Clinical trial • Phase II • Dermatology
AMLITELIMAB for Alopecia areata
Phase II trial of AMLITELIMAB for Alopecia areata.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Alopecia areata
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 29-04-2024
- First CTIS Authorization Date
- 23-08-2024
Trial design
Randomised, amlitelimab matching placebo (placebo control). dose and schedule not specified in the ctis public data. Phase II trial in Bulgaria, Netherlands, Italy and others.
- Randomised
- Yes
- Comparator
- Amlitelimab matching placebo (placebo control). Dose and schedule not specified in the CTIS public data.
- Target Sample Size
- 147
- Trial Duration For Participant
- 252
Eligibility
Recruits 147 No vulnerable population selected in the Part I population. The trial is restricted to adult participants; informed consent from adult participants is required. No assent/parental consent procedures are described in the public CTIS record..
- Vulnerable Population
- No vulnerable population selected in the Part I population. The trial is restricted to adult participants; informed consent from adult participants is required. No assent/parental consent procedures are described in the public CTIS record.
Inclusion criteria
- {"criterion_text":"- Definitive diagnosis of AA of more than 6 months."}
- {"criterion_text":"- 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 (ie, equivalent to less than 10% improvement points spontaneous reduction in SALT 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)."}
- {"criterion_text":"- 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 EOS."}
Exclusion criteria
- {"criterion_text":"- Participants that are currently experiencing other forms of alopecia, including but not limited to: androgenetic alopecia, trichotillomania, telogen effluvium, traction alopecia, scarring alopecia."}
- {"criterion_text":"- 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"}
- {"criterion_text":"- Received the specified treatment regimens within the timeframe outlined in the protocol."}
- {"criterion_text":"- Prior use of any oral JAKi or the topical JAKi ruxolitinib for more than 24 months, regardless if washout period is respected."}
- {"criterion_text":"- Subjects with shaved heads must not enter the study until hair has grown back and SALT score can be reliably administered."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline in SALT score at Week 36","definition_or_measurement_approach":"Change from baseline in Severity of Alopecia Tool (SALT) score measured at Week 36 (SALT instrument referenced elsewhere in protocol and inclusion criteria)."}
Secondary endpoints
- {"endpoint_text":"- Change from the baseline in SALT score at Week 24 (key secondary)","definition_or_measurement_approach":"Change from baseline in SALT score measured at Week 24."}
- {"endpoint_text":"- Proportion of participants achieving a SALT score ≤20 at Weeks 24 and 36","definition_or_measurement_approach":"Proportion achieving SALT ≤20 at Weeks 24 and 36."}
- {"endpoint_text":"- Time to SALT score ≤20","definition_or_measurement_approach":"Time-to-event analysis for achieving SALT ≤20."}
- {"endpoint_text":"- Proportion of participants achieving a SALT score ≤10 at Weeks 24 and 36","definition_or_measurement_approach":"Proportion achieving SALT ≤10 at Weeks 24 and 36."}
- {"endpoint_text":"- Time to SALT score ≤10","definition_or_measurement_approach":"Time-to-event analysis for achieving SALT ≤10."}
- {"endpoint_text":"- 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)","definition_or_measurement_approach":"Clinician-reported outcome for eyebrow hair loss (EB); proportion achieving grade 0 or 1 with ≥2-point improvement at Weeks 24 and 36 among those with baseline EB ≥2."}
- {"endpoint_text":"- 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)","definition_or_measurement_approach":"Clinician-reported outcome for eyelash hair loss (EL); proportion achieving grade 0 or 1 with ≥2-point improvement among those with baseline EL ≥2."}
- {"endpoint_text":"- Proportion of participants achieving a PGI-C response defined as a score of “moderately improved” or “greatly improved” at Weeks 24 and 36","definition_or_measurement_approach":"Patient Global Impression of Change (PGI-C); proportion with response of 'moderately improved' or 'greatly improved' at Weeks 24 and 36."}
- {"endpoint_text":"- Proportion of participants achieving a PGI-S response defined as a score of “mild“ or “none” at Weeks 24 and 36","definition_or_measurement_approach":"Patient Global Impression of Severity (PGI-S); proportion scoring 'mild' or 'none' at Weeks 24 and 36."}
- {"endpoint_text":"- Mean changes from baseline in SKINDEX-16AA at Weeks 24 and 36","definition_or_measurement_approach":"Mean change from baseline in SKINDEX-16AA (quality of life instrument) at Weeks 24 and 36."}
- {"endpoint_text":"- 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)","definition_or_measurement_approach":"Patient-reported outcome (Scalp Hair Assessment); proportion achieving score 0–1 with ≥2-point improvement among those with baseline ≥3."}
- {"endpoint_text":"- Proportion of participants achieving grade 0 or 1 with ≥2point improvement from baseline PRO Measure for EB Hair Loss (among participants with PRO Measure for EB Hair Loss ≥2 at Baseline)","definition_or_measurement_approach":"Patient-reported eyebrow hair loss measure; proportion achieving grade 0 or 1 with ≥2-point improvement among those with baseline ≥2."}
- {"endpoint_text":"- Proportion of participants achieving grade 0 or 1 with ≥2point 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)","definition_or_measurement_approach":"Patient-reported eyelash hair loss measure; proportion achieving grade 0 or 1 with ≥2-point improvement among those with baseline ≥2 at Weeks 24 and 36."}
- {"endpoint_text":"- 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)","definition_or_measurement_approach":"Safety endpoints: incidence of TEAEs, TESAEs and AESIs during treatment."}
- {"endpoint_text":"- Serum amlitelimab concentrations measured at prespecified timepoints","definition_or_measurement_approach":"Pharmacokinetic endpoint: serum amlitelimab concentrations at prespecified timepoints."}
- {"endpoint_text":"- Incidence of ADAs) of amlitelimab at prespecified timepoints","definition_or_measurement_approach":"Immunogenicity endpoint: incidence of anti-drug antibodies (ADAs) at prespecified timepoints."}
Recruitment
- Digital Remote Recruitment
- True, video scripts and electronic recruitment assets are included in the recruitment materials (suggesting use of digital/video content), languages and materials prepared for online or digital distribution.
- Planned Sample Size
- 147
- Recruitment Window Months
- 41
- Consent Approach
- Informed consent obtained from adult participants; multiple ICF and subject information documents are provided (adult main ICF and partner/pregnancy ICFs). Consent documents are available in multiple languages (English, Romanian, Bulgarian, Dutch, French, Spanish, Italian, German, Czech as shown in CTIS document listings). No assent or parental consent procedures are described in the public CTIS record.
Methods
- Flyers (K2 recruitment material flyers available in multiple languages as listed in CTIS documents).
- Posters (K2 recruitment material posters available in multiple languages).
- Placebo fact sheets for recruitment (documents labelled placebo fact sheet for multiple countries).
- Video scripts for recruitment (K2 recruitment material placebo video script documents).
- Doctor-to-doctor letters (K2 recruitment material dr-to-dr letters referenced).
- Country-specific K1 recruitment arrangements documents (country-specific recruitment arrangement PDFs available).
Geography
- Total Number Of Sites
- 30
- Total Number Of Participants
- 74
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 17-05-2024
- Latest Decision Or Authorization Date
- 27-10-2025
- Processing Time Days
- 528
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Medical Center Comac Medical Ltd.
- Principal Investigator Name
- Minoo Mehrabian
- Principal Investigator Email
- minoo.mehrabian@comac-medical.com
- Contact Person Name
- Minoo Mehrabian
- Contact Person Email
- minoo.mehrabian@comac-medical.com
- Site Name
- Medical Center Comac Medical Ltd.
- Principal Investigator Name
- Minoo Mehrabian
- Principal Investigator Email
- minoo.mehrabian@comac-medical.com
- Contact Person Name
- Minoo Mehrabian
- Contact Person Email
- minoo.mehrabian@comac-medical.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 29-07-2024
- Latest Decision Or Authorization Date
- 12-03-2026
- Processing Time Days
- 591
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Dermatology Department
- Principal Investigator Name
- Rick Waalboer-Spuij
- Principal Investigator Email
- r.waalboer@erasmusmc.nl
- Contact Person Name
- Rick Waalboer-Spuij
- Contact Person Email
- r.waalboer@erasmusmc.nl
Italy
- Earliest CTIS Part Ii Submission Date
- 25-07-2024
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 606
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Dermatologia
- Principal Investigator Name
- Franco Rongioletti
- Principal Investigator Email
- rongioletti.franco@hsr.it
- Contact Person Name
- Franco Rongioletti
- Contact Person Email
- rongioletti.franco@hsr.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- DIMEC, Department of Medical and Surgical Sciences
- Principal Investigator Name
- Michela Starace
- Principal Investigator Email
- michela.starace2@unibo.it
- Contact Person Name
- Michela Starace
- Contact Person Email
- michela.starace2@unibo.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- Dipartimento di Medicina Clinica e Chirurgia
- Principal Investigator Name
- Paola Nappa
- Principal Investigator Email
- paonappa@unina.it
- Contact Person Name
- Paola Nappa
- Contact Person Email
- paonappa@unina.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- U.O.C. Dermatologia
- Principal Investigator Name
- Ketty Peris
- Principal Investigator Email
- ketty.peris@unicatt.it
- Contact Person Name
- Ketty Peris
- Contact Person Email
- ketty.peris@unicatt.it
France
- Earliest CTIS Part Ii Submission Date
- 12-07-2024
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 609
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Dermatologie
- Principal Investigator Name
- Vivien Hebert
- Principal Investigator Email
- vivien.hebert@chu-rouen.fr
- Contact Person Name
- Vivien Hebert
- Contact Person Email
- vivien.hebert@chu-rouen.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Service de Dermatologie
- Principal Investigator Name
- Thierry PASSERON
- Principal Investigator Email
- thierry.passeron@unice.fr
- Contact Person Name
- Thierry PASSERON
- Contact Person Email
- thierry.passeron@unice.fr
- Site Name
- Centre SABOURAUD
- Department Name
- Dermatologie
- Principal Investigator Name
- Mira Pavlovic
- Principal Investigator Email
- m.pavlovic-ganascia@centresabouraud.fr
- Contact Person Name
- Mira Pavlovic
- Contact Person Email
- m.pavlovic-ganascia@centresabouraud.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Service de Dermatologie
- Principal Investigator Name
- Claire Abasq-Thomas
- Principal Investigator Email
- claire.abasq@chu-brest.fr
- Contact Person Name
- Claire Abasq-Thomas
- Contact Person Email
- claire.abasq@chu-brest.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 29-07-2024
- Latest Decision Or Authorization Date
- 20-03-2026
- Processing Time Days
- 599
- Number Of Sites
- 7
- Number Of Participants
- 14
Sites
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- Dermatologie
- Principal Investigator Name
- Nina Magnolo
- Principal Investigator Email
- nina.magnolo@ukmuenster.de
- Contact Person Name
- Nina Magnolo
- Contact Person Email
- nina.magnolo@ukmuenster.de
- Site Name
- Klinische Forschung Osnabrueck
- Principal Investigator Name
- Sylvia Pauser
- Principal Investigator Email
- sylvia.pauser@klifos.de
- Contact Person Name
- Sylvia Pauser
- Contact Person Email
- sylvia.pauser@klifos.de
- Site Name
- Emovis GmbH
- Department Name
- Dermatology
- Principal Investigator Name
- Guido Burbach
- Principal Investigator Email
- guido.burbach@futuremeds.com
- Contact Person Name
- Guido Burbach
- Contact Person Email
- guido.burbach@futuremeds.com
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Dermatologie/Venerologie/Allergologie
- Principal Investigator Name
- Ulrike Blume-Peytavi
- Principal Investigator Email
- ulrike.blume-peytavi@charite.de
- Contact Person Name
- Ulrike Blume-Peytavi
- Contact Person Email
- ulrike.blume-peytavi@charite.de
- Site Name
- Thermalsole und Schwefelbad Bentheim GmbH
- Department Name
- Dermatologie
- Principal Investigator Name
- Athanasios Tsianakas
- Principal Investigator Email
- a.tsianakas@fk-bentheim.de
- Contact Person Name
- Athanasios Tsianakas
- Contact Person Email
- a.tsianakas@fk-bentheim.de
- Site Name
- Hautarztpraxis Dr. Mihaescu
- Principal Investigator Name
- Virgil-Oreste Mihaescu
- Principal Investigator Email
- info@dr-mihaescu.de
- Contact Person Name
- Virgil-Oreste Mihaescu
- Contact Person Email
- info@dr-mihaescu.de
- Site Name
- Eurofins bioskin GmbH
- Principal Investigator Name
- Swarna Ekanayake-Bohlig
- Principal Investigator Email
- Swarna.Ekanayake@cpt.eurofinseu.com
- Contact Person Name
- Swarna Ekanayake-Bohlig
- Contact Person Email
- Swarna.Ekanayake@cpt.eurofinseu.com
Romania
- Earliest CTIS Part Ii Submission Date
- 29-07-2024
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 602
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Spitalul Clinic Judetean De Urgenta Cluj
- Department Name
- Medical II
- Principal Investigator Name
- Adrian Lucian Baican
- Principal Investigator Email
- adrian.baican.ext@arensia-em.com
- Contact Person Name
- Adrian Lucian Baican
- Contact Person Email
- adrian.baican.ext@arensia-em.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 30-07-2024
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 591
- Number Of Sites
- 3
- Number Of Participants
- 17
Sites
- Site Name
- Praglandia s.r.o.
- Department Name
- Dermatology
- Principal Investigator Name
- Andrea Vocilkova
- Principal Investigator Email
- a.voc@praglandia.cz
- Contact Person Name
- Andrea Vocilkova
- Contact Person Email
- a.voc@praglandia.cz
- Site Name
- CCR Ostrava s.r.o.
- Department Name
- dermatology
- Principal Investigator Name
- Sylva Zajicova
- Principal Investigator Email
- sylva.zajicova@ccrostrava.com
- Contact Person Name
- Sylva Zajicova
- Contact Person Email
- sylva.zajicova@ccrostrava.com
- Site Name
- Sanixtra CZ s.r.o.
- Department Name
- dermatology
- Principal Investigator Name
- Lucia Mansfeldova
- Principal Investigator Email
- lucia.mansfeldova@sanixtra.eu
- Contact Person Name
- Lucia Mansfeldova
- Contact Person Email
- lucia.mansfeldova@sanixtra.eu
Spain
- Earliest CTIS Part Ii Submission Date
- 08-08-2024
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 586
- Number Of Sites
- 7
- Number Of Participants
- 9
Sites
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Servicio de Dermatologia
- Principal Investigator Name
- Maria del Mar Blanes Martinez
- Principal Investigator Email
- marblanes76@gmail.com
- Contact Person Name
- Maria del Mar Blanes Martinez
- Contact Person Email
- marblanes76@gmail.com
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Servicio de Dermatologia
- Principal Investigator Name
- Eduardo Lopez Bran
- Principal Investigator Email
- lopezbran@salud.madrid.org
- Contact Person Name
- Eduardo Lopez Bran
- Contact Person Email
- lopezbran@salud.madrid.org
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Servicio de Dermatologia
- Principal Investigator Name
- Juan Alberto Ruano Ruiz
- Principal Investigator Email
- juanruanoruiz@mac.com
- Contact Person Name
- Juan Alberto Ruano Ruiz
- Contact Person Email
- juanruanoruiz@mac.com
- Site Name
- Hospital Universitario Infanta Leonor
- Department Name
- Servicio de Dermatologia
- Principal Investigator Name
- Pablo de la Cueva Dobao
- Principal Investigator Email
- pdelacueva@yahoo.com
- Contact Person Name
- Pablo de la Cueva Dobao
- Contact Person Email
- pdelacueva@yahoo.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Servicio de Dermatologia
- Principal Investigator Name
- Andrea Combalia Escudero
- Principal Investigator Email
- acombalia@clinic.cat
- Contact Person Name
- Andrea Combalia Escudero
- Contact Person Email
- acombalia@clinic.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de Dermatologia
- Principal Investigator Name
- Victor Cabezas Calderon
- Principal Investigator Email
- vcabezas91@gmail.com
- Contact Person Name
- Victor Cabezas Calderon
- Contact Person Email
- vcabezas91@gmail.com
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Dermatology
- Principal Investigator Name
- Javier Pedraz Munoz
- Principal Investigator Email
- javierpedraz78@gmail.com
- Contact Person Name
- Javier Pedraz Munoz
- Contact Person Email
- javierpedraz78@gmail.com
Sponsor
Primary sponsor
- Full Name
- Sanofi-Aventis Recherche & Developpement
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Contract research organisations
- Name
- Endpoint Clinical Inc.
- Name
- PPD Development LP
- Name
- Pharmaceutical Product Development LLC
- Name
- Inato
Third parties
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Mapi Research Trust","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Icahn School Of Medicine At Mount Sinai","duties_or_roles":"","organisation_type":"Educational Institution"}
- {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Biorepository Storage","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Inato","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Handling the optional photography (no central reading activities performed)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"ARENSIA Exploratory Medicine GmbH","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Bulgaria","full_name":"Comac Medical Ltd.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Emergency Services 24/7","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Amlitelimab
- Active Substance
- AMLITELIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- 1
- Maximum Dose
- 500 mg
- Investigational Product Name
- Amlitelimab matching placebo to test product
- Modality
- Other
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