Trial results for the Phase 2 study (NCT06028438) evaluating nipocalimab in combination with certolizumab for participants with active rheumatoid arthritis were posted on ClinicalTrials.gov on 2025-10-16. The study aimed to compare the efficacy of combination therapy versus certolizumab monotherapy. While some numerical improvements were observed with the combination, the ANCOVA analysis for the change from baseline in Disease Activity Index Score 28 using C-reactive Protein (DAS28-CRP) at Week 12 showed no statistically significant difference, with a least square mean difference of -0.06 (p-value: 0.822).
Background
The study, titled "A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis," investigated the potential benefits of adding nipocalimab to existing certolizumab treatment for individuals suffering from active rheumatoid arthritis. Rheumatoid arthritis is a chronic autoimmune disease characterized by inflammation in the joints.
Trial design
The study (NCT06028438) was a Phase 2, completed trial that enrolled 103 participants with active rheumatoid arthritis. The trial evaluated combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy (which included placebo in the combination arm). The purpose of this study was to evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy.
Key results
The trial assessed several outcome measures at Week 12. For the "Change From Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12":
- Participants in the Certolizumab and Placebo group showed a least squares mean change of -1.86.
- Participants in the Certolizumab and Nipocalimab group showed a least squares mean change of -1.92.
An ANCOVA analysis comparing the two groups for this outcome showed a least square mean difference of -0.06 (95.0% Confidence Interval: -0.6 to 0.48) with a p-value of 0.822.
Regarding "Percentage of Participants Who Achieved American College of Rheumatology (ACR) Response at Week 12":
- ACR20 Response: 63.4% of participants in the Certolizumab and Placebo group achieved ACR20, compared to 62.9% in the Certolizumab and Nipocalimab group.
- ACR50 Response: 31.71% of participants in the Certolizumab and Placebo group achieved ACR50, compared to 40.32% in the Certolizumab and Nipocalimab group.
- ACR70 Response: 12.20% of participants in the Certolizumab and Placebo group achieved ACR70, compared to 14.52% in the Certolizumab and Nipocalimab group.
- ACR90 Response: 2.44% of participants in the Certolizumab and Placebo group achieved ACR90, compared to 3.23% in the Certolizumab and Nipocalimab group.
For "Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Remission at Week 12":
- 14.63% of participants in the Certolizumab and Placebo group achieved remission.
- 25.81% of participants in the Certolizumab and Nipocalimab group achieved remission.
What this means
The Phase 2 trial results indicate that the addition of nipocalimab to certolizumab therapy for active rheumatoid arthritis did not lead to a statistically significant improvement in the change from baseline in DAS28-CRP score at Week 12, as evidenced by the p-value of 0.822. While some numerical trends, such as higher rates of ACR50, ACR70, ACR90 responses, and DAS28-CRP remission, were observed in the combination therapy group, these were not statistically supported by the primary analysis for DAS28-CRP change. Further investigation would be needed to determine the clinical relevance of these numerical differences.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT06028438, titled "A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis," were posted on 2025-10-16 on clinicaltrials.gov.