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Not recruiting
Phase 2

Afimkibart

Sponsor:

Hoffmann-La Roche

Code:

NCT07223697

Conditions

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Afimkibart

Study Details

Brief summary:

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.

Conditions

Atopic Dermatitis

Study ID

NCT07223697

Start date

Jan 8, 2026

Status verified date

Oct, 2026

Completion date

Mar 1, 2033

Anticipated

Primary completion date

Mar 1, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Afimkibart Group I

Participants will receive Afimkibart as subcutaneous (SC) injection.

experimental: Afimkibart Group II

Participants will receive Afimkibart as SC injection.

Interventions

Afimkibart

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

Primary outcome measure

  • Percentage of Participants with Adverse Events [ Time Frame: From Baseline up to 6 years ]

Central Contacts and Locations

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-02. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.