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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

166

Participants

Timeline

Start Date

June 6, 2024

Primary Completion Date

September 17, 2025

Study Completion Date

January 5, 2028

Conditions
Alopecia Areata
Interventions
DRUG

Amlitelimab

Pharmaceutical form: Injection solution Route of administration: SC injection

DRUG

Placebo

Pharmaceutical form: Injection solution Route of administration: SC injection

Trial Locations (74)

1055

Investigational Site Number : 0320004, Buenos Aires

1061

Investigational Site Number : 0320001, Buenos Aires

1612

Investigational Site Number : 1000001, Sofia

2000

Investigational Site Number : 0320002, Rosario

2010

Investigational Site Number : 0360001, Sydney

3002

Investigational Site Number : 0360003, Melbourne

10029

Icahn School of Medicine at Mount Sinai- Site Number : 8400003, New York

10117

Investigational Site Number : 2760008, Berlin

10629

Investigational Site Number : 2760007, Berlin

14004

Investigational Site Number : 7240002, Córdoba

20095

Investigational Site Number : 2760001, Hamburg

20132

Investigational Site Number : 3800004, Milan

28031

Investigational Site Number : 7240006, Madrid

28040

Investigational Site Number : 7240008, Madrid

28210

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

28223

Investigational Site Number : 7240007, Pozuelo de Alarcón

29200

Investigational Site Number : 2500001, Brest

33165

New Horizon Research Center- Site Number : 8400017, Miami

35205

Total Skin and Beauty Dermatology Center- Site Number : 8400018, Birmingham

40138

Investigational Site Number : 3800001, Bologna

44124

Apex Clinical Research Center- Site Number : 8400027, Mayfield Heights

44195

Cleveland Clinic- Site Number : 8400028, Cleveland

46256

Dawes Fretzin Clinical Research- Site Number : 8400010, Indianapolis

48149

Investigational Site Number : 2760003, Münster

48346

Michigan Center for Research Company- Site Number : 8400016, Clarkston

49074

Investigational Site Number : 2760004, Osnabrück

57702

Health Concepts- Site Number : 8400001, Rapid City

68144

Joel Schlessinger, PC- Site Number : 8400021, Omaha

74136

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

75010

Investigational Site Number : 2500003, Paris

76031

Investigational Site Number : 2500004, Rouen

78229

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

80131

Investigational Site Number : 3800003, Naples

86150

Investigational Site Number : 2760006, Augsburg

90045

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

92697

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

92708

First OC Dermatology- Site Number : 8400014, Fountain Valley

94538

Center for Dermatology Clinical Research- Site Number : 8400008, Fremont

97201

Oregon Medical Research Center- Site Number : 8400002, Portland

200040

Investigational Site Number : 1560001, Shanghai

310009

Investigational Site Number : 1560006, Hangzhou

400006

Investigational Site Number : 6420001, Cluj-Napoca

610041

Investigational Site Number : 1560022, Chengdu

7580206

Investigational Site Number : 1520003, Santiago

7640881

Investigational Site Number : 1520001, Santiago

8380465

Investigational Site Number : 1520004, Santiago

8420383

Investigational Site Number : 1520002, Santiago

T2J 7E1

Investigational Site Number : 1240005, Calgary

T2W 4X9

Investigational Site Number : 1240007, Calgary

R3M 3Z4

Investigational Site Number : 1240001, Winnipeg

L8L 3C3

Investigational Site Number : 1240003, Hamilton

L3P 1X2

Investigational Site Number : 1240006, Markham

702 00

Investigational Site Number : 2032104, Ostrava

150 00

Investigational Site Number : 2030011, Prague

158 00

Investigational Site Number : 2030012, Prague

06202

Investigational Site Number : 2500002, Nice

00168

Investigational Site Number : 3800002, Rome

243-0432

Investigational Site Number : 3920003, Ebina-shi

221-0825

Investigational Site Number : 3920001, Yokohama

Investigational Site Number : 3920001, Yokohama

861-3106

Investigational Site Number : 3920002, Kamiamakusa

136-0075

Investigational Site Number : 3920005, Koto-ku

814-0171

Investigational Site Number : 3920004, Fukuoka

160-0023

Investigational Site Number : 3920006, Tokyo

3015 CE

Investigational Site Number : 5280004, Rotterdam

08035

Investigational Site Number : 7240005, Barcelona

08036

Investigational Site Number : 7240010, Barcelona

03010

Investigational Site Number : 7240004, Alicante

SW10 9NH

Investigational Site Number : 8260003, London

M6 8HD

Investigational Site Number : 8260004, Salford

OX3 7LE

Investigational Site Number : 8260006, Oxford

DD1 9SY

Investigational Site Number : 8260005, Dundee

SE1 9RT

Investigational Site Number : 8260007, London

SE5 9RL

Investigational Site Number : 8260001, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT06444451 - A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata | Biotech Hunter | Biotech Hunter