In short
Clinical trials are studying IMEROPRUBART in several autoimmune diseases, including rheumatoid arthritis, Sjogren’s disease, cutaneous lupus erythematosus, CIDP, and Graves’ disease. These studies mainly look at how well it works, how safe it is, and how well people can tolerate it in adult patients.
Key points
- Clinical trials of IMEROPRUBART are being done in adults with several autoimmune diseases, including rheumatoid arthritis, Sjogren’s disease, cutaneous lupus erythematosus, CIDP, and Graves’ disease. All listed studies are Phase 2 trials, so they are mainly checking whether the treatment may work and how safe and tolerable it is. The trials compare IMEROPRUBART with placebo in several studies, while one long-term extension study follows adults with Graves’ disease over 52 weeks. The main results being measured include disease improvement scores, relapse-free status, and thyroid status in Graves’ disease. Enrollment ranges from small to larger groups, showing that the program is testing IMEROPRUBART in different patient populations.
Trial overview
The trial program for IMEROPRUBART includes seven authorised studies, and all of them are in Phase 2. These studies are testing adults with autoimmune diseases and are designed to look at efficacy (how well the treatment works), safety, and tolerability (how well people can manage the treatment).
The listed studies use the name IMVT-1402 in the trial records, but the article focuses on the clinical trials investigating IMEROPRUBART as requested.
Conditions studied
The trials cover several different diseases, which means the research is not limited to one condition.
- ACPA-positive rheumatoid arthritis is studied in one trial that looks at adults with rheumatoid arthritis who have ACPA, a specific antibody used to define this group.
- Primary Sjogren’s disease is studied in one trial focused on adults with moderate to severe systemic disease activity, meaning the disease is affecting the body more widely.
- Cutaneous lupus erythematosus is studied in one trial that focuses on skin disease activity.
- CIDP, or chronic inflammatory demyelinating polyneuropathy, is studied in one trial that looks at relapse prevention.
- Graves’ disease is studied in three trials, including two Phase 2b studies and one long-term extension study.
Trial design and comparisons
Most of the studies compare IMEROPRUBART with a placebo, which is a look-alike treatment with no active substance.
The trials are interventional, which means researchers assign the treatment to participants rather than only observing what happens.
In the Graves’ disease trials, the main comparison is between IMEROPRUBART and placebo, while the long-term extension study follows participants who receive IMEROPRUBART over time.
Who can participate
These trials are for adult participants only. Each study also focuses on a specific patient group, such as adults with ACPA-positive rheumatoid arthritis or adults with Graves’ disease.
Some studies include extra detail about the target group, such as adults with moderate to severe systemic disease activity in primary Sjogren’s disease. That phrase means the disease is active and affecting more than one part of the body.
Main outcomes being measured
Each trial has a primary outcome, which is the main result the study is designed to measure.
- In rheumatoid arthritis, the main outcome is the ACR20 response at Week 28, which means at least a 20% improvement in disease signs and symptoms.
- In primary Sjogren’s disease, the main outcome is the change in clinESSDAI score at Week 24, a score that measures disease activity in the body.
- In cutaneous lupus erythematosus, the main outcome is the percent change in CLASI-A score at Week 12, which measures skin disease activity.
- In CIDP, the main outcome is the proportion of participants who remain relapse-free by Week 24, meaning they do not have a return of disease worsening during the study period.
- In Graves’ disease, the main outcome is the proportion of participants who are euthyroid and off ATD at Week 26. Euthyroid means the thyroid hormone levels are in the normal range, and ATD means antithyroid drug, a medicine used to control an overactive thyroid.
The Graves’ disease studies also mention thyroid tests such as T3, FT3, FT4, and TSH, which are blood tests used to check thyroid function.
Long-term extension study in Graves’ disease
One study is a long-term extension study, which means it follows participants for a longer time after the main trial period. This study is in adults with Graves’ disease and measures whether Group A participants remain euthyroid, off ATD, and off IMEROPRUBART at Week 52.
This longer follow-up helps researchers see whether the treatment effect lasts over time.