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OpenTrials
Terminated

NCT Number: NCT06444451

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo 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).

Why the study stopped: Sponsor decision; the decision is not related to any safety concern
Terminated

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Key information

Conditions

Alopecia Areata Alopecia Hair Diseases Hypotrichosis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site Number : 0320002, Rosario, Santa Fe Province, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

Amlitelimab

Drug

Pharmaceutical form: Injection solution Route of administration: SC injection

Other names: SAR445229

Placebo

Drug

Pharmaceutical form: Injection solution Route of administration: SC injection

Primary outcomes

  1. Change from baseline in Severity of Alopecia Tool (SALT) score at Week 36

    Time frame: 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 outcomes

  1. Change from the baseline in SALT score at Week 24 (key secondary)

    Time frame: 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).

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

    Time frame: 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).

  3. Time to SALT score ≤20

    Time frame: 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).

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

    Time frame: 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).

  5. Time to SALT score ≤10

    Time frame: 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).

  6. Proportion of participants achieving a SALT50 at Weeks 24 and 36

    Time frame: 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.

  7. Proportion of participants achieving a SALT75 at Weeks 24 and 36

    Time frame: 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.

  8. Proportion of participants achieving a SALT90 at Weeks 24 and 36

    Time frame: 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.

  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)

    Time frame: 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

  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)

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  13. Mean changes from baseline in SKINDEX-16AA at Weeks 24 and 36

    Time frame: 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.

  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)

    Time frame: 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).

  15. 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)

    Time frame: 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.

  16. 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)

    Time frame: 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.

  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)

    Time frame: Up to week 156

  18. Serum amlitelimab concentrations measured at prespecified timepoints

    Time frame: Up to Week 156

  19. Incidence of ADAs of amlitelimab at prespecified timepoints

    Time frame: Up to Week 156

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 5, 2024
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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