Table of Contents
- Trial overview
- Plaque psoriasis study
- Rheumatoid arthritis study
- Outcomes and measures
- Who participated
- What the results mean
Trial overview
Two interventional studies investigated Sar441566 in adults with inflammatory diseases.[1][2] Both studies were Phase 2 and both were completed.[1][2]
One study focused on plaque psoriasis, and the other focused on rheumatoid arthritis.[1][2] These trials were designed to see whether Sar441566 could improve disease signs and how it compared with placebo.[1][2]
Plaque psoriasis study
The psoriasis trial was titled “A study to evaluate efficacy and safety of SAR441566 in adults with plaque psoriasis.”[1] It enrolled 490 people and was completed.[1]
This study included adults with moderate to severe plaque psoriasis in the Naïve Targeted Immunotherapy Population (NTIP).[1] “Naïve” means the people had not used the targeted immunotherapy approach studied here before.[1]
The main goal was to show that Sar441566 was better than placebo.[1] 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.[1]
Rheumatoid arthritis study
The rheumatoid arthritis trial was titled “A study to evaluate SAR441566 efficacy and safety in adults with rheumatoid arthritis.”[2] It enrolled 821 people and was completed.[2]
This study included adults with moderate-to-severe rheumatoid arthritis.[2] It compared Sar441566 with placebo, and methotrexate was also part of the study treatment plan.[2]
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.[2] 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.[2]
Outcomes and measures
Both studies used a 12-week primary outcome time point.[1][2] This means the main results were measured after 12 weeks of treatment.[1][2]
In psoriasis, the main measure was PASI75, which shows a large improvement in skin symptoms.[1] In rheumatoid arthritis, the main measure was ACR20, which shows improvement in joint disease signs and symptoms.[2]
Who participated
Both trials were for adults.[1][2] 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.[1][2]
The trial data do not give more detailed entry rules such as age limits, prior treatments, or lab test requirements.[1][2]
What the results mean
These studies were built to test whether Sar441566 could help people with two different inflammatory diseases.[1][2] 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.[1][2]
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.[1][2]
