Menu
Recruiting NCT07223697

A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis

Phase II Interventional Atopic Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Afimkibart.
Who it may be relevant to
Registry conditions: Atopic Dermatitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Brazil, Canada, Germany, Italy +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Extension Study To Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients With Atopic Dermatitis Who Participated in Previous Afimkibart Clinical Trials

Overview

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.

Interventions

  • Drug Afimkibart
    Afimkibart SC injection will be administered as per the schedule defined in the protocol.

Primary outcome measures

  • Percentage of Participants with Adverse Events [Time frame: From Baseline up to 6 years]
Secondary outcome measures (11)
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Brazil · 8 centers
  • Centro de Estudos em Terapias Inovadoras ? CETI — Curitiba
  • Irmandade Da Santa Casa de Misericordia de Porto Alegre — Porto Alegre
  • Hospital de Clnicas de Porto Alegre — Porto Alegre
  • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu — Botucatu
  • Centro de Pesquisa São Lucas — Campinas
  • HMCG - Hospital e Maternidade Dr. Christovo da Gama — Santo Andr
  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS — Sao Jose Rio Preto
  • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A — Rio de Janeiro
Poland · 6 centers
  • Centrum Medyczne Pratia Katowice I — Katowice
  • Centrum Medyczne Pratia Gdynia — Gdynia
  • Specjalistyczny Gabinet Dermatologiczny dr n. med. Pawel Brzewski — Krakow
  • Centrum Nowoczesnych Terapii "Dobry Lekarz" — Krakow
  • Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie — Rzeszów
  • Klinika Ambroziak Dermatologia — Warsaw
United States · 5 centers
  • UCLA Division of Dermatology — Los Angeles
  • Olympian Clinical Research — Tampa
  • Hamilton Research, LLC — Alpharetta
  • Revival Research Institute, LLC — Troy
  • Best Skin Research LLC — Camp Hill
Canada · 4 centers
  • DermEffects — London
  • Lynderm Research Inc — Markham
  • DermEdge — Mississauga
  • Ryan Clinical Research Inc — Newmarket
Germany · 2 centers
  • Fachklinik Bad Bentheim — Bad Bentheim
  • Dermatologikum Hamburg Gemeinschaftspraxis GbR — Hamburg
Spain · 2 centers
  • Clinica Universidad de Navarra — Pamplona
  • Hospital Universitario Reina Sofia — Córdoba
Italy · 1 center
  • Azienda Ospedaliero Universitaria delle Marche — Ancona

Identifiers

NCT: NCT07223697 · CS45943 · 2025-520771-59-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗