An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants with Rheumatoid Arthritis

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] - Immune System Diseases [C20], Phenomena and Processes [G] - Immune System Phenomena [G13]

Decision date (initial)

2026-05-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann-La Roche AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Safety

To evaluate the long-term safety and tolerability of afimkibart

Secondary objectives 3

1. To monitor the long-term efficacy of afimkibart
2. To evaluate the safety of afimkibart
3. To characterize Pharmacokinetics (PK) of afimkibart

Conditions and MedDRA coding

moderate to severe rheumatoid arthritis (RA)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Completed the treatment period of the parent study
2. Agreement to adhere to the contraception requirements
3. Continued to be evaluated at the follow-up visit of the parent study and achieved ≥ 20%improvement in the Swollen Joint Count (SJC)66/ Tender Joint Count (TJC)68 relative to baseline

Exclusion criteria 4

1. Withdrawal of consent and/or premature discontinuation from parent study
2. Any permanent discontinuation of study drug in parent study
3. Use of a prohibited therapy during the parent study
4. Evidence of any new or uncontrolled concomitant disease that, in the investigator’s judgment, would preclude participant participation in the trial

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 6

1. Proportion of participants with American College of Rheumatology ACR20, ACR50, and ACR70 response (improvements will be assessed using the baseline of the parent study)
2. Change from baseline DAS28-CRP)
3. Proportion of participants achieving LDA, CR based on DAS28-CRP, DAS28-ESR, CDAI, or SDAI
4. Change from baseline in selected clinical laboratory test results
5. Change from baseline in selected vital signs
6. Serum concentration of afimkibart at specified timepoints

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 8

Locations

7 EU/EEA countries · 31 investigational sites

By country

Investigational sites

Results and documents

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

Documents 42 files

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

Application history

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