This study will assess long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with Atopic Dermatitis (AD) who participated in previous afimkibart clinical trials.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Afimkibart SC injection will be administered as per the schedule defined in the protocol.
Percentage of Participants with Adverse Events
Time frame: From Baseline up to 6 years
Change From Baseline (in Parent Study) in Eczema Area and Severity Index (EASI) Score at Each Visit
Time frame: Baseline, Up to 6 years
Percent Change From Baseline (in Parent Study) in EASI Score at Each Visit
Time frame: Baseline, Up to 6 years
Percentage of Participants With EASI-50 at Each Visit
Time frame: Up to 6 years
Percentage of Participants with EASI-75 at Each Visit
Time frame: Up to 6 years
Percentage of Participants with EASI-90 at Each Visit
Time frame: Up to 6 years
Percentage of Participants who Achieve Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) of Clear (0) or Almost clear (1) at Each Visit
Time frame: From Baseline up to 6 years
Change from Baseline (in the parent study) in Participant-Oriented Eczema Measure (POEM) at Each Visit
Time frame: Baseline, Up to 6 years
Change from Baseline (in the parent study) in Dermatology Life Quality Index (DLQI) at Each Visit
Time frame: Baseline, Up to 6 years
Serum Concentration of Afimkibart at Specified Timepoints
Time frame: Pre-dose on Day 1, Weeks 2, 10, 18, 26, 34, 42, 50 74, 98, 122, 146, 170, 194, 218, 242, 266, 290 and 14 weeks after last dose
Reference Study ID Number: CS45943 https://forpatients.roche.com/ No attachments to email below.
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UCLA Division of Dermatology
Los Angeles, California, United States
RECRUITINGDermatology Research Associate
Los Angeles, California, United States
RECRUITINGOlympian Clinical Research
Tampa, Florida, United States
RECRUITINGHamilton Research, LLC
Alpharetta, Georgia, United States
RECRUITINGRevival Research Institute, LLC
Troy, Michigan, United States
RECRUITINGBest Skin Research LLC
Camp Hill, Pennsylvania, United States
RECRUITINGCentro de Estudos em Terapias Inovadoras ? CETI
Curitiba, Paraná, Brazil
RECRUITINGIrmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGHospital de Clnicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGUNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, São Paulo, Brazil
RECRUITING...and 19 more locations
Percentage of Participants with Anti-Drug Antibodies (ADAs) to Afimkibart
Time frame: From Baseline up to 6 years
Percentage of Participants with Neutralizing Antibody (NAb) to Afimkibart
Time frame: From Baseline up to 6 years