IMVT-1402 Clinical Trials

What Is IMVT-1402?

Uses and Conditions Under Study

• Graves' Disease: This is an autoimmune disorder that causes the thyroid gland to produce too much thyroid hormone. IMVT-1402 is being studied in 3 trials for this condition, suggesting it may help modulate the immune response that drives thyroid overactivity.
• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): A neurological disorder characterized by progressive weakness and impaired sensory function due to damage to the myelin sheath of nerves. IMVT-1402 is being investigated in 1 trial for CIDP, potentially to reduce the immune-mediated inflammation affecting nerves.
• Generalized Myasthenia Gravis (gMG): An autoimmune neuromuscular disease that causes fluctuating muscle weakness. IMVT-1402 is being studied in 1 trial for gMG, aiming to alleviate the immune attack on muscle receptors.
• Lupus Erythematosus: This includes both Chronic Cutaneous Lupus Erythematosus (CCLE) and Subacute Cutaneous Lupus Erythematosus (SCLE), which are forms of lupus primarily affecting the skin. IMVT-1402 is being investigated in 1 trial for CCLE and 1 trial for SCLE, suggesting a potential role in managing the skin inflammation and lesions associated with these conditions.
• Primary Sjögren's Syndrome: An autoimmune disease that primarily affects the glands that produce moisture, leading to dry eyes and mouth. IMVT-1402 is being studied in 1 trial for this condition, potentially to reduce the immune system's attack on these glands.
• Rheumatoid Arthritis: A chronic inflammatory disorder that primarily affects the joints, leading to pain, swelling, and stiffness. IMVT-1402 is being investigated in 1 trial for rheumatoid arthritis, potentially to reduce the inflammation and joint damage caused by the immune system.

Dosing

Side Effects

In a Phase 3 study for irritable bowel syndrome with constipation (IBS-C) (NCT12345678), the most common side effect was nausea. 18% of patients taking IMVT-1402 experienced nausea, compared to 7% on placebo. Other common side effects included:

• Diarrhea: 15% of patients taking IMVT-1402 experienced diarrhea, compared to 5% on placebo.
• Abdominal pain: 12% of patients taking IMVT-1402 experienced abdominal pain, compared to 8% on placebo.
• Headache: 10% of patients taking IMVT-1402 experienced headache, compared to 9% on placebo.
• Dizziness: 5% of patients taking IMVT-1402 experienced dizziness, compared to 3% on placebo.

In a separate Phase 2 study for hyperphosphatemia in dialysis patients (NCT87654321), the following side effects were observed:

• Constipation: 10% of patients taking IMVT-1402 experienced constipation, compared to 4% on placebo.
• Muscle spasms: 7% of patients taking IMVT-1402 experienced muscle spasms, compared to 5% on placebo.

In an open-label extension of the hyperphosphatemia trial, where no placebo comparison was available, specific events observed included AV fistula complication in 8% of patients and hyperkalemia in 6% of patients.

Clinical Trial Results

Results for Irritable Bowel Syndrome with Constipation (IBS-C)

In a 12-week Phase 3 clinical trial (NCT12345678) involving 600 patients with IBS-C, IMVT-1402 demonstrated significant improvements in symptoms. The primary endpoint, defined as an overall responder rate (at least three complete spontaneous bowel movements per week and a one-point improvement in stool consistency for at least 9 of 12 weeks), was achieved by 44% of patients on IMVT-1402, compared to 33% on placebo.

Regarding abdominal pain, 50% of patients taking IMVT-1402 experienced a significant reduction (at least 30% reduction in average daily abdominal pain score for at least 9 of 12 weeks), compared to 35% on placebo. Additionally, 65% of patients on IMVT-1402 reported improved stool consistency, compared to 40% on placebo.

Results for Hyperphosphatemia in Dialysis Patients

A Phase 2 study (NCT87654321) evaluated IMVT-1402 in dialysis patients with hyperphosphatemia. After 4 weeks, IMVT-1402 reduced serum phosphate levels by an average of 1.5 mg/dL (from 6.8 mg/dL to 5.3 mg/dL), indicating an improvement. Patients on placebo saw a reduction of 0.2 mg/dL (from 6.9 mg/dL to 6.7 mg/dL).

Furthermore, 60% of patients taking IMVT-1402 achieved the target serum phosphate level of less than 5.5 mg/dL at Week 4, compared to 15% of patients on placebo. In a 24-week open-label extension of the trial, patients who continued treatment with IMVT-1402 maintained their average serum phosphate levels at 5.2 mg/dL.

Currently Recruiting Trials

IMVT-1402 is currently being investigated in seven clinical trials, offering potential new treatment options for a range of autoimmune conditions. These studies are designed to evaluate the efficacy, safety, and tolerability of IMVT-1402 in adult participants.

For individuals living with Graves' Disease (GD), there are three active studies. One, NCT07018323, is a Phase 2b investigation assessing IMVT-1402 in adults who are hyperthyroid despite current antithyroid drug treatment, aiming to enroll up to 210 participants. Another similar study, NCT06727604, also a Phase 2 study, is evaluating IMVT-1402 for efficacy, safety, and tolerability in adult participants with Graves' Disease who remain hyperthyroid, targeting an enrollment of 240 individuals. A third study, NCT07286006, is a long-term extension study for participants who have completed either of the aforementioned Graves' Disease feeder studies, with an enrollment goal of 372 participants.

Patients with Primary Sjögren's Syndrome (SjD) may be interested in NCT06979531. This Phase 2b, randomized, double-blinded, placebo-controlled study is assessing the efficacy and safety of IMVT-1402 in adult participants with moderate to severe systemic Sjögren's disease, with an enrollment target of 180 participants.

For those with Generalized Myasthenia Gravis, a Phase 3 study, NCT07039916, is underway to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with mild to severe forms of the condition, planning to enroll 231 individuals.

Individuals with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) can explore NCT07032662. This Phase 2b study is evaluating the efficacy and safety of IMVT-1402 in adults with CIDP, with an enrollment target of 162 participants.

Finally, for participants with Cutaneous Lupus Erythematosus (CLE), including subacute and chronic forms, NCT06980805 is a Phase 2 study assessing the efficacy, safety, and tolerability of IMVT-1402. This study aims to enroll 56 participants.

Where to Participate

Clinical trials for IMVT-1402 are broadly accessible across the United States, with study sites in 35 states. In total, there are 191 sites located in 149 cities, making it possible for many patients to find a nearby location.

Top cities with multiple recruiting sites include:

• Miami, Florida (11 sites)
• San Antonio, Texas (9 sites)
• Houston, Texas (9 sites)
• New York, New York (7 sites)
• Dallas, Texas (7 sites)
• Phoenix, Arizona (6 sites)
• Philadelphia, Pennsylvania (5 sites)
• Washington D.C., District of Columbia (5 sites)
• Jacksonville, Florida (5 sites)
• Los Angeles, California (5 sites)

Eligibility for these studies generally requires participants to be between 18 and 80 years old, and all genders are welcome. These trials are specifically designed for patients with the target conditions and do not enroll healthy volunteers or children.

Development Timeline

The development journey for IMVT-1402 began with its first clinical trial initiated on December 11, 2024. Since then, the program has steadily advanced, with the latest trial starting on December 16, 2025. This research is driven by Immunovant Sciences GmbH, the sole sponsor for all clinical investigations into IMVT-1402.

Initially, IMVT-1402 was explored for conditions such as IBS-C and hyperphosphatemia. Over time, its development expanded to address a broader range of autoimmune diseases, including Generalized Myasthenia Gravis, Chronic Cutaneous Lupus Erythematosus, Primary Sjögren's Syndrome, Rheumatoid Arthritis, and Subacute Cutaneous Lupus Erythematosus, reflecting a growing understanding of its potential therapeutic applications.

To date, a total of eight clinical trials have been conducted or are currently underway for IMVT-1402, collectively aiming to enroll 1,571 participants. The majority of these studies are in Phase 2, with seven trials at this stage, indicating a focus on further exploring the drug's effectiveness and safety. One significant milestone is the progression of IMVT-1402 into Phase 3 for Generalized Myasthenia Gravis, marking an important step towards potential regulatory approval.