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
A study to evaluate the efficacy and safety of subcutaneous amlitelimab monotherapy compared with placebo in adult participants with severe alopecia areata
Obara Kentaro
Sanofi K.K.
Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan
+81-3-6301-3670
clinical-trials-jp@sanofi.com
Clinical Study Unit
Sanofi K.K.
Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan
+81-3-6301-3670
clinical-trials-jp@sanofi.com
Not Recruiting
July. 31, 2024
July. 24, 2024
150
Interventional
randomized controlled trial
double blind
placebo control
parallel assignment
treatment purpose
- Definitive diagnosis of alopecia areata (AA) of more than 6 months.
- 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 (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 that in opinion of the Investigator would interfere with evaluations of the investigational medicinal product effect on AA due to scalp inflammation.
- Received the specified treatment regimens within the timeframe outlined in the protocol.
- Prior use of any oral Janus kinase inhibitor (JAKi) or the topical JAKi ruxolitinib for more than 24 months, regardless if washout period is respected.
- Subjects with shaved heads must not enter the study until hair has grown back and SALT score can be reliably administered.
Study Arms:
Experimental: Amlitelimab dose group 1
SC injection as per protocol
Drug: Amlitelimab
Experimental: Amlitelimab dose group 2
SC injection as per protocol
Drug: Amlitelimab
Placebo Comparator: Placebo
SC injection as per protocol
Drug: Placebo
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).
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 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.
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 Clinician-reported outcome (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 EB hair loss. Scores range from "0 = normal appearance/no EB hair loss" to "3 = severe appearance/severe EB hair loss".
10. Proportion of participants achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 with >=2-point improvement from baseline at Weeks 24 and 36 (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 NRS measuring EL hair loss. Scores range from "0 = normal appearance/no EL hair loss" to "3 = severe appearance/severe EL hair loss".
11. Proportion of participants achieving a Patient Global Impression of Change (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 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 Patient Global Impression of Severity (PGI-S) response defined as a score of "mild" or "none" at Weeks 24 and 36
[Time frame: Week 24 and 36]
The 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-16 for AA (SKINDEX-16AA) at Weeks 24 and 36
[Time frame: Baseline to Week 24 and 36]
The 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 patient-reported outcomes (PRO) Scalp Hair Assessment score of 0 to 1 with >=2-point improvement from baseline at Weeks 24 and 36 (among participants with PRO Scalp Hair Assessment score >=3 at Baseline)
[Time frame: Week 24 and 36]
Scalp Hair Assessment 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 at Weeks 24 and 36 (among participants with PRO Measure for EB Hair Loss >=2 at Baseline)
[Time frame: Week 24 and 36]
PRO Measure for EB Hair Loss is a single item, patient-reported NRS measuring EB hair loss, ranging from 0 to 3, with "0 = full coverage/no EB hair loss" and "3 = barely any/no notable EB 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 for EL Hair Loss is a single item, patient-reported NRS measuring EL hair loss, ranging from 0 to 3, with "0 = full coverage/no EL hair loss" and "3 = barely any/no notable EL 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 anti-drug antibodies (ADAs) of amlitelimab at prespecified timepoints
[Time frame: Up to Week 156]
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
