In short
Clinical trials are investigating Sar441566 in adults with plaque psoriasis and rheumatoid arthritis. These studies look at whether Sar441566 can improve disease signs and whether it is safe and effective compared with placebo, sometimes with methotrexate. Both trials are phase 2 studies in adults with moderate to severe disease.
Key points
- Sar441566 is being studied in two completed Phase 2 clinical trials in adults. One trial looks at moderate to severe plaque psoriasis, and the other looks at moderate to severe rheumatoid arthritis. The psoriasis study compares Sar441566 with placebo and measures PASI75 at week 12. The rheumatoid arthritis study compares Sar441566 with placebo, with methotrexate also included, and measures ACR20 at week 12. Together, these trials focus on whether Sar441566 can improve disease signs in these patient groups.
Trial overview
Two interventional studies investigated Sar441566 in adults with inflammatory diseases. Both studies were Phase 2 and both were completed.
One study focused on plaque psoriasis, and the other focused on rheumatoid arthritis. These trials were designed to see whether Sar441566 could improve disease signs and how it compared with placebo.
Plaque psoriasis study
The psoriasis trial was titled “A study to evaluate efficacy and safety of SAR441566 in adults with plaque psoriasis.” It enrolled 490 people and was completed.
This study included adults with moderate to severe plaque psoriasis in the Naïve Targeted Immunotherapy Population (NTIP). “Naïve” means the people had not used the targeted immunotherapy approach studied here before.
The main goal was to show that Sar441566 was better than placebo. The key outcome was the number of participants who had at least a 75% improvement in the Psoriasis Area and Severity Index score, called PASI75, at week 12.
Rheumatoid arthritis study
The rheumatoid arthritis trial was titled “A study to evaluate SAR441566 efficacy and safety in adults with rheumatoid arthritis.” It enrolled 821 people and was completed.
This study included adults with moderate-to-severe rheumatoid arthritis. It compared Sar441566 with placebo, and methotrexate was also part of the study treatment plan.
The brief summary says the study aimed to show that Sar441566, described in the trial record as a small molecule specific inhibitor of TNFR1 signaling, was effective when used with methotrexate. The main outcome was the number of participants who reached at least a 20% improvement in the American College of Rheumatology score, called ACR20, at week 12.
Outcomes and measures
Both studies used a 12-week primary outcome time point. This means the main results were measured after 12 weeks of treatment.
In psoriasis, the main measure was PASI75, which shows a large improvement in skin symptoms. In rheumatoid arthritis, the main measure was ACR20, which shows improvement in joint disease signs and symptoms.
Who participated
Both trials were for adults. The psoriasis study looked at adults with moderate to severe plaque psoriasis, while the arthritis study looked at adults with moderate to severe rheumatoid arthritis.
The trial data do not give more detailed entry rules such as age limits, prior treatments, or lab test requirements.
What the results mean
These studies were built to test whether Sar441566 could help people with two different inflammatory diseases. Because both trials are completed, the records show the study goals and endpoints, but they do not provide detailed outcome results in the source data used here.
For patients, the most important point is that Sar441566 was studied in separate Phase 2 trials for skin disease and joint disease, with clear measures of improvement at week 12.