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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06444451




Registration number
NCT06444451
Ethics application status
Date submitted
31/05/2024
Date registered
5/06/2024
Date last updated
5/11/2024

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata
Scientific 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
Secondary ID [1] 0 0
2024-511225-64
Secondary ID [2] 0 0
DRI18180
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alopecia Areata 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Amlitelimab
Treatment: Drugs - Placebo

Experimental: Amlitelimab dose group 1 - Subcutaneous injection as per protocol

Experimental: Amlitelimab dose group 2 - Subcutaneous injection as per protocol

Placebo comparator: Placebo - Subcutaneous injection as per protocol


Treatment: Drugs: Amlitelimab
Pharmaceutical form: Injection solution Route of administration: SC injection

Treatment: Drugs: Placebo
Pharmaceutical form: Injection solution Route of administration: SC injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in Severity of Alopecia Tool (SALT) score at Week 24
Timepoint [1] 0 0
Baseline to Week 24
Secondary outcome [1] 0 0
Change from the baseline in SALT score at Week 36 (key secondary)
Timepoint [1] 0 0
Baseline to Week 36
Secondary outcome [2] 0 0
Proportion of participants achieving a SALT score =20 at Weeks 24 and 36
Timepoint [2] 0 0
Week 24 and 36
Secondary outcome [3] 0 0
Time to SALT score =20
Timepoint [3] 0 0
Up to Week 36
Secondary outcome [4] 0 0
Proportion of participants achieving a SALT score =10 at Weeks 24 and 36
Timepoint [4] 0 0
Week 24 and 36
Secondary outcome [5] 0 0
Time to SALT score =10
Timepoint [5] 0 0
Up to Week 36
Secondary outcome [6] 0 0
Proportion of participants achieving a SALT50 at Weeks 24 and 36
Timepoint [6] 0 0
Week 24 and 36
Secondary outcome [7] 0 0
Proportion of participants achieving a SALT75 at Weeks 24 and 36
Timepoint [7] 0 0
Week 24 and36
Secondary outcome [8] 0 0
Proportion of participants achieving a SALT90 at Weeks 24 and 36
Timepoint [8] 0 0
Week 24 and 36
Secondary outcome [9] 0 0
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)
Timepoint [9] 0 0
Week 24 and 36
Secondary outcome [10] 0 0
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)
Timepoint [10] 0 0
Week 24 and 36
Secondary outcome [11] 0 0
Proportion of participants achieving a PGI-C response defined as a score of "moderately improved" or "greatly improved" at Weeks 24 and 36
Timepoint [11] 0 0
Week 24 and 36
Secondary outcome [12] 0 0
Proportion of participants achieving a PGI-S response defined as a score of "mild" or "none" at Weeks 24 and 36
Timepoint [12] 0 0
Week 24 and 36
Secondary outcome [13] 0 0
Mean changes from baseline in SKINDEX-16AA at Weeks 24 and 36
Timepoint [13] 0 0
Baseline to Week 24 and 36
Secondary outcome [14] 0 0
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)
Timepoint [14] 0 0
Week 24 and 36
Secondary outcome [15] 0 0
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)
Timepoint [15] 0 0
Week 24 and 36
Secondary outcome [16] 0 0
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)
Timepoint [16] 0 0
Week 24 and 36
Secondary outcome [17] 0 0
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)
Timepoint [17] 0 0
Up to week 52
Secondary outcome [18] 0 0
Serum amlitelimab concentrations measured at prespecified timepoints
Timepoint [18] 0 0
Up to Week 52
Secondary outcome [19] 0 0
Incidence of ADAs) of amlitelimab at prespecified timepoints
Timepoint [19] 0 0
Up to Week 52

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/02/2028
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360001 - Darlinghurst
Recruitment hospital [2] 0 0
Investigational Site Number : 0360003 - East Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
South Dakota
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Santa Fe
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Sofia
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
Manitoba
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Chile
State/province [18] 0 0
Reg Metropolitana De Santiago
Country [19] 0 0
China
State/province [19] 0 0
Chengdu
Country [20] 0 0
China
State/province [20] 0 0
Hangzhou
Country [21] 0 0
China
State/province [21] 0 0
Shanghai
Country [22] 0 0
Czechia
State/province [22] 0 0
Ostrava
Country [23] 0 0
Czechia
State/province [23] 0 0
Prague
Country [24] 0 0
France
State/province [24] 0 0
Brest
Country [25] 0 0
France
State/province [25] 0 0
Nice
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
Germany
State/province [27] 0 0
Berlin
Country [28] 0 0
Germany
State/province [28] 0 0
Osnabrück
Country [29] 0 0
Italy
State/province [29] 0 0
Roma
Country [30] 0 0
Japan
State/province [30] 0 0
Fukuoka
Country [31] 0 0
Japan
State/province [31] 0 0
Kanagawa
Country [32] 0 0
Japan
State/province [32] 0 0
Kumamoto
Country [33] 0 0
Japan
State/province [33] 0 0
Tokyo
Country [34] 0 0
Japan
State/province [34] 0 0
Yokohama-shi
Country [35] 0 0
Netherlands
State/province [35] 0 0
Rotterdam
Country [36] 0 0
Romania
State/province [36] 0 0
Cluj-Napoca
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona [Barcelona]
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid
Country [39] 0 0
Spain
State/province [39] 0 0
Alicante
Country [40] 0 0
Spain
State/province [40] 0 0
Córdoba
Country [41] 0 0
United Kingdom
State/province [41] 0 0
London, City Of
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Manchester
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Oxfordshire
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Dundee
Country [45] 0 0
United Kingdom
State/province [45] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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 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).
Trial website
https://clinicaltrials.gov/study/NCT06444451
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06444451