Clinical trial NCT06444451: A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Alopecia Areata
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-06-05
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Severity of Alopecia Tool (SALT) score at Week 36
timeFrame: Baseline to Week 36
Secondary outcomes:
measure: Change from the baseline in SALT score at Week 24 (key secondary)
timeFrame: Baseline to Week 24
measure: Proportion of participants achieving a SALT score ≤20 at Weeks 24 and 36
timeFrame: Week 24 and 36
measure: Time to SALT score ≤20
timeFrame: Up to Week 36
measure: Proportion of participants achieving a SALT score ≤10 at Weeks 24 and 36
timeFrame: Week 24 and 36
measure: Time to SALT score ≤10
timeFrame: Up to Week 36
measure: Proportion of participants achieving a SALT50 at Weeks 24 and 36
timeFrame: Week 24 and 36
measure: Proportion of participants achieving a SALT75 at Weeks 24 and 36
timeFrame: Week 24 and36
measure: Proportion of participants achieving a SALT90 at Weeks 24 and 36
timeFrame: Week 24 and 36
measure: 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)
timeFrame: Week 24 and 36
measure: 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)
timeFrame: Week 24 and 36
measure: Proportion of participants achieving a PGI-C response defined as a score of "moderately improved" or "greatly improved" at Weeks 24 and 36
timeFrame: Week 24 and 36
measure: Proportion of participants achieving a PGI-S response defined as a score of "mild" or "none" at Weeks 24 and 36
timeFrame: Week 24 and 36
measure: Mean changes from baseline in SKINDEX-16AA at Weeks 24 and 36
timeFrame: Baseline to Week 24 and 36
measure: 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)
timeFrame: Week 24 and 36
measure: 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)
timeFrame: Week 24 and 36
measure: 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)
timeFrame: Week 24 and 36
measure: 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)
timeFrame: Up to week 156
measure: Serum amlitelimab concentrations measured at prespecified timepoints
timeFrame: Up to Week 156
measure: Incidence of ADAs of amlitelimab at prespecified timepoints
timeFrame: Up to Week 156
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center- Site Number : 8400018
state: Alabama
city: Fountain Valley
country: United States
facility: First OC Dermatology- Site Number : 8400014
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research- Site Number : 8400008
state: California
city: Irvine
country: United States
facility: UC Irvine Healthcare - Gottschalk Medical Plaza- Site Number : 8400007
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates - Los Angeles- Site Number : 8400015
state: California
city: Miami
country: United States
facility: New Horizon Research Center- Site Number : 8400017
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research- Site Number : 8400010
state: Indiana
city: Clarkston
country: United States
facility: Michigan Center for Research Company- Site Number : 8400016
state: Michigan
city: Omaha
country: United States
facility: Joel Schlessinger, PC- Site Number : 8400021
state: Nebraska
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai- Site Number : 8400003
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research - Charlotte - Park Road- Site Number : 8400013
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic- Site Number : 8400028
state: Ohio
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center- Site Number : 8400027
state: Ohio
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400004
state: Oklahoma
city: Portland
country: United States
facility: Oregon Medical Research Center- Site Number : 8400002
state: Oregon
city: Rapid City
country: United States
facility: Health Concepts- Site Number : 8400001
state: South Dakota
city: San Antonio
country: United States
facility: Progressive Clinical Research - San Antonio- Site Number : 8400019
state: Texas
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320002
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320004
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
city: Sydney
country: Australia
facility: Investigational Site Number : 0360001
state: New South Wales
city: Melbourne
country: Australia
facility: Investigational Site Number : 0360003
state: Victoria
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000001
city: Calgary
country: Canada
facility: Investigational Site Number : 1240005
state: Alberta
city: Calgary
country: Canada
facility: Investigational Site Number : 1240007
state: Alberta
city: Winnipeg
country: Canada
facility: Investigational Site Number : 1240001
state: Manitoba
city: Hamilton
country: Canada
facility: Investigational Site Number : 1240003
state: Ontario
city: Markham
country: Canada
facility: Investigational Site Number : 1240006
state: Ontario
city: Santiago
country: Chile
facility: Investigational Site Number : 1520003
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520001
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520004
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520002
state: Reg Metropolitana De Santiago
city: Chengdu
country: China
facility: Investigational Site Number : 1560022
city: Hangzhou
country: China
facility: Investigational Site Number : 1560006
city: Shanghai
country: China
facility: Investigational Site Number : 1560001
city: Ostrava
country: Czechia
facility: Investigational Site Number : 2032104
city: Praha
country: Czechia
facility: Investigational Site Number : 2030011
city: Praha
country: Czechia
facility: Investigational Site Number : 2030012
city: Brest
country: France
facility: Investigational Site Number : 2500001
city: Nice
country: France
facility: Investigational Site Number : 2500002
city: Paris
country: France
facility: Investigational Site Number : 2500003
city: Rouen
country: France
facility: Investigational Site Number : 2500004
city: Augsburg
country: Germany
facility: Investigational Site Number : 2760006
city: Berlin
country: Germany
facility: Investigational Site Number : 2760008
city: Berlin
country: Germany
facility: Investigational Site Number : 2760007
city: Hamburg
country: Germany
facility: Investigational Site Number : 2760001
city: Münster
country: Germany
facility: Investigational Site Number : 2760003
city: Osnabrück
country: Germany
facility: Investigational Site Number : 2760004
city: Milan
country: Italy
facility: Investigational Site Number : 3800004
state: Milano
city: Naples
country: Italy
facility: Investigational Site Number : 3800003
state: Napoli
city: Rome
country: Italy
facility: Investigational Site Number : 3800002
state: Roma
city: Bologna
country: Italy
facility: Investigational Site Number : 3800001
city: Ebina-shi
country: Japan
facility: Investigational Site Number : 3920003
state: Kanagawa
city: Yokohama-Shi
country: Japan
facility: Investigational Site Number : 3920001
state: Kanagawa
city: Kamiamakusa
country: Japan
facility: Investigational Site Number : 3920002
state: Kumamoto
city: Koto-ku
country: Japan
facility: Investigational Site Number : 3920005
state: Tokyo
city: Fukuoka
country: Japan
facility: Investigational Site Number : 3920004
city: Tokyo
country: Japan
facility: Investigational Site Number : 3920006
city: Yokohama
country: Japan
facility: Investigational Site Number : 3920001
city: Rotterdam
country: Netherlands
facility: Investigational Site Number : 5280004
city: Cluj-napoca
country: Romania
facility: Investigational Site Number : 6420001
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240005
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240010
state: Barcelona [Barcelona]
city: Pozuelo de Alarcón
country: Spain
facility: Investigational Site Number : 7240007
state: Madrid
city: Alicante
country: Spain
facility: Investigational Site Number : 7240004
city: Córdoba
country: Spain
facility: Investigational Site Number : 7240002
city: Madrid
country: Spain
facility: Investigational Site Number : 7240006
city: Madrid
country: Spain
facility: Investigational Site Number : 7240008
city: London
country: United Kingdom
facility: Investigational Site Number : 8260003
state: London, City Of
city: Salford
country: United Kingdom
facility: Investigational Site Number : 8260004
state: Manchester
city: Oxford
country: United Kingdom
facility: Investigational Site Number : 8260006
state: Oxfordshire
city: Dundee
country: United Kingdom
facility: Investigational Site Number : 8260005
city: London
country: United Kingdom
facility: Investigational Site Number : 8260007
city: London
country: United Kingdom
facility: Investigational Site Number : 8260001
Study officials:
References: