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


Galderma R&D
NCT ID: NCT03989349
Last Updated: May 19, 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.

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: NCT03989349

Location

Contacts

Galderma Investigational Site

Birmingham, Alabama 35244

United States

Galderma Investigational Site

Scottsdale, Arizona 85255

United States

Galderma Investigational Site

Encinitas, California 92024

United States

Galderma Investigational Site

Fremont, California 94538

United States

Galderma Investigational Site

Los Angeles, California 90033

United States

Galderma Investigational Site

Ontario, California 91762

United States

Galderma Investigational Site

Pasadena, California 91105

United States

Galderma Investigational Site

San Diego, California 92121

United States

Galderma Investigational Site

San Diego, California 92123

United States

Galderma Investigational Site

Santa Ana, California 92705

United States

Galderma Investigational Site

Hialeah, Florida 33016

United States

Galderma Investigational Site

Largo, Florida 33770

United States

Galderma Investigational Site

Miami, Florida 33125

United States

Galderma Investigational Site

Miami, Florida 33155

United States

Galderma Investigational Site

Miami, Florida 33175

United States

Galderma Investigational Site

Oakland Park, Florida 33334

United States

Galderma Investigational Site

Tampa, Florida 33607

United States

Galderma Investigational Site

West Palm Beach, Florida 33401

United States

Galderma Investigational Site

Columbus, Georgia 31904

United States

Galderma Investigational Site

Stockbridge, Georgia 30281

United States

Galderma Investigational Site

Rolling Meadows, Illinois 60008

United States

Galderma Investigational Site

New Albany, Indiana 47150

United States

Galderma Investigational Site

Farmington Hills, Michigan 48334

United States

Galderma Investigational Site

Warren, Michigan 48088

United States

Galderma Investigational Site

Omaha, Nebraska 68114

United States

Galderma Investigational Site

Omaha, Nebraska 68144

United States

Galderma Investigational Site

Las Vegas, Nevada 89119

United States

Galderma Investigational Site

Buffalo, New York 14221

United States

Galderma Investigational Site

Cortland, New York 13045

United States

Galderma Investigational Site

New York, New York 10573

United States

Galderma Investigational Site

Raleigh, North Carolina 27612

United States

Galderma Investigational Site

Cincinnati, Ohio 45219

United States

Galderma Investigational Site

Norman, Oklahoma 73071

United States

Galderma Investigational Site

Portland, Oregon 97210

United States

Galderma Investigational Site

Pittsburgh, Pennsylvania 15213

United States

Galderma Investigational Site

Plymouth Meeting, Pennsylvania 19462

United States

Galderma Investigational Site

Sugarloaf, Pennsylvania 18249

United States

Galderma Investigational Site

North Charleston, South Carolina 29420

United States

Galderma Investigational Site

Chattanooga, Tennessee 37421

United States

Galderma Investigational Site

Houston, Texas 77036

United States

Galderma Investigational Site

Houston, Texas 77036

United States

Galderma Investigational Site

Waco, Texas 76710

United States

Galderma Investigational Site

Webster, Texas 77598

United States

Galderma Investigational Site

Salt Lake City, Utah 84177

United States

Galderma Investigational Site

Brussel, 1200

Belgium

Galderma Investigational Site

Edegem, 2650

Belgium

Galderma Investigational Site

Gent, 9000

Belgium

Galderma Investigational Site

Leuven, 3000

Belgium

Galderma Investigational Site

Liège, 4000

Belgium

Galderma Investigational Site

Pleven, 5800

Bulgaria

Galderma Investigational Site

Plovdiv, 4002

Bulgaria

Galderma Investigational Site

Sofia, 1407

Bulgaria

Galderma Investigational Site

Sofia, 1408

Bulgaria

Galderma Investigational Site 2

Sofia, 1431

Bulgaria

Galderma Investigational Site

Sofia, 1431

Bulgaria

Galderma Investigational Site

Sofia, 1606

Bulgaria

Galderma Investigational Site

Sofia, 1612

Bulgaria

Galderma Investigational Site

Sofia, 1618

Bulgaria

Galderma Investigational Site

Sofia, 166

Bulgaria

Galderma Investigational Site

Stara Zagora, 6000

Bulgaria

Galderma Investigational Site 2

Tallinn, 11313

Estonia

Galderma Investigational Site

Tallin, 10134

Estonia

Galderma Investigational Site

Tartu, 50417

Estonia

Galderma Investigational Site

Brest, 29200

France

Galderma Investigational Site

Lille, 59000

France

Galderma Investigational Site

Martigues, 13500

France

Galderma Investigational Site

Nantes, 44093

France

Galderma Investigational Site

Paris, 75010

France

Galderma Investigational Site

Paris, 75015

France

Galderma Investigational Site

Pierre-Bénite, 69495

France

Galderma Investigational Site

Toulouse, 31000

France

Galderma Investigational Site

Valence, 26000

France

Galderma Investigational Site

Aachen, 52074

Germany

Galderma Investigational Site

Augsburg, 86156

Germany

Galderma Investigational Site

Augsburg, 86179

Germany

Galderma Investigational Site

Bonn, 53105

Germany

Galderma Investigational Site

Dresden, 1097

Germany

Galderma Investigational Site

Duesseldorf, 40225

Germany

Galderma Investigational Site

Frankfurt am main, 60590

Germany

Galderma Investigational Site

Gera, 7548

Germany

Galderma Investigational Site

Goettigen, 37075

Germany

Galderma Investigational Site

Halle, 6120

Germany

Galderma Investigational Site

Hamburg, 20251

Germany

Galderma Investigational Site

Hamburg, 20537

Germany

Galderma Investigational Site

Hamburg, 22391

Germany

Galderma Investigational Site

Heidelberg, 69120

Germany

Galderma Investigational Site

Kiel, 24148

Germany

Galderma Investigational Site

Mainz, 55131

Germany

Galderma Investigational Site

Munich, 80337

Germany

Galderma Investigational Site

München, 80802

Germany

Galderma Investigational Site

Budapest, 1036

Hungary

Galderma Investigational Site

Budapest, 1037

Hungary

Galderma Investigational Site

Debrecen, 4032

Hungary

Galderma Investigational Site

Szeged, 6720

Hungary

Galderma Investigational Site

Szekszárd, 7100

Hungary

Galderma Investigational Site

Veszprém, 8200

Hungary

Galderma Investigational Site

Ancona, 60126

Italy

Galderma Investigational Site

Bologna, 40138

Italy

Galderma Investigational Site

Catania, 95123

Italy

Galderma Investigational Site

Chieti, 66013

Italy

Galderma Investigational Site

Florence, 50125

Italy

Galderma Investigational Site

Genova, 16132

Italy

Galderma Investigational Site

L'Aquila, 67100

Italy

Galderma Investigational Site

Messina, 98124

Italy

Galderma Investigational Site

Milan, 20122

Italy

Galderma Investigational Site

Modena, 41124

Italy

Galderma Investigational Site

Naples, 80131

Italy

Galderma Investigational Site

Parma, 43124

Italy

Galderma Investigational Site

Pavia, 27100

Italy

Galderma Investigational Site

Perugia, 6123

Italy

Galderma Investigational Site

Pisa, 56126

Italy

Galderma Investigational Site

Roma, 00133

Italy

Galderma Investigational Site

Roma, 00168

Italy

Galderma Investigational Site

Rome, 00 144

Italy

Galderma Investigational Site

Rozzano, 20089

Italy

Galderma Investigational Site

Torino, 10126

Italy

Galderma Investigational Site

Vicenza, 36100

Italy

Galderma Investigational Site

Seoul, 06591

Korea, Republic of

Galderma Investigational Site

Białystok, 15-453

Poland

Galderma Investigational Site

Chorzów, 41-500

Poland

Galderma Investigational Site

Cracovia, 30-033

Poland

Galderma Investigational Site

Gdansk, 80-803

Poland

Galderma Investigational Site

Gdańsk, 80-214

Poland

Galderma Investigational Site

Katowice, 35-055

Poland

Galderma Investigational Site

Katowice, 40-040

Poland

Galderma Investigational Site

Katowice, 40-611

Poland

Galderma Investigational Site

Kraków, 31-559

Poland

Galderma Investigational Site

Lublin, 20-080

Poland

Galderma Investigational Site

Lublin, 20-081

Poland

Galderma Investigational Site

Nowa Sól, 67-100

Poland

Galderma Investigational Site

Olsztyn, 10-229

Poland

Galderma Investigational Site

Poznań, 60-529

Poland

Galderma Investigational Site

Poznań, 60-702

Poland

Galderma Investigational Site

Rzeszów, 35-055

Poland

Galderma Investigational Site

Szczecin, 71-434

Poland

Galderma Investigational Site

Tarnów, 33-100

Poland

Galderma Investigational Site

Warsaw, 01-142

Poland

Galderma Investigational Site

Warsaw, 01-817

Poland

Galderma Investigational Site

Warszawa, 01-192

Poland

Not yet recruiting

Warszawa, 02-507

Poland

Galderma Investigational Site

Warszawa, 02-953

Poland

Galderma Investigational Site

Wrocław, 50-381

Poland

Galderma Investigational Site

Wrocław, 50-566

Poland

Galderma Investigational Site

Wrocław, 51-318

Poland

Galderma Investigational Site

Wrocław, 53-658

Poland

Galderma Investigational Site

Łódź, 90-436

Poland

Galderma Investigational Site

Cluj-Napoca, 400105

Romania

Galderma Investigational Site

Iaşi, 700381

Romania

Galderma Investigational Site

Sibiu, 550245

Romania

Galderma Investigational Site

Singapore, 119228

Singapore

Galderma Investigational Site

Singapore, 169608

Singapore

Galderma Investigational Site

Singapore, 229899

Singapore

Galderma Investigational Site

Singapore, 308205

Singapore