A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 74 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

25 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

About this study

Official title: A Phase 1b/2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate A) the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of IM-101 in Adult Participants With Generalized Myasthenia Gravis, and B) the Efficacy and Safety of Treatment of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis

Conditions

Myasthenia Gravis

Being tested

IM-101 Part A, Placebo Part A, IM-101 Part B, Placebo Part B

Keywords

IM-101, Myasthenia Gravis, C5 inhibitor

Medical subject headings

Myasthenia Gravis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• IM-101 Part ADrug

  Participants will receive IM-101 intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose and Day 29.

• Placebo Part ADrug

  Participants will receive Placebo intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose on Day 29.

• IM-101 Part BDrug

  Participants will receive IM-101 intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose on Day 29, D57 and D85.

• Placebo Part BDrug

  Participants will receive Placebo intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose on Day 29, D57 and D85.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. [Part A] Incidence of TEAEs, SAEs, AEs that led to premature discontinuation, and AESIs across 3 ascending dose regimens (each with 3 administrations) in participants with AChR antibody-positive gMG

   An AE is any untoward medical occurrence in a clinical study participant administered with a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important. Treatment-emergent AEs associated with a. Grade > 2 hypersensitivity or IRR, b. Infection c. Any potential kidney failure and d. Any potential Hy's Law case (> 3 × ULN of either ALT/AST with concurrent > 2 × ULN of total bilirubin and lack of alternate etiology) will be considered AESIs.

   Measured: From first dose of study drug (Day 1) up to 70 days after the last dose of study drug, up to approximately 99 days.

2. [Part B] Incidence of TEAEs, SAEs, AEs that led to premature discontinuation, and AESIs of IM-101, compared with placebo, in participants with AChR antibody-positive gMG, AChR antibody-negative gMG, and oMG

   An AE is any untoward medical occurrence in a clinical study participant administered with a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important. Treatment-emergent AEs associated with a. Grade > 2 hypersensitivity or IRR, b. Infection c. Any potential kidney failure and d. Any potential Hy's Law case (> 3 × ULN of either ALT/AST with concurrent > 2 × ULN of total bilirubin and lack of alternate etiology) will be considered AESIs.

   Measured: From first dose of study drug (Day 1) up to 84 days after the last dose of study drug, up to approximately 169 days.

3. [Part B] Change from baseline to Week 16 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score for gMG cohorts

   Change from baseline in MG-ADL total score over 16 Weeks will be reported. The MG-ADL provides a rapid assessment of the participant's MG symptom severity. Eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, eyelid droop) are rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score will be sum of eight function scores and can range from 0 to 24. A higher score indicates greater symptom severity.

   Measured: Baseline, Week 16

4. [Part B]Change from baseline to Week 16 in Myasthenia Gravis Impairment Index (MGII) ocular score for oMG cohorts

   Change from baseline in MGII ocular score over 16 Weeks will be reported. The MGII is a scoring tool measuring disease severity. It consists of 22 patient-reported outcomes (PRO) and 6 physical examinations (PE). The Ocular PRO score varies between 0 and 18. The higher the score, the more severe the disease.

   Measured: Baseline, Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted26 Nov 2025
2. Study start5 Feb 2026
3. Primary completionDec 2027 (estimated)
4. Study completionJun 2028 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Myasthenia GravisStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.