In short
Clinical trials are investigating Sar442970 in adults with ulcerative colitis, Crohn’s disease, and hidradenitis suppurativa. These studies look at whether it is effective and safe, and they measure outcomes such as clinical remission and endoscopic response. Most trials are Phase 2 studies in adult participants.
Key points
- Clinical trials are studying Sar442970 in adults with ulcerative colitis, Crohn’s disease, and hidradenitis suppurativa. All listed studies are Phase 2 trials, which means they are testing whether the treatment may work and how safe it is in larger patient groups. The ulcerative colitis study looks at clinical remission at Week 16. The Crohn’s disease study measures endoscopic response at Week 16. The hidradenitis suppurativa study looks at HiSCR50 in adults who were biologic and small molecule immunosuppressive-naïve. One study is completed, and two are authorised.
Trial overview
These studies are investigating Sar442970 in adults with three different diseases: ulcerative colitis, Crohn’s disease, and hidradenitis suppurativa.
All three are Phase 2 interventional trials, which means the treatment is being tested in people to learn more about whether it may help and how safe it is in the study setting.
The studies compare Sar442970 with a placebo, which is a look-alike treatment with no active study drug.
Ulcerative colitis study
The ulcerative colitis trial is titled as a study to investigate the efficacy and safety of brivekimig in adult participants with ulcerative colitis, and the intervention listed is Sar442970.
This study is authorised, is in Phase 2, and plans to enroll 165 participants.
The brief summary says the study is assessing different dose regimens of brivekimig to induce clinical remission in participants with moderate to severe ulcerative colitis.
The main endpoint is the proportion of participants who achieve clinical remission at Week 16 by mMS, which is a study score based on symptoms and endoscopy findings.
In this study, clinical remission means an mMS score of 0 to 2, with specific limits for stool frequency, rectal bleeding, and endoscopic appearance, and the result must be confirmed by a central reader.
Crohn’s disease study
The Crohn’s disease trial is titled as a study to investigate efficacy and safety of brivekimig in participants with Crohn’s disease, and the intervention listed is Sar442970.
This study is also authorised, is in Phase 2, and plans to enroll 99 participants.
The brief summary says the study is testing different doses of brivekimig on endoscopic response at the end of the induction period.
The main endpoint is the percentage of participants who achieve endoscopic response at Week 16, based on central reading.
Endoscopic response means the score on SES-CD drops by more than 50% from the start, or by at least 2 points in some participants with isolated ileal disease and a higher starting score.
Hidradenitis suppurativa study
The hidradenitis suppurativa trial is a Phase 2 study testing Sar442970 in adults with this skin disease.
This study is completed and planned to enroll 84 participants.
The brief summary says the study evaluated Sar442970 during the double-blind, placebo-controlled period in the biologic and small molecule immunosuppressive-naïve subgroup of participants with hidradenitis suppurativa.
The main endpoint is the percentage of biologic and small molecule immunosuppressive-naïve participants who achieve HiSCR50, a clinical response measure used in hidradenitis suppurativa research.
Biologic and small molecule immunosuppressive-naïve means participants had not previously used those types of immune-targeting treatments in the study subgroup description.
Main endpoints and what they mean
Each trial uses a different main endpoint, which is the main result the researchers want to measure.
- Clinical remission in ulcerative colitis means the disease signs are low enough to meet the study’s score-based definition at Week 16.
- Endoscopic response in Crohn’s disease means the inside of the bowel looks better on camera-based scoring at Week 16.
- HiSCR50 in hidradenitis suppurativa means the participant reaches a defined level of clinical improvement.
The ulcerative colitis and Crohn’s disease studies both measure results at Week 16, which is the end of the induction period described in the trial summaries.
Participants, status, and study design
These trials are designed for adults with the listed conditions.
All three studies are interventional, meaning the researchers give a study treatment or placebo and then measure outcomes.
The ulcerative colitis and Crohn’s disease studies are currently authorised, while the hidradenitis suppurativa study is completed.
The listed enrollment numbers are 165 for ulcerative colitis, 99 for Crohn’s disease, and 84 for hidradenitis suppurativa.
In the source data, the ulcerative colitis and Crohn’s disease studies use the name brivekimig in the titles and summaries, while the intervention is listed as Sar442970.