Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Afimkibart Group I 		Participants will receive Afimkibart as subcutaneous (SC) injection.
  • Drug: Afimkibart
    Afimkibart SC injection will be administered as per the schedule defined in the protocol.
    Other names:
    • RO7790121
    • PF-06480605
    • RVT-3101
Experimental
Afimkibart Group II 		Participants will receive Afimkibart as SC injection.
  • Drug: Afimkibart
    Afimkibart SC injection will be administered as per the schedule defined in the protocol.
    Other names:
    • RO7790121
    • PF-06480605
    • RVT-3101

Recruiting Locations

Hamilton Research, LLC
Alpharetta, Georgia 30022

Revival Research Institute, LLC
Troy, Michigan 48084

Best Skin Research LLC
Camp Hill, Pennsylvania 17011

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: CS45943 https://forpatients.roche.com/ No attachments to email below.
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.