A Study to Assess the Long-Term Efficacy and Safety of Afimkibart (RO7790121) in Patients with Atopic Dermatitis who participated in previous Afimkibart Clinical Trials

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17], Phenomena and Processes [G] - Immune System Phenomena [G13]

Trial duration

3 Feb 2026 → ongoing

Decision date (initial)

2026-01-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann-La Roche Ltd

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic

To evaluate the long-term safety and tolerability of afimkibart

Secondary objectives 5

1. To monitor the long-term efficacy of afimkibart
2. To monitor the long-term efficacy of afimkibart in achieving improvement in PROs
3. To evaluate the safety of afimkibart
4. To characterize PK of afimkibart
5. To evaluate the immunogenicity of afimkibart

Conditions and MedDRA coding

Atopic Dermatitis

Regulatory references

Plan to share IPD

No

IPD plan description

N/A

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 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
2. Agreement to adhere to the contraception requirements
3. Completed the treatment period of the parent study

Exclusion criteria 6

1. Evidence of other skin conditions that would interfere with the assessment of AD, including, but not limited to, for example cutaneous T-cell lymphoma, allergic contact dermatitis
2. Withdrawal of consent and/or premature discontinuation from parent study
3. Any permanent discontinuation of study drug in parent study
4. Use of a prohibited therapy during the parent study
5. Investigator determination that treatment discontinuation is in the best interest of the participant
6. History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of afimkibart

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence and severity of adverse events, serious adverse events, adverse events leading to study treatment discontinuation, adverse events of special interest

Secondary endpoints 9

1. Change and percent change from baseline (in parent study) in Eczema Area and Severity Index (EASI) score at each visit
2. Proportion of participants with EASI50/75/90 at each visit
3. Proportion of participants achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) of clear (0) or almost clear (1) with more than or equal to 2-grade improvement from baseline (in the parent study) at each visit
4. Change from parent baseline (in the parent study) in Participant-Oriented Eczema Measure (POEM) at each visit
5. Change from parent baseline (in the parent study) in Dermatology Life Quality Index (DLQI) at each visit
6. Change from baseline (in the parent study) in selected clinical laboratory test results
7. Change from baseline in selected vital signs
8. Serum concentration of afimkibart at specified timepoints
9. Incidence and titres of ADA and NAb

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 7

Locations

5 EU/EEA countries · 29 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 30 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications