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

Roche

Status and phase: Enrolling; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Afimkibart

Study type: Interventional

Funder types: Industry

Identifiers

NCT07223697

CS45943

2025-520771-59-00 (EU Trial (CTIS) Number)

Details and patient eligibility

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

Afimkibart Group I

Experimental group

Description:

Participants will receive Afimkibart as subcutaneous (SC) injection.

Treatment:

Drug: Afimkibart

Afimkibart Group II

Experimental group

Description:

Participants will receive Afimkibart as SC injection.

Treatment:

Drug: Afimkibart