled, Parallel Group, 3-arm, Multinational, Multicenter, Proof-of-concept Study to Evaluate the Efficacy and Safety of Amlitelimab Monotherapy by Subcutaneous Injection in Adult Participants With Severe Alopecia Areata

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 double-blind treatment period, all participants will have the option to enter the open-label extension (OLE) period.

The study duration will be up to 160 weeks for participants entering the OLE period including a 2-to-4-week screening, a 36-week randomized double-blind period, an optional OLE period (104 weeks) and a 16-week safety follow-up. The open-label extension period is optional and open to all participants who have completed the double-blind treatment period.

The total number of visits will be up to 38 visits (or 12 visits for those not entering the OLE study).

Study Overview

• Status: Active, not recruiting
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Amlitelimab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1055
    • Investigational Site Number : 0320004
  • Buenos Aires, Argentina, 1061
    • Investigational Site Number : 0320001
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, 2000
      • Investigational Site Number : 0320002
• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2010
      • Investigational Site Number : 0360001
  • Victoria
    • Melbourne, Victoria, Australia, 3002
      • Investigational Site Number : 0360003
• Bulgaria
  • Sofia, Bulgaria, 1612
    • Investigational Site Number : 1000001
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Investigational Site Number : 1240005
    • Calgary, Alberta, Canada, T2W 4X9
      • Investigational Site Number : 1240007
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Investigational Site Number : 1240001
  • Ontario
    • Hamilton, Ontario, Canada, L8L 3C3
      • Investigational Site Number : 1240003
    • Markham, Ontario, Canada, L3P 1X2
      • Investigational Site Number : 1240006
• Chile
  • Reg Metropolitana de Santiago
    • Santiago, Reg Metropolitana de Santiago, Chile, 7580206
      • Investigational Site Number : 1520003
    • Santiago, Reg Metropolitana de Santiago, Chile, 7640881
      • Investigational Site Number : 1520001
    • Santiago, Reg Metropolitana de Santiago, Chile, 8420383
      • Investigational Site Number : 1520002
    • Santiago, Reg Metropolitana de Santiago, Chile, 8380465
      • Investigational Site Number : 1520004
• China
  • Chengdu, China, 610041
    • Investigational Site Number : 1560022
  • Hangzhou, China, 310009
    • Investigational Site Number : 1560006
  • Shanghai, China, 200040
    • Investigational Site Number : 1560001
• Czechia
  • Ostrava, Czechia, 702 00
    • Investigational Site Number : 2032104
  • Prague, Czechia, 150 00
    • Investigational Site Number : 2030011
  • Prague, Czechia, 158 00
    • Investigational Site Number : 2030012
• France
  • Brest, France, 29200
    • Investigational Site Number : 2500001
  • Nice, France, 06202
    • Investigational Site Number : 2500002
  • Paris, France, 75010
    • Investigational Site Number : 2500003
  • Rouen, France, 76031
    • Investigational Site Number : 2500004
• Germany
  • Augsburg, Germany, 86150
    • Investigational Site Number : 2760006
  • Berlin, Germany, 10117
    • Investigational Site Number : 2760008
  • Berlin, Germany, 10629
    • Investigational Site Number : 2760007
  • Hamburg, Germany, 20095
    • Investigational Site Number : 2760001
  • Münster, Germany, 48149
    • Investigational Site Number : 2760003
  • Osnabrück, Germany, 49074
    • Investigational Site Number : 2760004
• Italy
  • Bologna, Italy, 40138
    • Investigational Site Number : 3800001
  • Milano
    • Milan, Milano, Italy, 20132
      • Investigational Site Number : 3800004
  • Napoli
    • Naples, Napoli, Italy, 80131
      • Investigational Site Number : 3800003
  • Roma
    • Rome, Roma, Italy, 00168
      • Investigational Site Number : 3800002
• Japan
  • Fukuoka, Japan, 814-0171
    • Investigational Site Number : 3920004
  • Tokyo, Japan, 160-0023
    • Investigational Site Number : 3920006
  • Yokohama, Japan, 221-0825
    • Investigational Site Number : 3920001
  • Kanagawa
    • Ebina-shi, Kanagawa, Japan, 243-0432
      • Investigational Site Number : 3920003
    • Yokohama, Kanagawa, Japan, 221-0825
      • Investigational Site Number : 3920001
  • Kumamoto
    • Kamiamakusa, Kumamoto, Japan, 861-3106
      • Investigational Site Number : 3920002
  • Tokyo
    • Koto-ku, Tokyo, Japan, 136-0075
      • Investigational Site Number : 3920005
• Netherlands
  • Rotterdam, Netherlands, 3015 CE
    • Investigational Site Number : 5280004
• Romania
  • Cluj-Napoca, Romania, 400006
    • Investigational Site Number : 6420001
• Spain
  • Alicante, Spain, 03010
    • Investigational Site Number : 7240004
  • Córdoba, Spain, 14004
    • Investigational Site Number : 7240002
  • Madrid, Spain, 28031
    • Investigational Site Number : 7240006
  • Madrid, Spain, 28040
    • Investigational Site Number : 7240008
  • Barcelona [Barcelona]
    • Barcelona, Barcelona [Barcelona], Spain, 08035
      • Investigational Site Number : 7240005
    • Barcelona, Barcelona [Barcelona], Spain, 08036
      • Investigational Site Number : 7240010
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Investigational Site Number : 7240007
• United Kingdom
  • Dundee, United Kingdom, DD1 9SY
    • Investigational Site Number : 8260005
  • London, United Kingdom, SE1 9RT
    • Investigational Site Number : 8260007
  • London, United Kingdom, SE5 9RL
    • Investigational Site Number : 8260001
  • London, City of
    • London, London, City of, United Kingdom, SW10 9NH
      • Investigational Site Number : 8260003
  • Manchester
    • Salford, Manchester, United Kingdom, M6 8HD
      • Investigational Site Number : 8260004
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7LE
      • Investigational Site Number : 8260006
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Dermatology Center- Site Number : 8400018
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology- Site Number : 8400014
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research- Site Number : 8400008
    • Irvine, California, United States, 92697
      • UC Irvine Healthcare - Gottschalk Medical Plaza- Site Number : 8400007
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates - Los Angeles- Site Number : 8400015
  • Florida
    • Miami, Florida, United States, 33165
      • New Horizon Research Center- Site Number : 8400017
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Research- Site Number : 8400010
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Michigan Center for Research Company- Site Number : 8400016
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Joel Schlessinger, PC- Site Number : 8400021
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai- Site Number : 8400003
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • DJL Clinical Research - Charlotte - Park Road- Site Number : 8400013
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic- Site Number : 8400028
    • Mayfield Heights, Ohio, United States, 44124
      • Apex Clinical Research Center- Site Number : 8400027
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400004
  • Oregon
    • Portland, Oregon, United States, 97201
      • Oregon Medical Research Center- Site Number : 8400002
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts- Site Number : 8400001
  • Texas
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Research - San Antonio- Site Number : 8400019

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 severe hair loss of less than 8 years. Participants with a history of AA of more than 8 years who have observed episodes of terminal hair regrowth over their scalp ("moving patches" spontaneously or following treatment) in the past 8 years can be included.
  3. Stable disease: no evidence of terminal hair regrowth within 6 months (less than 10% improvement over the past 6 months). (guidance: if participant reports to have quite a bit more hair than 6 months prior, then patient cannot be included).
• 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.

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, which in the opinion of the Investigator would interfere with evaluations of the IMP effect on AA due to scalp inflammation, 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.
• 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 24 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Subcutaneous injection as per protocol	Drug: Placebo; Pharmaceutical form: Injection solution Route of administration: SC injection
Experimental: Amlitelimab dose group 1; Subcutaneous injection as per protocol	Drug: Amlitelimab; Pharmaceutical form: Injection solution Route of administration: SC injection; Other Names: SAR445229
Experimental: Amlitelimab dose group 2; Subcutaneous injection as per protocol	Drug: Amlitelimab; Pharmaceutical form: Injection solution Route of administration: SC injection; Other Names: SAR445229

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Severity of Alopecia Tool (SALT) score at 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).	Baseline to Week 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving a SALT score ≤20 at Weeks 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).	Week 24 and 36
Time to SALT score ≤20	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).	Up to Week 36
Proportion of participants achieving a SALT score ≤10 at Weeks 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).	Week 24 and 36
Time to SALT score ≤10	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).	Up to Week 36
Proportion of participants achieving a SALT50 at Weeks 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.	Week 24 and 36
Proportion of participants achieving a SALT75 at Weeks 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). SALT75 is 75% reduction from baseline in SALT score.	Week 24 and36
Proportion of participants achieving a SALT90 at Weeks 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.	Week 24 and 36
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)	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	Week 24 and 36
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)	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.	Week 24 and 36
Proportion of participants achieving a PGI-C response defined as a score of "moderately improved" or "greatly improved" at Weeks 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.	Week 24 and 36
Proportion of participants achieving a PGI-S response defined as a score of "mild" or "none" at Weeks 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.	Week 24 and 36
Mean changes from baseline in SKINDEX-16AA at Weeks 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.	Baseline to Week 24 and 36
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)	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).	Week 24 and 36
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)	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.	Week 24 and 36
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)	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.	Week 24 and 36
Change from the baseline in SALT score at Week 24 (key secondary)	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).	Baseline to Week 24
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 156
Serum amlitelimab concentrations measured at prespecified timepoints		Up to Week 156
Incidence of ADAs of amlitelimab at prespecified timepoints		Up to Week 156

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

Helpful Links

• DRI18180 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2024
• Primary Completion (Actual): September 24, 2025
• Study Completion (Estimated): January 5, 2028

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Estimated): October 24, 2025
• Last Update Submitted That Met QC Criteria: October 22, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Alopecia; Hypotrichosis; Hair Diseases; Skin and Connective Tissue Diseases; Alopecia Areata
• Other Study ID Numbers: DRI18180; 2024-511225-64 (Registry Identifier: CTIS); U1111-1295-6359 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No