A Study to Assess the Efficacy and Safety of RO7790121 in Patients with Moderate to Severe Rheumatoid Arthritis who have not Responded to or who Cannot Tolerate TNF and/or JAK Inhibitors

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]

Trial duration

5 Dec 2025 → ongoing

Decision date (initial)

2025-11-25

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 efficacy of RO7790121 compared with placebo with respect to change from baseline in Disease Activity Score-28 C-Reactive Protein (DAS28-CRP) at Week 14

Secondary objectives 3

1. To evaluate the efficacy of RO7790121 compared with placebo using American College of Rheumatology 20 (ACR20), ACR50 and ACR70 response rate at Week 14
2. To evaluate the safety of RO7790121 compared with placebo
3. To characterize the pharmacokinetic (PK) of RO7790121

Conditions and MedDRA coding

Moderate to Severe Rheumatoid Arthritis (RA)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Have moderate to severe active RA defined by the presence of ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline (based on 66/68-joint count)
2. Agreement to adhere to the contraception requirements
3. Diagnosis of RA for ≥ 3 months and also fulfills the 2010 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) classification criteria for RA
4. Demonstrated an inadequate response or loss of response to or intolerance to one or more TNF/JAK inhibitor(s)

Exclusion criteria 4

1. Class IV RA according to ACR revised response criteria
2. Any major surgery within 6 weeks prior to screening or a major surgery planned during the study
3. History of organ transplant
4. Acquired or congenital immunodeficiency

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in DAS28-CRP at Week 14

Secondary endpoints 9

1. ACR20 response rate at Week 14
2. ACR50 response rate at Week 14
3. ACR70 response rate at Week 14
4. Change from baseline in DAS28-ESR at Week 14
5. Change from baseline in SDAI score at Week 14
6. Change from baseline in CDAI score at Week 14
7. Change from baseline in SF-36 score at Week 14
8. Incidence and severity of the following: - Adverse events - Serious adverse events - Adverse events leading to study treatment discontinuation - Adverse events of special interest - Change from baseline in selected vital signs - Change from baseline in selected clinical laboratory test results
9. Serum concentration of RO7790121 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 10

Locations

7 EU/EEA countries · 33 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 60 files

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

Application history

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