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Clinical Trial Details for Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis


Galderma R&D
NCT ID: NCT03985943
Last Updated: May 14, 2020

The Study at a Glance

  • Status: Recruiting
  • Phase: 0
  • Gender: male
  • Age: 12 Years - N/A
  • Condition: Moderate-to-Severe Atopic Dermatitis
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: Galderma R&D
  • Location: Not Provided

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

Purpose

Safety and efficacy of nemolizumab in subjects with moderate-to-severe atopic dermatitis

Eligibility

Ages Eligible for Study

12 Years to N/A

Sexes Eligible for Study

male

Accepts Healthy Volunteers

No

Criteria

Key Inclusion Criteria:

1. Male or female subjects aged ≥ 12 years at the screening visit

Note: Enrollment of subjects aged 12 to 17 years will begin after an IDMC has assessed
interim safety data from the phase 2 study (Protocol 116912) and provided
recommendations to the sponsor, who will then determine the eligibility of this age
group for enrollment in the study.

2. Chronic AD that has been documented for at least 2 years

3. EASI score ≥ 16

4. IGA score ≥ 3

5. AD involvement ≥ 10% of BSA

6. Documented recent history of inadequate response to topical medications (TCS with or
without TCI).

7. Female subjects of childbearing potential must agree either to be strictly abstinent
throughout the study and for 12 weeks after the last study drug injection, or to use
an effective and approved method of contraception throughout the study and for 12
weeks after the last study drug injection, or to use an effective and approved method
of contraception throughout the study and for 12 weeks after the last study drug
injection.

Key Exclusion Criteria:

1. Body weight < 30 kg. 2. Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study 3. Cutaneous infection within 1 week or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week 4. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) 5. Any clinically significant issue, based investigator judgement

Additional Information, Locations & Contacts

Sponsors & Collaborators

Galderma R&D

Investigators

Not Provided

Please refer to this study by its ClinicalTrials.gov identifier: NCT03985943

Location

Contacts

Galderma Investigational Site

Little Rock, Arkansas 72205

United States

Galderma Investigational Site

Beverly Hills, California 90212

United States

Galderma Investigational Site

Fountain Valley, California 92708

United States

Galderma Investigational Site

Lomita, California 90717

United States

Galderma Investigational Site

Los Angeles, California 90025

United States

Galderma Investigational Site

San Diego, California 92108

United States

Galderma Investigational Site

San Francisco, California 94115

United States

Galderma Investigational Site

Santa Monica, California 90404

United States

Galderma Investigational Site

Walnut Creek, California 94598

United States

Galderma Investigational Site

Bridgeport, Connecticut 06606

United States

Galderma Investigational Site

Washington, District of Columbia 20037

United States

Galderma Investigational Site

Washington, District of Columbia 20037

United States

Galderma Investigaitonal Site

Boynton Beach, Florida 33437

United States

Galderma Investigational Site

Cape Coral, Florida 33991

United States

Galderma Investigational Site

Hialeah, Florida 33012

United States

Galderma Investigational Site

Hialeah, Florida 33016

United States

Galderma Investigational Site

Jacksonville, Florida 32256

United States

Galderma Investigational Site

Miami Lakes, Florida 33014

United States

New Investigational Site

Miami, Florida 33125

United States

Galderma Investigational Site

Miami, Florida 33126

United States

Galderma Investigational Site

Miami, Florida 33145

United States

Galderma Investigational Site

Miami, Florida 33166

United States

Galderma Investigational Site

Miami, Florida 33174

United States

Galderma Investigational Site

Miami, Florida 33175

United States

Galderma Investigational Site

Miami, Florida 33176

United States

Galderma Investigational Site

Pembroke Pines, Florida 33028

United States

Galderma Investigational Site

Albany, Georgia 31707

United States

Galderma Investigational Site

Macon, Georgia 31217

United States

Galderma Invesitigational Site

Newnan, Georgia 30263

United States

Galderma Investigational Site

Boise, Idaho 83713

United States

Galderma Investigational Site

Nampa, Idaho 83687

United States

Galderma Investigational Site

Skokie, Illinois 60076

United States

Galderma Investigational Site

Skokie, Illinois 60077

United States

Galderma Investigational Site

Indianapolis, Indiana 46250

United States

Galderma Investigational Site

Louisville, Kentucky 40241

United States

Galderma Investigational Site

Ann Arbor, Michigan 48109

United States

Galderma Investigational Site

Bay City, Michigan 48706

United States

Galderma Investigational Site

Troy, Michigan 48084

United States

Galderma Investigational Site

Ypsilanti, Michigan 48197

United States

Galderma Investigational Site

Saint Joseph, Missouri 64506

United States

Galderma Investigational Site

Missoula, Montana 59808

United States

Galderma Investigational Site

Omaha, Nebraska 68144

United States

Galderma Investigational Site

Henderson, Nevada 89052

United States

Galderma Investigational Site

Lebanon, New Hampshire 003766

United States

Galderma Investigational Site

Albuquerque, New Mexico 87106

United States

Galderma Investigational Site

Brooklyn, New York 11203

United States

Galderma Investigational Site

New York, New York 10023

United States

Galderma Investigational Site

New York, New York 10075

United States

Galderma Investigational Site

Durham, North Carolina 27710

United States

Galderma Investigational Site

Wilmington, North Carolina 28405-3176

United States

Galderma Investigational Site

Wilmington, North Carolina 28405

United States

Galderma Investigational Site

Bexley, Ohio 43209

United States

Galderma Investigational Site

Dublin, Ohio 43016

United States

Galderma Investigaitonal Site

Norman, Oklahoma 73071

United States

Galderma Investigational Site

Philadelphia, Pennsylvania 19103

United States

Galderma Investigational Site

Plymouth Meeting, Pennsylvania 19103

United States

Galderma Investigational Site

Charleston, South Carolina 29425

United States

Galderma Investigational Site

Rapid City, South Dakota 57702

United States

Galderma Investigational Site

Chattanooga, Tennessee 37421

United States

Galderma Investigational Site

Arlington, Texas 76011

United States

Galderma Investigational Site

Austin, Texas 78723

United States

Galderma Investigational Site

Cypress, Texas 77433

United States

Galderma Investigational Site

Dallas, Texas 75230

United States

Galderma Investigational Site

Dripping Springs, Texas 78620

United States

Galderma Investigational Site

Frisco, Texas 75034

United States

Galderma Investigational Site

Houston, Texas 77056

United States

Galderma Investigational Site

Houston, Texas 77401

United States

Galderma Investigational Site

Burke, Virginia 22015

United States

Galderma Investigational Site

Darlinghurst, New South Wales 2010

Australia

Galderma Investigational Site

Kogarah, New South Wales 2217

Australia

Galderma Investigational Site

Benowa, Queensland 4217

Australia

Galderma Investigational Site

Woolloongabba, Queensland 4102

Australia

Not yet recruiting

Woodville, South Australian 5011

Australia

Galderma Investigational Site

Carlton, Victoria 3053

Australia

Galderma Investigational Site

East Melbourne, Victoria 3002

Australia

Galderma Investigational Site

Parkville, Victoria 3050

Australia

Galderma Investigational Site

Parkville, Victoria 3052

Australia

Galderma Investigational Site

Fremantle, Western Australia 6160

Australia

Galderma Investigational Site

Victoria Park, Western Australia 6100

Australia

Galderma Investigational Sites

Graz, Styria 8036

Austria

Galderma Investigational Site

Linz, 4020

Austria

Galderma Investigational Site

Vienna, 1220

Austria

Galderma Investigational Site

Wien, 1090

Austria

Galderma Investigational Site

Calgary, T2G 1B1

Canada

Galderma Investigational Site

Calgary, T3E 0B2

Canada

Galderma Investigational Site

Edmonton, T5J 359

Canada

Galderma Investigational Site

Edmonton, T6G 1C3

Canada

Galderma Investigational Site

Edmonton, T6G 1C9

Canada

Galderma Investigational Site

Hamilton, L7L 2H5

Canada

Galderma Investigational Site

Niagara Falls, L2H 1H5

Canada

Galderma Investigational Site

Ottawa, K1G 6C6

Canada

Galderma Investigational Site

Saint John, A1A 4Y3

Canada

Galderma Investigational Site

Saint John, A1C2H5

Canada

Galderma Investigational Site

Sudbury, P3E 1H5

Canada

Galderma Investigational Site

Toronto, M5A 3R6

Canada

Galderma Investigational Site

Toronto, M9W 4L6

Canada

Galderma Investigational Site

Waterloo, N2J 1C4

Canada

Galderma Investigational Site

Brno, 659 91

Czechia

Galderma Investigational Site

Náchod, 54701

Czechia

Galderma Investigational Site

Olomouc, 779

Czechia

Galderma Investigational Site

Pardubice, 53203

Czechia

Galderma Investigational Site

Prague, 100 00

Czechia

Galderma Investigational Site

Praha, 110 00

Czechia

Galderma Investigational Site

Praha, 11000

Czechia

Galderma Investigational Site

Praha, 150 06

Czechia

Galderma Investigational Site

Langenau, Hesse 89129

Germany

Galderma Investigational Site

Witten, Hesse 58453

Germany

Galderma Investigational Site

Tuebingen, Niedersachesen 72076

Germany

Galderma Investigational Site

Berlin, NRW 12203

Germany

Galderma Investigational Site

Kiel, Schleswig-Holst 24105

Germany

Galderma Investigational Site

Bad Bentheim, 48455

Germany

Galderma Investigational Site

Berlin, 10117

Germany

Galderma Investigational Site

Berlin, 10117

Germany

Galderma Investigational Site

Berlin, 13055

Germany

Galderma Investigational Site

Bielefeld, 33647

Germany

Galderma Investigational Site

Buxtehude, 21614

Germany

Galderma Investigational Site

Darmstadt, 64283

Germany

Galderma Investigational Site

Dülmen, 48249

Germany

Galderma Investigational Site

Friedrichshafen, 88045

Germany

Galderma Investigational Site

Hamburg, 22391

Germany

Galderma Investigational Site

Hannover, 30625

Germany

Galderma Investigational Site

Leipzig, 80337

Germany

Galderma Investigational Site

Lubeck, 23538

Germany

Galderma Investigational Site

Münster, 48149

Germany

Galderma Investigational Site

Osnabrück, 49074

Germany

Galderma Investigational Site

Stuttgart, 70499

Germany

Galderma Investigaitonal Site

Bucheon, 14584

Korea, Republic of

Galderma Investigational Site

Busan, 49241

Korea, Republic of

Galderma Investigaitonal Site

Gyeonggi-do, 15355

Korea, Republic of

Galderma Investigational Site

Gyeonggi-do, 18540

Korea, Republic of

Galderma Investigational Site

Incheon, 21431

Korea, Republic of

Galderma Investigational Site

Incheon, 21565

Korea, Republic of

Galderma Investigaitonal Site

Incheon, 22332

Korea, Republic of

Galderma Investigational Site

Seoul, 02841

Korea, Republic of

Galderma Investigaitonal Site

Seoul, 03080

Korea, Republic of

Galderma Investigational Site

Seoul, 03722

Korea, Republic of

Galderma Investigational Site

Seoul, 04763

Korea, Republic of

Galderma Investigational Site

Seoul, 05030

Korea, Republic of

Galderma Investigaitonal Site

Seoul, 06591

Korea, Republic of

Galderma Investigaitonal Site

Seoul, 06973

Korea, Republic of

Galderma Investigaitonal Site

Seoul, 07441

Korea, Republic of

Galderma Investigational Site

Liepāja, LV-3501

Latvia

Galderma Investigational Site

Riga, LV-1006

Latvia

Galderma Investigational Site

Riga, LV-1009

Latvia

Galderma Investigational Site

Talsi, LV-3201

Latvia

Galderma Investigational Site

Ventspils, LV-3601

Latvia

Galderma Investigational Site

Kaunas, LT-50161

Lithuania

Galderma Investigational Site

Klaipėda, LT-92288

Lithuania

Galderma Investigational Site

Vilnius, LT-01118

Lithuania

Galderma Investigational Site

Vilnius, LT-07195

Lithuania

Galderma Investigational Site

Vilnius, LT-08411

Lithuania

Galderma Investigational Site

Bergen Op Zoom, 4624 VT

Netherlands

Galderma Investigational Site

Groningen, 9713

Netherlands

Galderma Investigational Site

Rotterdam, 3015 GD

Netherlands

Galderma Investigational Site

Utrecht, 3584 CX

Netherlands

Galderma Investigational Site

Christchurch, 8013

New Zealand

Galderma Investigational Site

Hamilton, 3204

New Zealand

Galderma Investigational Site

Wellington, 6021

New Zealand

Galderma Investigational Site

Alicante, 03010

Spain

Galderma Investigational Site

Barcelona, 08036

Spain

Galderma Investigational Site

Barcelona, 08041

Spain

Galderma Investigational Site

Barcelona, 08916

Spain

Galderma Investigational Site

Barcelona, 8907

Spain

Galderma Investigational Site

Las Palmas De Gran Canaria, 35010

Spain

Galderma Investigational Site

Madrid, 28006

Spain

Galderma Investigational Site

Madrid, 28046

Spain

Galderma Investigational Site

Madrid, 28223

Spain

Galderma Investigational Site

Madrid, 28922

Spain

Galderma Investigational Site

Majadahonda, 28222

Spain

Galderma Investigational Site

Málaga, 29010

Spain

Galderma Investigaitonal Site

Pamplona, 31008

Spain

Galderma Investigational Site

Valencia, 46026

Spain

Galderma Investigaitonal Site

Zaragoza, 50009

Spain

Galderma Investigaitonal Site

Barnsley, S75 3DL

United Kingdom

Galderma Investigaitonal Site

Blackpool, FY2 0JH

United Kingdom

Galderma Investigaitonal Site

Cannock, WS11 0BN

United Kingdom

Galderma Investigaitonal Site

Dudley, DY1 2HQ

United Kingdom

Galderma Investigaitonal Site

Lanark, G3 8SJ

United Kingdom

Galderma Investigaitonal Site

Liverpool, L34 1BH

United Kingdom

Galderma Investigaitonal Site

London, SE1 9RT

United Kingdom

Galderma Investigaitonal Site

London, WC1X 8QD

United Kingdom

Galderma Investigaitonal Site

Manchester, M13 9NQ

United Kingdom

Galderma Investigaitonal Site

Newcastle, NE1 4LP

United Kingdom

Galderma Investigational Site

Poole, BH15 2JB

United Kingdom

Galderma Investigational Site

Redhill, RH1 5RH

United Kingdom

Galderma Investigaitonal Site

Stockton-on-Tees, ts17 6ew

United Kingdom