A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Recruiting · NCT07223697 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Ability and willingness to comply with all aspects of the protocol including completion of the efficacy assessments (EASI and IGA), clinical outcome assessment instruments (DLQI, POEM), and safety and PK sample collections for the duration of the study
- Parent Clinical Trial-Specific Criteria:
- Study CS45570 participants who continued to be evaluated at the Week 36 follow up visit and achieved =\> EASI50 response from study baseline
Exclusion criteria
- Evidence of other skin conditions that would interfere with the assessment of AD
- Withdrawal of consent and/or premature discontinuation from parent study
- Any permanent discontinuation of study drug in parent study
- History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of Afimkibart
Where it is running
29 locations listed across 5 US states.
- UCLA Division of Dermatology - Los Angeles, California, United States
- Dermatology Research Associate - Los Angeles, California, United States
- Olympian Clinical Research - Tampa, Florida, United States
- Hamilton Research, LLC - Alpharetta, Georgia, United States
- Revival Research Institute, LLC - Troy, Michigan, United States
- Best Skin Research LLC - Camp Hill, Pennsylvania, United States
- Hospital Universitario Reina Sofia - Córdoba, Spain
- Centrum Medyczne Pratia Gdynia - Gdynia, Poland
- Dermatologikum Hamburg Gemeinschaftspraxis GbR - Hamburg, Germany
- Specjalistyczny Gabinet Dermatologiczny dr n. med. Pawel Brzewski - Krakow, Poland
- Centrum Nowoczesnych Terapii "Dobry Lekarz" - Krakow, Poland
- Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A - Rio de Janeiro, Brazil
- Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie - Rzeszów, Poland
- Klinika Ambroziak Dermatologia - Warsaw, Poland
- Fachklinik Bad Bentheim - Bad Bentheim, Lower Saxony, Germany
- Clinica Universidad de Navarra - Pamplona, Navarre, Spain
- DermEffects - London, Ontario, Canada
- Lynderm Research Inc - Markham, Ontario, Canada
- DermEdge - Mississauga, Ontario, Canada
- Ryan Clinical Research Inc - Newmarket, Ontario, Canada
- Centro de Estudos em Terapias Inovadoras ? CETI - Curitiba, Paraná, Brazil
- Irmandade Da Santa Casa de Misericordia de Porto Alegre - Porto Alegre, Rio Grande do Sul, Brazil
- Hospital de Clnicas de Porto Alegre - Porto Alegre, Rio Grande do Sul, Brazil
- Centrum Medyczne Pratia Katowice I - Katowice, Silesian Voivodeship, Poland
- UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu - Botucatu, São Paulo, Brazil
- Centro de Pesquisa São Lucas - Campinas, São Paulo, Brazil
- HMCG - Hospital e Maternidade Dr. Christovo da Gama - Santo Andr, São Paulo, Brazil
- Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS - Sao Jose Rio Preto, São Paulo, Brazil
- Azienda Ospedaliero Universitaria delle Marche - Ancona, The Marches, Italy