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

ConditionAtopic Dermatitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Study CS45570 participants who continued to be evaluated at the Week 36 follow up visit and achieved => EASI50 response from study baseline

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Afimkibart

    Drug

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Afimkibart Group IExperimental treatment 1 intervention
Group B: Afimkibart Group IIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants with Adverse Events

Time frame
From Baseline up to 6 years

Secondary outcomes

1

Change From Baseline (in Parent Study) in Eczema Area and Severity Index (EASI) Score at Each Visit

Time frame
Baseline, Up to 6 years
2

Percent Change From Baseline (in Parent Study) in EASI Score at Each Visit

Time frame
Baseline, Up to 6 years
3

Percentage of Participants With EASI-50 at Each Visit

Time frame
Up to 6 years
4

Percentage of Participants with EASI-75 at Each Visit

Time frame
Up to 6 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
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