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Sar442970

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.

Table of contents

Trial overview

These studies are investigating Sar442970 in adults with three different diseases: ulcerative colitis, Crohn’s disease, and hidradenitis suppurativa.[1][2][3]

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.[1][2][3]

The studies compare Sar442970 with a placebo, which is a look-alike treatment with no active study drug.[1][2][3]

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.[1]

This study is authorised, is in Phase 2, and plans to enroll 165 participants.[1]

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.[1]

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.[1]

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.[1]

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.[2]

This study is also authorised, is in Phase 2, and plans to enroll 99 participants.[2]

The brief summary says the study is testing different doses of brivekimig on endoscopic response at the end of the induction period.[2]

The main endpoint is the percentage of participants who achieve endoscopic response at Week 16, based on central reading.[2]

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.[2]

Hidradenitis suppurativa study

The hidradenitis suppurativa trial is a Phase 2 study testing Sar442970 in adults with this skin disease.[3]

This study is completed and planned to enroll 84 participants.[3]

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.[3]

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.[3]

Biologic and small molecule immunosuppressive-naïve means participants had not previously used those types of immune-targeting treatments in the study subgroup description.[3]

Main endpoints and what they mean

Each trial uses a different main endpoint, which is the main result the researchers want to measure.[1][2][3]

  • Clinical remission in ulcerative colitis means the disease signs are low enough to meet the study’s score-based definition at Week 16.[1]
  • Endoscopic response in Crohn’s disease means the inside of the bowel looks better on camera-based scoring at Week 16.[2]
  • HiSCR50 in hidradenitis suppurativa means the participant reaches a defined level of clinical improvement.[3]

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.[1][2]

Participants, status, and study design

These trials are designed for adults with the listed conditions.[1][2][3]

All three studies are interventional, meaning the researchers give a study treatment or placebo and then measure outcomes.[1][2][3]

The ulcerative colitis and Crohn’s disease studies are currently authorised, while the hidradenitis suppurativa study is completed.[1][2][3]

The listed enrollment numbers are 165 for ulcerative colitis, 99 for Crohn’s disease, and 84 for hidradenitis suppurativa.[1][2][3]

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.[1][2]

Trial ID Phase Condition studied Status Enrollment
2024-515241-41-00 Phase 2 Ulcerative Colitis Authorised 165
NCT06958536 Phase 2 Crohn’s disease Authorised 99
NCT05849922 Phase 2 Hidradenitis suppurativa Completed 84

FAQ

  • What is being studied in Sar442970 trials? The trials are studying whether Sar442970 can help adults with ulcerative colitis, Crohn’s disease, or hidradenitis suppurativa. The main focus is on how well it works and how safe it is.
  • Who can take part in these studies? The studies are in adults. Some trials focus on people with moderate to severe ulcerative colitis, while others include people with Crohn’s disease or hidradenitis suppurativa.
  • What phase are the Sar442970 trials? The trials listed are Phase 2 studies. Phase 2 means the treatment is being tested in a larger group to see if it works and to learn more about safety.
  • What results are the trials measuring? The ulcerative colitis study measures clinical remission at Week 16. The Crohn’s disease study measures endoscopic response at Week 16, and the hidradenitis suppurativa study measures HiSCR50, which is a clinical response score.
  • Are all the Sar442970 studies finished? No. One study in hidradenitis suppurativa is completed, while the ulcerative colitis and Crohn’s disease studies are authorised.

Ongoing Clinical Trials on Sar442970

  • Study of SAR442970 to treat moderate to severe ulcerative colitis in adults

    Recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Hungary Poland Spain

  • Testing SAR442970 compared to placebo in adults with moderate to severe Crohn’s disease

    Recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Germany Poland Spain

  • Study on the Effects and Safety of SAR442970 for Adults with Moderate to Severe Hidradenitis Suppurativa

    Not recruiting

    1
    Investigated drugs:
    Belgium Czechia Denmark France Germany Greece +5

Glossary

  • Phase 2: A study stage where a treatment is tested in a larger group of people to see whether it may help and to learn more about safety.
  • Interventional study: A study where participants receive a treatment or placebo so researchers can compare results.
  • Placebo: A look-alike treatment with no active study drug. It helps researchers compare results fairly.
  • Ulcerative colitis: A long-term disease that causes inflammation and sores in the large intestine.
  • Crohn’s disease: A long-term disease that causes inflammation in the digestive tract.
  • Hidradenitis suppurativa: A long-term skin disease that can cause painful lumps, abscesses, and scarring.
  • Clinical remission: A state where signs and symptoms are very low or absent, based on the study’s scoring rules.
  • Endoscopic response: An improvement seen during endoscopy, which is a test using a camera to look inside the body.
  • Endoscopy: A procedure that uses a thin tube with a camera to view the inside of the digestive tract.
  • HiSCR50: A study measure for hidradenitis suppurativa showing a meaningful clinical improvement.
  • Enrollment: The number of participants planned or included in a study.
  • Central reading: A review of test results by a central expert reader to keep the study assessment consistent.

References