Table of Contents

• Trial overview
• Conditions studied
• Trial design and comparisons
• Who can participate
• Main outcomes being measured
• Long-term extension study in Graves’ disease

Trial overview

The trial program for IMEROPRUBART includes seven authorised studies, and all of them are in Phase 2.^{[1][2][3][4][5][6][7]} 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).^{[1][2][3][4][5][6][7]}

The listed studies use the name IMVT-1402 in the trial records, but the article focuses on the clinical trials investigating IMEROPRUBART as requested.^{[1][2][3][4][5][6][7]}

Conditions studied

The trials cover several different diseases, which means the research is not limited to one condition.^{[1][2][3][4][5][6][7]}

• 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.^[1]

• 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.^[2]

• Cutaneous lupus erythematosus is studied in one trial that focuses on skin disease activity.^[3]

• CIDP, or chronic inflammatory demyelinating polyneuropathy, is studied in one trial that looks at relapse prevention.^[4]

• Graves’ disease is studied in three trials, including two Phase 2b studies and one long-term extension study.^[5][6][7]

Trial design and comparisons

Most of the studies compare IMEROPRUBART with a placebo, which is a look-alike treatment with no active substance.^{[1][2][3][4][5][6]}

The trials are interventional, which means researchers assign the treatment to participants rather than only observing what happens.^{[1][2][3][4][5][6][7]}

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.^[5][6][7]

Who can participate

These trials are for adult participants only.^{[1][2][3][4][5][6][7]} Each study also focuses on a specific patient group, such as adults with ACPA-positive rheumatoid arthritis or adults with Graves’ disease.^[1][5][7]

Some studies include extra detail about the target group, such as adults with moderate to severe systemic disease activity in primary Sjogren’s disease.^[2] That phrase means the disease is active and affecting more than one part of the body.^[2]

Main outcomes being measured

Each trial has a primary outcome, which is the main result the study is designed to measure.^{[1][2][3][4][5][6][7]}

• 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.^[1]

• 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.^[2]

• In cutaneous lupus erythematosus, the main outcome is the percent change in CLASI-A score at Week 12, which measures skin disease activity.^[3]

• 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.^[4]

• In Graves’ disease, the main outcome is the proportion of participants who are euthyroid and off ATD at Week 26.^[5][6] Euthyroid means the thyroid hormone levels are in the normal range, and ATD means antithyroid drug, a medicine used to control an overactive thyroid.^[5][6]

The Graves’ disease studies also mention thyroid tests such as T3, FT3, FT4, and TSH, which are blood tests used to check thyroid function.^[5][6]

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.^[7] This study is in adults with Graves’ disease and measures whether Group A participants remain euthyroid, off ATD, and off IMEROPRUBART at Week 52.^[7]

This longer follow-up helps researchers see whether the treatment effect lasts over time.^[7]