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

Alopecia Areata Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06444451
• Other study ID #: DRI18180
• Secondary ID: 2024-511225-64U1
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 24, 2024
• Est. completion date: February 19, 2026

Study information

• Verified date: May 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free for US & Canada)
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 treatment period, all participants will have the option to enter a separate study, the open-label extension (OLE) study, once eligibility is confirmed.

The study duration will be up to 56 weeks for participants not entering the OLE including a 2-to-4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the OLE, the DRI18180 study duration will be up to 40 weeks, including a 2-to-4-week screening, a 36-week randomized double-blind period The total number of visits will be up to 12 visits (or 11 visits for those entering the OLE study).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 19, 2026
• Est. primary completion date: February 19, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 hair loss of less than 8 years.

3. No evidence of terminal hair regrowth within 6 months (ie, equivalent to less than 10 points spontaneous reduction in SALT over the past 6 months).

Note: participants with severe AA for =8 years may be enrolled if episodes of regrowth are observed in the affected areas over the past 8 years, spontaneously and/or under treatment.

• 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, 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 that in opinion of the Investigator would interfere with evaluations of the investigational medicinal product (IMP) effect on AA due to scalp inflammation.

• 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 12 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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Amlitelimab
Pharmaceutical form: Injection solution Route of administration: SC injection
• Placebo
Pharmaceutical form: Injection solution Route of administration: SC injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Severity of Alopecia Tool (SALT) score at 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).	Baseline to Week 24
Secondary	Change from the baseline in SALT score at Week 36 (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 36
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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 52
Secondary	Serum amlitelimab concentrations measured at prespecified timepoints		Up to Week 52
Secondary	Incidence of ADAs) of amlitelimab at prespecified timepoints		Up to Week 52