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Rosnilimab

Clinical trials are studying Rosnilimab in people with moderate to severe rheumatoid arthritis and ulcerative colitis. These studies aim to see whether Rosnilimab is safe and effective compared with placebo. Both trials are phase 2 and have already been completed.

Table of Contents

Trial overview

Two clinical trials have studied Rosnilimab, and both were Phase 2 studies.[1][2] Both trials were interventional, which means researchers gave a study treatment and measured the results.[1][2] Both studies are listed as completed.[1][2]

Rheumatoid arthritis study

One study tested Rosnilimab in people with moderate to severe rheumatoid arthritis, a disease that causes joint inflammation and pain.[1] This trial enrolled 420 participants.[1] The study title says it was randomized, double blind, and placebo controlled, which are trial methods used to make the comparison fair and reduce bias.[1]

The main efficacy endpoint, or main result the study wanted to measure, was the mean change from baseline in DAS28-CRP at week 12.[1] DAS28-CRP is a score used to track rheumatoid arthritis disease activity, and baseline means the starting point before treatment began.[1]

Ulcerative colitis study

The second study looked at Rosnilimab in people with ulcerative colitis, a long-term inflammatory disease of the large intestine.[2] This trial enrolled 132 participants.[2] Like the rheumatoid arthritis study, it was a phase 2 interventional trial and was completed.[2]

This study also compared Rosnilimab with placebo, meaning a look-alike treatment without the active study drug.[2] Its primary efficacy endpoint was the mean change from baseline in mMS at week 12.[2] The source data does not define mMS, but it is the main measure the study used to judge whether treatment helped.[2]

Study design and comparators

Both Rosnilimab trials used a placebo-controlled design, which helps researchers see whether changes are due to the study treatment rather than chance or expectations.[1][2] The rheumatoid arthritis trial was also described as double blind, meaning participants and study staff did not know which treatment each person received during the study.[1]

The interventions listed in the source data include Rosnilimab given by subcutaneous use, which means under the skin, and matching placebo or matching solution for injection.[1][2] This kind of matching treatment helps keep the study fair because the comparison groups look similar.[1][2]

Outcomes measured

The main outcome in the rheumatoid arthritis trial was change in DAS28-CRP from baseline to week 12.[1] This tells researchers whether disease activity improved over time.[1]

The main outcome in the ulcerative colitis trial was change in mMS from baseline to week 12.[2] This means the study focused on whether the disease score changed after 12 weeks of treatment.[2]

What these trials mean for patients

These studies show that Rosnilimab was tested in two different inflammatory diseases, both with moderate to severe illness.[1][2] The trials were designed to look for early signs of benefit and to continue safety checking in phase 2.[1][2] Because both studies are completed, the trial records reflect research that has already been carried out rather than ongoing enrollment.[1][2]

Trial ID Phase Condition studied Status Enrollment
2023-504564-42-00 Phase 2 Moderate to severe rheumatoid arthritis Completed 420
2023-508679-34-00 Phase 2 Ulcerative colitis Completed 132

FAQ

  • What conditions has Rosnilimab been studied in? Rosnilimab has been studied in moderate to severe rheumatoid arthritis and ulcerative colitis. Both trials looked at people with active disease.
  • What phase are the Rosnilimab trials? The available trials are phase 2 studies. Phase 2 trials usually look at early signs of benefit and continue to check safety.
  • Were the Rosnilimab studies placebo controlled? Yes. Both trials compared Rosnilimab with placebo, which is a look-alike treatment with no active study drug. This helps show whether the study drug works better than no active treatment.
  • Who could join these trials? The trials enrolled adults with moderate to severe disease. One study was for rheumatoid arthritis and the other was for ulcerative colitis.
  • What were the main results measured in these trials? The rheumatoid arthritis study measured change in DAS28-CRP at week 12. The ulcerative colitis study measured change in mMS at week 12.

Ongoing Clinical Trials on Rosnilimab

  • Study on Rosnilimab for Patients with Moderate to Severe Rheumatoid Arthritis

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Belgium Estonia France Germany Hungary Italy +3

  • Study on the Effectiveness and Safety of Rosnilimab for Patients with Moderate to Severe Ulcerative Colitis

    Not recruiting

    2 1
    Investigated drugs:
    Austria Bulgaria Croatia France Germany Italy +4

Glossary

  • Phase 2: A mid-stage clinical trial that checks whether a treatment may help and continues to monitor safety.
  • Randomized: Participants are assigned by chance to different study groups, which helps make the comparison fair.
  • Double blind: Neither the participants nor the study team know who is getting the study drug or placebo during the trial.
  • Placebo: A look-alike treatment that does not contain the active study drug. It is used for comparison.
  • Interventional study: A study where researchers give a treatment and then measure the results.
  • Moderate to severe rheumatoid arthritis: A form of rheumatoid arthritis with stronger symptoms and more disease activity.
  • Ulcerative colitis: A long-term disease that causes inflammation and sores in the large intestine.
  • DAS28-CRP: A score used to measure rheumatoid arthritis activity. It combines joint findings with a blood marker called CRP.
  • mMS: A measure used in ulcerative colitis trials to assess disease activity and response.
  • Baseline: The starting point before treatment begins, used for comparison later in the study.
  • Week 12: The study visit or time point 12 weeks after treatment starts.

References

  1. https://clinicaltrials.gov/study/NCT06127043
  2. https://clinicaltrials.gov/study/NCT06041269