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

ImmunAbs Inc.

Status and phase: Begins enrollment this month; Phase 2; Phase 1

Conditions: Myasthenia Gravis

Treatments: Drug: IM-101 Part A; Drug: IM-101 Part B; Drug: Placebo Part A; Drug: Placebo Part B

Study type: Interventional

Funder types: Industry

Identifiers

NCT07250750

2025-522406-20-00 (EU Trial (CTIS) Number)

IM-101_MG_2.1

Details and patient eligibility

About

The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential efficacy of IM-101 in adult participants with AChR antibody-positive gMG. Subsequently, the safety and efficacy of the selected IM-101 dose-regimen will be tested in participants with AChR antibody-negative gMG and participants with AChR antibody-positive or AChR antibody-negative oMG.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Able and willing to provide signed informed consent
2. Willingness to consent to screening for genetic muscular diseases
3. Male or female aged ≥ 18 years and < 75 years
4. Diagnosed with MG
5. On a stable dose of background therapy for the treatment of MG
6. Body weight ≥ 40 kg at screening
7. Vaccinated against meningococcal infection (Neisseria meningitidis), streptococcus pneumoniae, and haemophilus influenzae type B

Exclusion criteria

1. Previous exposure to IM-101
2. Anti-MuSK antibody Positive
3. History of malignant thymoma, or history of cancer within the past 5 years of screening
4. History of N. meningitidis infection
5. Has been treated with any complement inhibitor, but failed due to intolerability or lack of efficacy

Full eligibility criteria is available in the study protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 7 patient groups

Part A MAD Cohort 1

Experimental group

Description:

IM-101 Low dose or Placebo

Treatment:

Drug: Placebo Part A

Drug: IM-101 Part A

Part A MAD Cohort 2

Experimental group

Description:

IM-101 Mid dose or Placebo

Treatment:

Drug: Placebo Part A

Drug: IM-101 Part A

Part A MAD Cohort 3

Experimental group

Description:

IM-101 High dose or Placebo

Treatment:

Drug: Placebo Part A

Drug: IM-101 Part A

Part A MAD Cohort 4 (Optional)

Experimental group

Description:

IM-101 or Placebo if additional dose is needed per IDMC decision

Treatment:

Drug: Placebo Part A

Drug: IM-101 Part A

Part B Expansion AChR positive gMG

Experimental group

Description:

IM-101 or Placebo

Treatment:

Drug: Placebo Part B

Drug: IM-101 Part B

Part B Expansion AChR negative gMG

Experimental group

Description:

IM-101 or Placebo

Treatment:

Drug: Placebo Part B

Drug: IM-101 Part B

Part B Expansion oMG

Experimental group

Description:

IM-101 or Placebo

Treatment:

Drug: Placebo Part B

Drug: IM-101 Part B