Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

Moderate-to-Severe Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03989349
• Other study ID #: RD.06.SPR.118169
• Status: Completed
• Phase: Phase 3
• Start date: June 30, 2019
• Est. completion date: September 26, 2022

Study information

• Verified date: January 2023
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of the study is to assess the efficacy and safety of nemolizumab after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD) not adequately controlled with topical treatments.

Description:

This is a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in adult and adolescent subjects of age 12 years and above with moderate-to-severe AD. Eligible subjects must have a documented history of inadequate response to topical AD medication(s). Approximately 750 subjects will be randomized in 2:1 to receive either nemolizumab or placebo, stratified by baseline disease severity (Investigator's Global Assessment (IGA) = 3, moderate; IGA = 4, severe) and peak pruritus numeric rating scale (PP NRS) severity (PP NRS = 7; PP NRS < 7).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 788
• Est. completion date: September 26, 2022
• Est. primary completion date: September 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Key Inclusion Criteria:

• Male or female subjects aged = 12 years at the screening visit Note: Enrollment of subjects aged 12 to 17 years has been opened after the IDMC has assessed interim safety data from the phase 2 study (Protocol 116912) and provided recommendations to the sponsor, who then determined the eligibility of this age group for enrollment in the study
• Chronic AD that has been documented for at least 2 years
• EASI score = 16
• IGA score = 3
• AD involvement = 10% of BSA
• PPNRS score of at least 4.0 at the screening and baseline visit
• Documented recent history of inadequate response to topical medications (TCS with or without TCI)
• Female subjects of childbearing potential (that is, fertile, following menarche and until becoming postmenopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection

Key Exclusion Criteria:

• Body weight < 30 kg
• Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study
• Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit Note: Subjects with chronic, stable use of prophylactic treatment for recurrent herpes viral infection can be included in this clinical study
• History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) or to any of the study drug excipients
• Any clinically significant issue, based on investigator judgement

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Moderate-to-Severe Atopic Dermatitis

Intervention

Drug:
• Placebo
Placebo
• Nemolizumab
Nemolizumab

Locations

Country	Name	City	State
Belgium	Galderma Investigational Site 5448	Brussel
Belgium	Galderma Investigational Site 6163	Edegem
Belgium	Galderma Investigational Site 6164	Gent
Belgium	Galderma Investigational Site 6038	Leuven
Belgium	Galderma Investigational Site 6162	Liège
Bulgaria	Galderma Investigational Site 6029	Pleven
Bulgaria	Galderma Investigational Site 6034	Plovdiv
Bulgaria	Galderma Investigational Site 6046	Sofia
Bulgaria	Galderma Investigational Site 6051	Sofia
Bulgaria	Galderma Investigational Site 6078	Sofia
Bulgaria	Galderma Investigational Site 6079	Sofia
Bulgaria	Galderma Investigational Site 6080	Sofia
Bulgaria	Galderma Investigational Site 6101	Sofia
Bulgaria	Galderma Investigational Site 6102	Sofia
Bulgaria	Galderma Investigational Site 6165	Sofia
Bulgaria	Galderma Investigational Site 6216	Sofia
Bulgaria	Galderma Investigational Site 6250	Sofia
Bulgaria	Galderma Investigational Site 6136	Stara Zagora
Bulgaria	Galderma Investigational Site 6251	Stara Zagora
Estonia	Galderma Investigational Site 6068	Tallin
Estonia	Galderma Investigational Site 6069	Tallinn
Estonia	Galderma Investigational Site 6067	Tartu
France	Galderma Investigational Site 5104	Brest
France	Galderma Investigational Site 6198	Le Mans
France	Galderma Investigational Site 5031	Lille
France	Galderma Investigational Site 6171	Lille
France	Galderma Investigational Site 6170	Martigues
France	Galderma Investigational Site 6167	Nantes
France	Galderma Investigational Site 5140	Nice
France	Galderma Investigational Site 6133	Paris
France	Galderma Investigational Site 6166	Paris
France	Galderma Investigational Site 5407	Pierre-Bénite
France	Galderma Investigational Site 6135	Quimper
France	Galderma Investigational Site 5137	Saint-Priest-en-Jarez
France	Galderma Investigational Site 6197	Toulon
France	Galderma Investigational Site 6169	Toulouse
France	Galderma Investigational Site 6168	Valence
Georgia	Galderma Investigation Site 6228	Tbilisi
Georgia	Galderma Investigational Site 6224	Tbilisi
Georgia	Galderma Investigational Site 6227	Tbilisi
Georgia	Galderma Investigational Site 6230	Tbilisi
Georgia	Galderma Investigational Site 6234	Tbilisi
Georgia	Galderma Investigational Site 6235	Tbilisi
Georgia	Galderma Investigational Site 6238	Tbilisi
Georgia	Galderma Investigational Site 6236	Zugdidi
Germany	Galderma Investigational Site 5482	Aachen
Germany	Galderma Investigational Site 5566	Augsburg
Germany	Galderma Investigational Site 6114	Augsburg
Germany	Galderma Investigational Site 6082	Bonn
Germany	Galderma Investigational Site 6132	Dresden
Germany	Galderma Investigational Site 6031	Duesseldorf
Germany	Galderma Investigational Site 6083	Frankfurt
Germany	Galderma Investigational Site 5442	Gera
Germany	Galderma Investigational Site 6081	Goettigen
Germany	Galderma Investigational Site 6062	Halle
Germany	Galderma Investigational Site 6040	Hamburg
Germany	Galderma Investigational Site 6041	Hamburg
Germany	Galderma Investigational Site 6150	Hamburg
Germany	Galderma Investigational Site 5469	Heidelberg
Germany	Galderma Investigational Site 6086	Kiel
Germany	Galderma Investigational Site 6084	Mainz
Germany	Galderma Investigational Site 5382	Munich
Hungary	Galderma Investigational Site 5513	Budapest
Hungary	Galderma Investigational Site 6147	Budapest
Hungary	Galderma Investigational Site 5567	Debrecen
Hungary	Galderma Investigational Site 6026	Debrecen
Hungary	Galderma Investigational Site 6254	Gyula
Hungary	Galderma Investigational Site 6043	Szekszárd
Hungary	Galderma Investigational Site 6053	Veszprém
Italy	Galderma Investigational Site 6179	Ancona
Italy	Galderma Investigational Site 6145	Bologna
Italy	Galderma Investigational Site 6181	Catania
Italy	Galderma Investigational Site 6141	Chieti
Italy	Galderma Investigational Site 6115	Florence
Italy	Galderma Investigational Site 6176	Genova
Italy	Galderma Investigational Site 6045	L'Aquila
Italy	Galderma Investigational Site 6144	Modena
Italy	Galderma Investigational Site 6178	Naples
Italy	Galderma Investigational Site 6151	Parma
Italy	Galderma Investigational Site 6180	Pavia
Italy	Galderma Investigational Site 6182	Perugia
Italy	Galderma Investigational Site 6143	Pisa
Italy	Galderma Investigational Site 6044	Roma
Italy	Galderma Investigational Site 6049	Roma
Italy	Galderma Investigational Site 6177	Rome
Italy	Galderma Investigational Site 6155	Rozzano
Italy	Galderma Investigational Site 6142	Torino
Italy	Galderma Investigational Site 6175	Vicenza
Poland	Galderma Investigational Site 5773	Bialystok
Poland	Galderma Investigational Site 6097	Chorzów
Poland	Galderma Investigational Site 5362	Cracovia
Poland	Galderma Investigational Site 5021	Katowice
Poland	Galderma Investigational Site 6052	Kraków
Poland	Galderma Investigational Site 5363	Lódz
Poland	Galderma Investigational Site 5367	Lublin
Poland	Galderma Investigational Site 5377	Nowa Sól
Poland	Galderma Investigational Site 6063	Olsztyn
Poland	Galderma Investigational Site 6085	Poznan
Poland	Galderma Investigational Site 5495	Rzeszów
Poland	Galderma Investigational Site 6130	Szczecin
Poland	Galderma Investigational Site 6048	Tarnów
Poland	Galderma Investigational Site 5707	Warsaw
Poland	Galderma Investigational Site 6126	Warsaw
Poland	Galderma Investigational Site 6096	Wroclaw
Poland	Galderma Investigational Site 6185	Wroclaw
Singapore	Galderma Investigational Site 5499	Singapore
Singapore	Galderma Investigational Site 6077	Singapore
Singapore	Galderma Investigational Site 6124	Singapore
United States	Galderma Investigational Site 8906	Bell Gardens	California
United States	Galderma Investigational Site 8749	Birmingham	Alabama
United States	Galderma Investigational Site 8893	Birmingham	Alabama
United States	Galderma Investigational Site 8741	Buffalo	New York
United States	Galderma Investigational Site 8905	Canoga Park	California
United States	Galderma Investigational Site 8705	Chattanooga	Tennessee
United States	Galderma Investigational Site 8747	Cincinnati	Ohio
United States	Galderma Investigational Site 8667	Columbus	Georgia
United States	Galderma Investigational Site 8723	Cortland	New York
United States	Galderma Investigational Site 8875	Delray Beach	Florida
United States	Galderma Investigational Site 8554	Detroit	Michigan
United States	Galderma Investigational Site 8577	Encinitas	California
United States	Galderma Investigational Site 8637	Farmington	Connecticut
United States	Galderma Investigational Site 8617	Farmington Hills	Michigan
United States	Galderma Investigational Site 8224	Fremont	California
United States	Galderma Investigational Site 8673	Garden Grove	California
United States	Galderma Investigational Site 8823	Greensboro	North Carolina
United States	Galderma Investigational Site 8866	Guntersville	Alabama
United States	Galderma Investigational Site 8506	Hackensack	New Jersey
United States	Galderma Investigational Site 8391	Hialeah	Florida
United States	Galderma Investigational Site 8727	Hialeah	Florida
United States	Galderma Investigational Site 8807	Houston	Texas
United States	Galderma Investigational Site 8523	Largo	Florida
United States	Galderma Investigational Site 8675	Las Vegas	Nevada
United States	Galderma Investigational Site 8825	Las Vegas	Nevada
United States	Galderma Investigational Site 8683	Los Angeles	California
United States	Galderma Investigational Site 8656	Miami	Florida
United States	Galderma Investigational Site 8704	Miami	Florida
United States	Galderma Investigational Site 8706	Miami	Florida
United States	Galderma Investigational Site 8719	Miami	Florida
United States	Galderma Investigational Site 8724	New Albany	Indiana
United States	Galderma Investigational Site 8733	New York	New York
United States	Galderma Investigational Site 8821	New York	New York
United States	Galderma Investigational Site 8907	Newport Beach	California
United States	Galderma Investigational Site 8713	North Charleston	South Carolina
United States	Galderma Investigational Site 8799	Ontario	California
United States	Galderma Investigational Site 8745	Pasadena	California
United States	Galderma Investigational Site 8721	Pittsburgh	Pennsylvania
United States	Galderma Investigational Site 8212	Portland	Oregon
United States	Galderma Investigational Site 8030	Raleigh	North Carolina
United States	Galderma Investigational Site 8896	Richmond	Virginia
United States	Galderma Investigational Site 8729	Rolling Meadows	Illinois
United States	Galderma Investigational Site 8672	Salt Lake City	Utah
United States	Galderma Investigational Site 8658	San Diego	California
United States	Galderma Investigational Site 8692	San Diego	California
United States	Galderma Investigational Site 8536	Santa Ana	California
United States	Galderma Investigational Site 8808	Scottsdale	Arizona
United States	Galderma Investigational Site 8434	Seattle	Washington
United States	Galderma Investigational Site 8203	Tampa	Florida
United States	Galderma Investigational Site 8839	Tampa	Florida
United States	Galderma Investigational Site 8618	Waco	Texas
United States	Galderma Investigational Site 8226	Warren	Michigan
United States	Galderma Investigational Site 8003	Webster	Texas
United States	Galderma Investigational Site 8126	West Palm Beach	Florida
United States	Galderma Investigational Site 8820	Westminster	California

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Estonia,  France,  Georgia,  Germany,  Hungary,  Italy,  Poland,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with an IGA success (IGA of 0 or 1) and a = 2-point reduction	IGA success rate defined as the proportion of subjects who achieve an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 16.	Baseline to Week 16
Primary	Proportion of subjects with EASI-75		Baseline to Week 16
Secondary	Proportion of subjects with an improvement of PP NRS = 4		Week 16
Secondary	Proportion of subjects with PP NRS < 2		Week 16
Secondary	Proportion of subjects with an improvement of sleep disturbance NRS (SD NRS) = 4		Week 16
Secondary	Proportion of subjects with an improvement of PP NRS = 4		Week 4
Secondary	Proportion of subjects with PP NRS < 2		Week 4
Secondary	Proportion of subjects with an improvement of PP NRS = 4		Week 2
Secondary	Proportion of subjects with an improvement of PP NRS = 4		Week 1
Secondary	Proportion of subjects with EASI-75 and improvement of PP NRS = 4		Week 16
Secondary	Proportion of subjects with IGA success and improvement of PP NRS = 4		Week 16