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Alopecia AreataPhase 2NCT06444451

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

A Phase 2 study testing Amlitelimab in people with Alopecia Areata, run by Sanofi at 74 sites in 16 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alopecia Areata
What is being tested?
Amlitelimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
166 participants
Where
74 sitesin 16 countries
Study dates
6 Jun 2024to 21 May 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

74 sites in 16 countries.

74 sites in 16 countries

United States17 sites

  • Total Skin and Beauty Dermatology Center- Site Number : 8400018

    Birmingham, Alabama, 35205

  • DJL Clinical Research - Charlotte - Park Road- Site Number : 8400013

    Charlotte, North Carolina, 28210

  • Michigan Center for Research Company- Site Number : 8400016

    Clarkston, Michigan, 48346

  • Cleveland Clinic- Site Number : 8400028

    Cleveland, Ohio, 44195

  • First OC Dermatology- Site Number : 8400014

    Fountain Valley, California, 92708

  • Center for Dermatology Clinical Research- Site Number : 8400008

    Fremont, California, 94538

  • Dawes Fretzin Clinical Research- Site Number : 8400010

    Indianapolis, Indiana, 46256

  • UC Irvine Healthcare - Gottschalk Medical Plaza- Site Number : 8400007

    Irvine, California, 92697

  • Dermatology Research Associates - Los Angeles- Site Number : 8400015

    Los Angeles, California, 90045

  • Apex Clinical Research Center- Site Number : 8400027

    Mayfield Heights, Ohio, 44124

  • New Horizon Research Center- Site Number : 8400017

    Miami, Florida, 33165

  • Icahn School of Medicine at Mount Sinai- Site Number : 8400003

    New York, New York, 10029

  • Joel Schlessinger, PC- Site Number : 8400021

    Omaha, Nebraska, 68144

  • Oregon Medical Research Center- Site Number : 8400002

    Portland, Oregon, 97201

  • Health Concepts- Site Number : 8400001

    Rapid City, South Dakota, 57702

  • Progressive Clinical Research - San Antonio- Site Number : 8400019

    San Antonio, Texas, 78229

  • Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400004

    Tulsa, Oklahoma, 74136

Other trials in United States

Japan7 sites

  • Investigational Site Number : 3920003

    Ebina-shi, Kanagawa, 243-0432

  • Investigational Site Number : 3920004

    Fukuoka, 814-0171

  • Investigational Site Number : 3920002

    Kamiamakusa, Kumamoto, 861-3106

  • Investigational Site Number : 3920005

    Koto-ku, Tokyo, 136-0075

  • Investigational Site Number : 3920006

    Tokyo, 160-0023

  • Investigational Site Number : 3920001

    Yokohama, Kanagawa, 221-0825

  • Investigational Site Number : 3920001

    Yokohama, 221-0825

Other trials in Japan

Spain7 sites

  • Investigational Site Number : 7240004

    Alicante, 03010

  • Investigational Site Number : 7240005

    Barcelona, Barcelona [Barcelona], 08035

  • Investigational Site Number : 7240010

    Barcelona, Barcelona [Barcelona], 08036

  • Investigational Site Number : 7240002

    Córdoba, 14004

  • Investigational Site Number : 7240006

    Madrid, 28031

  • Investigational Site Number : 7240008

    Madrid, 28040

  • Investigational Site Number : 7240007

    Pozuelo de Alarcón, Madrid, 28223

Other trials in Spain

Germany6 sites

  • Investigational Site Number : 2760006

    Augsburg, 86150

  • Investigational Site Number : 2760008

    Berlin, 10117

  • Investigational Site Number : 2760007

    Berlin, 10629

  • Investigational Site Number : 2760001

    Hamburg, 20095

  • Investigational Site Number : 2760003

    Münster, 48149

  • Investigational Site Number : 2760004

    Osnabrück, 49074

Other trials in Germany

United Kingdom6 sites

  • Investigational Site Number : 8260005

    Dundee, DD1 9SY

  • Investigational Site Number : 8260003

    London, London, City of, SW10 9NH

  • Investigational Site Number : 8260007

    London, SE1 9RT

  • Investigational Site Number : 8260001

    London, SE5 9RL

  • Investigational Site Number : 8260006

    Oxford, Oxfordshire, OX3 7LE

  • Investigational Site Number : 8260004

    Salford, Manchester, M6 8HD

Other trials in United Kingdom

Canada5 sites

  • Investigational Site Number : 1240005

    Calgary, Alberta, T2J 7E1

  • Investigational Site Number : 1240007

    Calgary, Alberta, T2W 4X9

  • Investigational Site Number : 1240003

    Hamilton, Ontario, L8L 3C3

  • Investigational Site Number : 1240006

    Markham, Ontario, L3P 1X2

  • Investigational Site Number : 1240001

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Chile4 sites

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7580206

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7640881

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, 8380465

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 8420383

Other trials in Chile

France4 sites

  • Investigational Site Number : 2500001

    Brest, 29200

  • Investigational Site Number : 2500002

    Nice, 06202

  • Investigational Site Number : 2500003

    Paris, 75010

  • Investigational Site Number : 2500004

    Rouen, 76031

Other trials in France

Italy4 sites

  • Investigational Site Number : 3800001

    Bologna, 40138

  • Investigational Site Number : 3800004

    Milan, Milano, 20132

  • Investigational Site Number : 3800003

    Naples, Napoli, 80131

  • Investigational Site Number : 3800002

    Rome, Roma, 00168

Other trials in Italy

Argentina3 sites

  • Investigational Site Number : 0320004

    Buenos Aires, 1055

  • Investigational Site Number : 0320001

    Buenos Aires, 1061

  • Investigational Site Number : 0320002

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

China3 sites

  • Investigational Site Number : 1560022

    Chengdu, 610041

  • Investigational Site Number : 1560006

    Hangzhou, 310009

  • Investigational Site Number : 1560001

    Shanghai, 200040

Other trials in China

Czechia3 sites

  • Investigational Site Number : 2032104

    Ostrava, 702 00

  • Investigational Site Number : 2030011

    Prague, 150 00

  • Investigational Site Number : 2030012

    Prague, 158 00

Other trials in Czechia

Australia2 sites

  • Investigational Site Number : 0360003

    Melbourne, Victoria, 3002

  • Investigational Site Number : 0360001

    Sydney, New South Wales, 2010

Other trials in Australia

Bulgaria1 site

  • Investigational Site Number : 1000001

    Sofia, 1612

Other trials in Bulgaria

Netherlands1 site

  • Investigational Site Number : 5280004

    Rotterdam, 3015 CE

Other trials in Netherlands

Romania1 site

  • Investigational Site Number : 6420001

    Cluj-Napoca, 400006

Other trials in Romania

About this study

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

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).

Conditions
Alopecia Areata
Being tested
Amlitelimab, Placebo
Medical subject headings
Alopecia Areata

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmlitelimabDrug

    Also called SAR445229

    Pharmaceutical form: Injection solution Route of administration: SC injection

  • PlaceboDrug

    Pharmaceutical form: Injection solution Route of administration: SC injection

Study groups in NCT06444451
Study groupRoleWhat they receive
Amlitelimab dose group 1ExperimentalSubcutaneous injection as per protocol
Receives: Drug: Amlitelimab
Amlitelimab dose group 2ExperimentalSubcutaneous injection as per protocol
Receives: Drug: Amlitelimab
PlaceboPlacebo comparatorSubcutaneous injection as per protocol
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline to Week 36

Secondary outcomes (19)

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

    Measured: Baseline to Week 24

  2. 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).

    Measured: Week 24 and 36

  3. 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).

    Measured: Up to Week 36

  4. 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).

    Measured: Week 24 and 36

  5. 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).

    Measured: Up to Week 36

  6. 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.

    Measured: Week 24 and 36

  7. 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.

    Measured: Week 24 and36

  8. 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.

    Measured: Week 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)

    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

    Measured: Week 24 and 36

  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)

    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.

    Measured: Week 24 and 36

  11. 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.

    Measured: Week 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

    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.

    Measured: Week 24 and 36

  13. 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.

    Measured: Baseline to Week 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)

    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).

    Measured: Week 24 and 36

  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)

    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.

    Measured: Week 24 and 36

  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)

    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.

    Measured: Week 24 and 36

  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)

    Measured: Up to week 156

  18. Serum amlitelimab concentrations measured at prespecified timepoints

    Measured: Up to Week 156

  19. Incidence of ADAs of amlitelimab at prespecified timepoints

    Measured: Up to Week 156

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2024
  2. Study start6 Jun 2024
  3. Primary completion24 Sep 2025
  4. Study completion21 May 2026

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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06444451
Sponsor's protocol ID
DRI18180
Other IDs
2024-511225-64, U1111-1295-6359
Status last verified
Aug 2026
First submitted
31 May 2024
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amlitelimab in people with Alopecia Areata, run by Sanofi at 74 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Japan, Spain, Germany, United Kingdom and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision; the decision is not related to any safety concern). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Severity of Alopecia Tool (SALT) score at Week 36 (time frame: Baseline to Week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06444451.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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