Clinical trial · Interventional
A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Study to Evaluate The Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-alpha Inhibitors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The trial was prematurely terminated due to a lack of efficacy of the investigational drug.
Summary
Brief summary (as posted)
This is a Phase IIa/b double-blind, placebo-controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of RO7123520 as adjunctive therapy in participants with RA who are inadequately responding to standard-of-care (methotrexate and anti-TNF-alpha therapy). Part 1 of the study will evaluate safety. Part 2 will evaluate efficacy and safety. Part 3 will evaluate dose-ranging efficacy. Participants will have the option of continuing to the extension period of the study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-TNF-alpha | Drug | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| RO7123520 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- PLACEBO_COMPARATOR
- label
- Part 1: Placebo
- description
- Participants will receive placebo (matched to RO7123520) on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.
- interventionNames
- Drug: Anti-TNF-alpha
- Drug: Methotrexate
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Part 1: RO7123520
- description
- Participants will receive RO7123520 on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.
- interventionNames
- Drug: Anti-TNF-alpha
- Drug: Methotrexate
- Drug: RO7123520
- type
- PLACEBO_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of adult-onset RA as defined by the ACR 2010 criteria, for at least 6 months before screening * Moderately to severely active RA as defined by at least 4/28 tender joints and at least 4/28 swollen joints, and a DAS28 greater than or equal to (≥) 3.2 * For Part 2 only: Active synovitis and/or osteitis as determined by contrast-enhanced magnetic resonance imaging * Participants must be taking stable dose of anti-TNF-alpha therapies * Participants on stable oral glucocorticoids within 6 weeks of planned randomization * Participants taking non-steroidal anti-inflammatory drugs (NSAIDs) intermittently (up to 2-3 times weekly) for short-term relief of pain and participants on regular NSAID use (on stable dose for ≥ 4 weeks) Exclusion Criteria: * Parenteral glucocorticoids administration (intramuscular, IV) of ≥50 mg within 6 weeks or less than or equal to (≤) 50 milligrams (mg) within 4 weeks prior to planned randomization, or scheduled parenteral administrations during the study * Joint(s) injected with intra-articular glucocorticoids or hyaluronic acid within 6 weeks prior to planned randomization * Active inflammatory diseases of the joints not related to RA * Systemic autoimmune disease other than RA * Juvenile idiopathic arthritis or juvenile RA and/or RA developed before the age of 16 * Active fibromyalgia that makes appropriate assessment of RA disease activity challenging in the opinion of the Investigator * RA participants functional status class IV according to the ACR 1991 criteria * Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections * History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection * Any identified confirmed congenital or acquired immunodeficiency * Abnormal laboratory values and liver function test * Myocardial infarction within less than 6 months prior to participation in the study * Severe central or peripheral nervous system diseases
References
Publications (0)
Data not yet available