Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis

Moderate-to-Severe Atopic Dermatitis Clinical Trial

Official title:

A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Moderate-to-Severe Atopic Dermatitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03989206
• Other study ID #: RD.06.SPR.118163
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 30, 2019
• Est. completion date: August 31, 2026

Study information

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

Clinical Trial Summary

Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description

Description:

Long-term study to assess the safety and efficacy of nemolizumab in subjects with moderate-to-severe AD

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1700
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Key Inclusion Criteria:

1. Subjects who may benefit from study participation in the opinion of the investigator and had participated in a prior nemolizumab study for AD

2. Female subjects of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal 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 effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.

Key Exclusion Criteria:

1. Subjects who, during their participation in a prior nemolizumab study, experienced an AE which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the subject.

2. Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study.

3. Body weight < 30 kg

4. 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. Subjects may be rescreened once the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods.

5. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody)

6. Any clinically significant issue, based investigator judgement

Related Conditions & MeSH terms

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

Intervention

Drug:
• Nemolizumab
Nemolizumab

Locations

Country	Name	City	State
Australia	Galderma Investigational Site 5638	Benowa	Queensland
Australia	Galderma Investigational Site 6161	Brisbane	Queensland
Australia	Galderma Investigational Site 6131	Carlton	Victoria
Australia	Galderma Investigational Site 5441	Darlinghurst	New South Wales
Australia	Galderma Investigational Site 5366	East Melbourne	Victoria
Australia	Galderma Investigational Site 5759	Kogarah	New South Wales
Australia	Galderma Investigational Site 5458	Parkville	Victoria
Australia	Galderma Investigational Site 6160	Parkville	Victoria
Australia	Galderma Investigational Site 6153	Victoria Park	Western Australia
Australia	Galderma Investigational Site 6152	Westmead	New South Wales
Australia	Galderma Investigational Site 6159	Woodville	South Australia
Austria	Galderma Investigational Site 6157	Graz	Styria
Austria	Galderma Investigational Site 6156	Linz	Oberoesterreich
Austria	Galderma Investigational Site 6158	Vienna
Austria	Galderma Investigational Site 6194	Vienna
Belgium	Galderma Investigational Site 5448	Brussels
Belgium	Galderma Investigational Site 6163	Edegem
Belgium	Galderma Investigational Site 6164	Gent
Belgium	Galderma Investigational Site 6038	Leuven	Vlaams-Brabant
Belgium	Galderma Investigational Site 6162	Liège
Bulgaria	Galderma Investigational Site 6029	Pleven
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
Canada	Galderma Investigational Site 8586	Barrie	Ontario
Canada	Galderma Investigational Site 8085	Calgary	Alberta
Canada	Galderma Investigational Site 8215	Calgary	Alberta
Canada	Galderma Investigational Site 8903	Calgary	Alberta
Canada	Galderma Investigational Site 8722	Edmonton	Alberta
Canada	Galderma Investigational Site 8824	Edmonton	Alberta
Canada	Galderma Investigational Site 8904	Guelph	Ontario
Canada	Galderma Investigational Site 8780	Niagara Falls	Ontario
Canada	Galderma Investigational Site 8610	Ottawa	Ontario
Canada	Galderma Investigational Site 8901	Ottawa	Ontario
Canada	Galderma Investigational Site 8000	Saint John
Canada	Galderma Investigational Site 8161	Surrey	British Columbia
Canada	Galderma Investigational Site 8336	Toronto	Ontario
Canada	Galderma Investigational Site 8899	Toronto	Ontario
Canada	Galderma Investigational Site 8731	Waterloo	Ontario
Czechia	Galderma Investigational Site 6055	Brno
Czechia	Galderma Investigational Site 5225	Náchod
Czechia	Galderma Investigational Site 6030	Olomouc
Czechia	Galderma Investigational Site 6024	Prague
Czechia	Galderma Investigational Site 6240	Prague
Czechia	Galderma Investigational Site 6021	Praha
Czechia	Galderma Investigational Site 6025	Praha
Czechia	Galderma Investigational Site 6054	Praha
Estonia	Galderma Investigational Site 6068	Tallinn
Estonia	Galderma Investigational Site 6069	Tallinn
Estonia	Galderma Investigational Site 6067	Tartu
France	Galderma Investigational Site 6198	Le Mans
France	Galderma Investigational Site 5031	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 6197	Toulon
France	Galderma Investigational Site 6169	Toulouse
France	Galderma Investigational Site 6168	Valence
Georgia	Galderma Investigational Site 6224	Tbilisi
Georgia	Galderma Investigational Site 6227	Tbilisi
Georgia	Galderma Investigational Site 6228	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 6022	Bad Bentheim
Germany	Galderma Investigational Site 6110	Berlin
Germany	Galderma Investigational Site 6061	Bielefeld
Germany	Galderma Investigational Site 6082	Bonn
Germany	Galderma Investigational Site 6062	Buxtehude
Germany	Galderma Investigational Site 5368	Darmstadt
Germany	Galderma Investigational Site 6132	Dresden
Germany	Galderma Investigational Site 6028	Dülmen
Germany	Galderma Investigational Site 6031	Düsseldorf
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 6146	Langenau
Germany	Galderma Investigational Site 6084	Mainz
Germany	Galderma Investigational Site 5382	Munich
Germany	Galderma Investigational Site 6039	Münster
Germany	Galderma Investigational Site 5918	Osnabrück
Germany	Galderma Investigational Site 6109	Stuttgart
Germany	Galderma Investigational Site 6214	Tuebingen
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 6053	Veszprem
Italy	Galderma Investigational Site 6145	Bologna
Italy	Galderma Investigational Site 6045	L'Aquila
Italy	Galderma Investigational Site 6049	Roma
Italy	Galderma Investigational Site 6177	Rome
Italy	Galderma Investigational Site 6155	Rozzano
Italy	Galderma Investigational Site 6175	Vicenza
Korea, Republic of	Galderma Investigational Site 6095	Bucheon-Si
Korea, Republic of	Galderma Investigational Site 6100	Busan
Korea, Republic of	Galderma Investigational Site 6098	Gyeonggi-do
Korea, Republic of	Galderma Investigational Site 6154	Gyeonggi-Do
Korea, Republic of	Galderma Investigational Site 6093	Incheon
Korea, Republic of	Galderma Investigational Site 6120	Incheon
Korea, Republic of	Galderma Investigational Site 6138	Incheon
Korea, Republic of	Galderma Investigational Site 5659	Seoul
Korea, Republic of	Galderma Investigational Site 6056	Seoul
Korea, Republic of	Galderma Investigational Site 6094	Seoul
Korea, Republic of	Galderma Investigational Site 6099	Seoul
Korea, Republic of	Galderma Investigational Site 6103	Seoul
Korea, Republic of	Galderma Investigational Site 6105	Seoul
Korea, Republic of	Galderma Investigational Site 6116	Seoul
Korea, Republic of	Galderma Investigational Site 6129	Seoul
Latvia	Galderma Investigational Site 6113	Liepaja
Latvia	Galderma Investigational Site 6059	Riga
Latvia	Galderma Investigational Site 6134	Riga
Latvia	Galderma Investigational Site 6060	Talsi
Lithuania	Galderma Investigational Site 6111	Kaunas
Lithuania	Galderma Investigational Site 6073	Vilnius
Lithuania	Galderma Investigational Site 6112	Vilnius
Netherlands	Galderma Investigational Site 6212	Groningen
Netherlands	Galderma Investigational Site 6108	Rotterdam
Netherlands	Galderma Investigational Site 6027	Utrecht
New Zealand	Galderma Investigational Site 6119	Hamilton
New Zealand	Galderma Investigational Site 6118	Wellington
Poland	Galderma Investigational Site 5773	Bialystok
Poland	Galderma Investigational Site 6097	Chorzów
Poland	Galderma Investigational Site 6255	Czestochowa
Poland	Galderma Investigational Site 5138	Gdansk
Poland	Galderma Investigational Site 6075	Gdansk
Poland	Galderma Investigational Site 6243	Gdansk
Poland	Galderma Investigational Site 6244	Gdynia
Poland	Galderma Investigational Site 5021	Katowice
Poland	Galderma Investigational Site 6087	Katowice
Poland	Galderma Investigational Site 5362	Kraków
Poland	Galderma Investigational Site 6052	Kraków
Poland	Galderma Investigational Site 5363	Lódz
Poland	Galderma Investigational Site 5570	Lódz
Poland	Galderma Investigational Site 6231	Lódz
Poland	Galderma Investigational Site 6245	Lódz
Poland	Galderma Investigational Site 5367	Lublin
Poland	Galderma Investigational Site 6071	Lublin
Poland	Galderma Investigational Site 5377	Nowa Sól
Poland	Galderma Investigational Site 6063	Olsztyn
Poland	Galderma Investigational Site 6237	Ostrowiec Swietokrzyski
Poland	Galderma Investigational Site 6085	Poznan
Poland	Galderma Investigational Site 6127	Poznan
Poland	Galderma Investigational Site 5495	Rzeszów
Poland	Galderma Investigational Site 6088	Rzeszów
Poland	Galderma Investigational Site 6130	Szczecin
Poland	Galderma Investigational Site 6223	Szczecin
Poland	Galderma Investigational Site 6048	Tarnow
Poland	Galderma Investigational Site 5707	Warsaw
Poland	Galderma Investigational Site 6126	Warsaw
Poland	Galderma Investigational Site 6064	Warszawa
Poland	Galderma Investigational Site 6065	Warszawa
Poland	Galderma Investigational Site 6122	Warszawa
Poland	Galderma Investigational Site 6222	Warszawa
Poland	Galderma Investigational Site 6242	Warszawa
Poland	Galderma Investigational Site 5005	Wroclaw
Poland	Galderma Investigational Site 6047	Wroclaw
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
Spain	Galderma Investigational Site 6057	Alicante
Spain	Galderma Investigational Site 6035	Barcelona
Spain	Galderma Investigational Site 6037	Barcelona
Spain	Galderma Investigational Site 5580	L'Hospitalet De Llobregat
Spain	Galderma Investigational Site 6106	Las Palmas De Gran Canaria
Spain	Galderma Investigational Site 5551	Madrid
Spain	Galderma Investigational Site 5842	Madrid
Spain	Galderma Investigational Site 6036	Madrid
Spain	Galderma Investigational Site 6058	Madrid
Spain	Galderma Investigational Site 6186	Madrid
Spain	Galderma Investigational Site 6190	Madrid
Spain	Galderma Investigational Site 6191	Pamplona
United Kingdom	Galderma Investigational Site 6202	Barnsley
United Kingdom	Galderma Investigational Site 6207	Blackpool
United Kingdom	Galderma Investigational Site 6203	Cannock
United Kingdom	Galderma Investigational Site 6090	Dudley
United Kingdom	Galderma Investigational Site 6104	Glasgow
United Kingdom	Galderma Investigational Site 6204	Liverpool
United Kingdom	Galderma Investigational Site 6121	London
United Kingdom	Galderma Investigational Site 6205	Manchester
United Kingdom	Galderma Investigational Site 6208	Newcastle
United Kingdom	Galderma Investigational Site 6206	Stockton-on-Tees
United States	Galderma Investigational Site 8826	Albuquerque	New Mexico
United States	Galderma Investigational Site 8831	Anaheim	California
United States	Galderma Investigational Site 8743	Ann Arbor	Michigan
United States	Galderma Investigational Site 8133	Arlington	Texas
United States	Galderma Investigational Site 8298	Austin	Texas
United States	Galderma Investigational Site 8882	Bangor	Maine
United States	Galderma Investigational Site 8512	Bay City	Michigan
United States	Galderma Investigational Site 8906	Bell Gardens	California
United States	Galderma Investigational Site 8456	Beverly Hills	California
United States	Galderma Investigational Site 8702	Bexley	Ohio
United States	Galderma Investigational Site 8749	Birmingham	Alabama
United States	Galderma Investigational Site 8893	Birmingham	Alabama
United States	Galderma Investigational Site 8870	Boca Raton	Florida
United States	Galderma Investigational Site 8242	Brooklyn	New York
United States	Galderma Investigational Site 8741	Buffalo	New York
United States	Galderma Investigational Site 8738	Burke	Virginia
United States	Galderma Investigational Site 8805	Cape Coral	Florida
United States	Galderma Investigational Site 8578	Cerritos	California
United States	Galderma Investigational Site 8736	Charleston	South Carolina
United States	Galderma Investigational Site 8777	Charleston	South Carolina
United States	Galderma Investigational Site 9916	Chicago	Illinois
United States	Galderma Investigational Site 8747	Cincinnati	Ohio
United States	Galderma Investigational Site 8786	Clearwater	Florida
United States	Galderma Investigational Site 8667	Columbus	Georgia
United States	Galderma Investigational Site 8723	Cortland	New York
United States	Galderma Investigational Site 8238	Dallas	Texas
United States	Galderma Investigational Site 8245	Dallas	Texas
United States	Galderma Investigational Site 8554	Detroit	Michigan
United States	Galderma Investigational Site 8902	Doral	Florida
United States	Galderma Investigational Site 8827	Dripping Springs	Texas
United States	Galderma Investigational Site 8595	Dublin	Ohio
United States	Galderma Investigational Site 8772	Durham	North Carolina
United States	Galderma Investigational Site 8577	Encinitas	California
United States	Galderma Investigational Site 8862	Fairfax	Virginia
United States	Galderma Investigational Site 8637	Farmington	Connecticut
United States	Galderma Investigational Site 8617	Farmington Hills	Michigan
United States	Galderma Investigational Site 8828	Forest Hills	New York
United States	Galderma Investigational Site 8447	Fort Smith	Arkansas
United States	Galderma Investigational Site 8636	Fountain Valley	California
United States	Galderma Investigational Site 8224	Fremont	California
United States	Galderma Investigational Site 8791	Fresno	California
United States	Galderma Investigational Site 8664	Frisco	Texas
United States	Galderma Investigational Site 8888	Fullerton	California
United States	Galderma Investigational Site 9925	Glendale	New York
United States	Galderma Investigational Site 8866	Guntersville	Alabama
United States	Galderma Investigational Site 8506	Hackensack	New Jersey
United States	Galderma Investigational Site 8740	Henderson	Nevada
United States	Galderma Investigational Site 8391	Hialeah	Florida
United States	Galderma Investigational Site 8804	Hialeah	Florida
United States	Galderma Investigational Site 8042	Houston	Texas
United States	Galderma Investigational Site 8670	Houston	Texas
United States	Galderma Investigational Site 8807	Houston	Texas
United States	Galderma Investigational Site 8845	Huntington Beach	California
United States	Galderma Investigational Site 8142	Indianapolis	Indiana
United States	Galderma Investigational Site 8833	Inglewood	California
United States	Galderma Investigational Site 8711	Jacksonville	Florida
United States	Galderma Investigational Site 8836	Jacksonville	Florida
United States	Galderma Investigational Site 8817	Katy	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 8109	Lebanon	New Hampshire
United States	Galderma Investigational Site 8686	Lomita	California
United States	Galderma Investigational Site 8674	Los Angeles	California
United States	Galderma Investigational Site 8683	Los Angeles	California
United States	Galderma Investigational Site 8813	Los Angeles	California
United States	Galderma Investigational Site 8771	Louisville	Kentucky
United States	Galderma Investigational Site 8744	Macon	Georgia
United States	Galderma Investigational Site 8850	Margate	Florida
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 8708	Miami	Florida
United States	Galderma Investigational Site 8719	Miami	Florida
United States	Galderma Investigational Site 8737	Miami	Florida
United States	Galderma Investigational Site 8801	Miami	Florida
United States	Galderma Investigational Site 8851	Miami	Florida
United States	Galderma Investigational Site 8800	Miami Lakes	Florida
United States	Galderma Investigational Site 8806	Miami Lakes	Florida
United States	Galderma Investigational Site 8718	Missoula	Montana
United States	Galderma Investigational Site 8819	Nampa	Idaho
United States	Galderma Investigational Site 8724	New Albany	Indiana
United States	Galderma Investigational Site 8279	New York	New York
United States	Galderma Investigational Site 8620	New York	New York
United States	Galderma Investigational Site 8733	New York	New York
United States	Galderma Investigational Site 8728	Newnan	Georgia
United States	Galderma Investigational Site 8907	Newport Beach	California
United States	Galderma Investigational Site 8739	Normal	Illinois
United States	Galderma Investigational Site 8206	Norman	Oklahoma
United States	Galderma Investigational Site 8713	North Charleston	South Carolina
United States	Galderma Investigational Site 8880	North Little Rock	Arkansas
United States	Galderma Investigational Site 8857	Oklahoma City	Oklahoma
United States	Galderma Investigational Site 8810	Omaha	Nebraska
United States	Galderma Investigational Site 8799	Ontario	California
United States	Galderma Investigational Site 8856	Ormond Beach	Florida
United States	Galderma Investigational Site 8745	Pasadena	California
United States	Galderma Investigational Site 8734	Pembroke Pines	Florida
United States	Galderma Investigational Site 8255	Philadelphia	Pennsylvania
United States	Galderma Investigational Site 8721	Pittsburgh	Pennsylvania
United States	Galderma Investigational Site 8787	Plano	Texas
United States	Galderma Investigational Site 8802	Plymouth Meeting	Pennsylvania
United States	Galderma Investigational Site 8212	Portland	Oregon
United States	Galderma Investigational Site 8818	Rapid City	South Dakota
United States	Galderma Investigational Site 8896	Richmond	Virginia
United States	Galderma Investigational Site 8729	Rolling Meadows	Illinois
United States	Galderma Investigational Site 8521	Saint Joseph	Missouri
United States	Galderma Investigational Site 8672	Salt Lake City	Utah
United States	Galderma Investigational Site 8329	San Antonio	Texas
United States	Galderma Investigational Site 8658	San Diego	California
United States	Galderma Investigational Site 8671	San Diego	California
United States	Galderma Investigational Site 8692	San Diego	California
United States	Galderma Investigational Site 8125	San Francisco	California
United States	Galderma Investigational Site 8536	Santa Ana	California
United States	Galderma Investigational Site 8608	Santa Monica	California
United States	Galderma Investigational Site 8808	Scottsdale	Arizona
United States	Galderma Investigational Site 8873	Scottsdale	Arizona
United States	Galderma Investigational Site 8434	Seattle	Washington
United States	Galderma Investigational Site 9934	Shawnee Mission	Kansas
United States	Galderma Investigational Site 8795	Shelby	North Carolina
United States	Galderma Investigational Site 8712	Skokie	Illinois
United States	Galderma Investigational Sites 8571	Skokie	Illinois
United States	Galderma Investigational Site 8707	Stockbridge	Georgia
United States	Galderma Investigational Site 8203	Tampa	Florida
United States	Galderma Investigational Site 8816	Tampa	Florida
United States	Galderma Investigational Site 8839	Tampa	Florida
United States	Galderma Investigational Site 8889	Tampa	Florida
United States	Galderma Investigational Site 8155	Troy	Michigan
United States	Galderma Investigational Site 8849	Troy	Michigan
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
United States	Galderma Investigational Site 8648	Wilmington	North Carolina
United States	Galderma Investigational Site 8726	Wilmington	North Carolina
United States	Galderma Investigational Site 8748	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Czechia,  Estonia,  France,  Georgia,  Germany,  Hungary,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Netherlands,  New Zealand,  Poland,  Singapore,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and Severity of TEAEs		Baseline to Week 200
Primary	Incidence of Serious TEAEs		Baseline to Week 200
Primary	Incidence and Severity of Adverse Events of Special Interest (AESIs) Throughout the Study		Baseline to Week 200
Secondary	Proportion of Participants with IGA score = 0-1 at Each Visit		Baseline to Week 200
Secondary	Proportion of Participants with EASI-75 at Each Visit		Baseline to Week 200
Secondary	Change and Percent Change From Baseline in Overall Eczema Area and Severity Index (EASI) Score at Each Visit	EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity will be assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score can range from 0 to 72 with higher scores representing greater severity of atopic dermatitis.	Baseline to Week 200
Secondary	Proportion of Participants with IGA = 2 at Each Visit		Baseline to Week 200
Secondary	Change and Percent Change From Baseline in SCORAD Score at Each Visit		Baseline to Week 200
Secondary	Change and Percent Change From Baseline in Participant-Reported Pruritus Using 10-cm VAS (SCORAD Sub-Component)		Baseline to Week 200
Secondary	Change and Percent Change From Baseline in Participant-Reported Sleep Loss Using 10-cm VAS (SCORAD Sub-Component)		Baseline to Week 200
Secondary	Proportion of Participants Reporting Low Disease Activity State Based on PGAD at Each Visit		Baseline to Week 200
Secondary	Proportion of Participants Satisfied with Study Treatment Based on PGAT at each visit		Baseline to Week 200
Secondary	Change from Baseline in Dermatology Life Quality Index (DLQI)		Baseline to Week 200
Secondary	Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) Total Score at Each Visit Through Week 200		Baseline to Week 200
Secondary	Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Each Visit Through Week 200		Baseline to Week 200
Secondary	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) for Each Subscale at Each Visit Through Week 200		Baseline to Week 200
Secondary	Change From Baseline in Work Productivity and Activity Impairment: Atopic Dermatitis (WPAI:AD) for Each Subscale at Each Visit Through Week 200		Baseline to Week 200
Secondary	Change From Baseline in EuroQoL 5-Dimension (EQ-5D) at Each Visit Through Week 200		Baseline to Week 200
Secondary	Proportion of Participants Receiving Any Rescue Therapy by Rescue Treatment Type at Any Visit During the Treatment Period		Baseline to Week 200
Secondary	Time to First Relapse		Baseline to Week 200
Secondary	Duration of Remission		Baseline to Week 200
Secondary	Time to Permanent Study Drug Discontinuation		Baseline to Week 200