A study to evaluate the efficacy and safety of subcutaneous amlitelimab monotherapy compared with placebo in adult participants with severe alopecia areata

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Recherche & Developpement

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

18 Sep 2024 → 7 May 2026

Decision date (initial)

2024-08-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Sanofi-Aventis Recherche & Developpement

External identifiers

EU CT number

2024-511225-64-00

WHO UTN

U1111-1295-6359

ClinicalTrials.gov

NCT06444451

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy, Pharmacogenetic

To evaluate the efficacy of amlitelimab compared to placebo in adult participants with AA with 50% or greater scalp hair loss on regrowth of lost hair

Secondary objectives 4

1. To evaluate the efficacy of amlitelimab compared to placebo in adult participants with AA with 50% or greater scalp hair loss on improvement of signs, symptoms, and quality of life
2. To assess safety and tolerability of amlitelimab treatment in participants with AA
3. To characterize the PK profile of amlitelimab administered by SC injection in participants with AA
4. To characterize immunogenicity of amlitelimab administered by SC injection in participants with AA

Conditions and MedDRA coding

Alopecia areata

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Definitive diagnosis of AA of more than 6 months.
2. Diagnosis of severe AA, as determined by all of the following: a) Hair loss affecting ≥50% of the scalp, as measured by Severity of Alopecia Tool (SALT) at both screening and baseline visits. b) 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. c) Stable disease: no evidence of terminal hair regrowth within 6 months (ie, equivalent to less than 10% improvement points spontaneous reduction in SALT 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).
3. 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 EOS.

Exclusion criteria 5

1. Participants that are currently experiencing other forms of alopecia, including but not limited to: androgenetic alopecia, trichotillomania, telogen effluvium, traction alopecia, scarring alopecia.
2. 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
3. Received the specified treatment regimens within the timeframe outlined in the protocol.
4. Prior use of any oral JAKi or the topical JAKi ruxolitinib for more than 24 months, regardless if washout period is respected.
5. Subjects with shaved heads must not enter the study until hair has grown back and SALT score can be reliably administered.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in SALT score at Week 36

Secondary endpoints 19

1. Change from the baseline in SALT score at Week 24 (key secondary)
2. Proportion of participants achieving a SALT score ≤20 at Weeks 24 and 36
3. Time to SALT score ≤20
4. Proportion of participants achieving a SALT score ≤10 at Weeks 24 and 36
5. Time to SALT score ≤10
6. Proportion of participants achieving a SALT50 at Weeks 24 and 36
7. Proportion of participants achieving a SALT75 at Weeks 24 and 36
8. Proportion of participants achieving a SALT90 at Weeks 24 and 36
9. 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)
10. 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)
11. Proportion of participants achieving a PGI-C response defined as a score of “moderately improved” or “greatly improved” at Weeks 24 and 36
12. Proportion of participants achieving a PGI-S response defined as a score of “mild“ or “none” at Weeks 24 and 36
13. Mean changes from baseline in SKINDEX-16AA at Weeks 24 and 36
14. 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)
15. Proportion of participants achieving grade 0 or 1 with ≥2­point improvement from baseline PRO Measure for EB Hair Loss (among participants with PRO Measure for EB Hair Loss ≥2 at Baseline)
16. Proportion of participants achieving grade 0 or 1 with ≥2­point 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)
17. 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)
18. Serum amlitelimab concentrations measured at prespecified timepoints
19. Incidence of ADAs) of amlitelimab at prespecified timepoints

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

Sponsor organisation

Sanofi-Aventis Recherche & Developpement

Address

82 Avenue Raspail

City

Gentilly

Postcode

94250

Country

France

Scientific contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Third parties 14

Locations

8 EU/EEA countries · 29 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 108 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

12 submissions — initial application plus substantial / non-substantial modifications