A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata
- 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 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 166
-
Definitive diagnosis of AA of more than 6 months.
-
Diagnosis of severe AA, as determined by all of the following:
- Hair loss affecting ≥50% of the scalp, as measured by Severity of Alopecia Tool (SALT) at both screening and baseline visits.
- 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.
- 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.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amlitelimab dose group 1 Amlitelimab Subcutaneous injection as per protocol Placebo Placebo Subcutaneous injection as per protocol Amlitelimab dose group 2 Amlitelimab Subcutaneous injection as per protocol
- Primary Outcome Measures
Name Time Method Change from baseline in Severity of Alopecia Tool (SALT) score at Week 36 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).
- Secondary Outcome Measures
Name Time Method Change from the baseline in SALT score at Week 24 (key secondary) Baseline 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).
Proportion of participants achieving a SALT score ≤20 at Weeks 24 and 36 Week 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 ≤20 Up 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 36 Week 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 ≤10 Up 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 SALT50 at Weeks 24 and 36 Week 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.
Proportion of participants achieving a SALT75 at Weeks 24 and 36 Week 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 a SALT90 at Weeks 24 and 36 Week 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 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 36 Week 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 36 Week 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.
Mean changes from baseline in SKINDEX-16AA at Weeks 24 and 36 Baseline 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 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 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 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
Trial Locations
- Locations (73)
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 : 3800001
🇮🇹Bologna, Italy
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
UC Irvine Healthcare - Gottschalk Medical Plaza- Site Number : 8400007
🇺🇸Irvine, 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 : 7240010
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240007
🇪🇸Pozuelo de Alarcón, Madrid, Spain
Investigational Site Number : 7240004
🇪🇸Alicante, Spain
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
Investigational Site Number : 8260005
🇬🇧Dundee, United Kingdom
Investigational Site Number : 8260007
🇬🇧London, United Kingdom
Investigational Site Number : 8260001
🇬🇧London, United Kingdom