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

Purpose

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.

Condition

Myasthenia Gravis

Eligibility

Eligible Ages: Between 18 Years and 74 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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.

Study Design

Phase: Phase 1/Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Part A MAD Cohort 1	IM-101 Low dose or Placebo	Drug: IM-101 Part A Participants will receive IM-101 intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose and Day 29. Drug: Placebo Part A Participants will receive Placebo intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose on Day 29.
Experimental Part A MAD Cohort 2	IM-101 Mid dose or Placebo	Drug: IM-101 Part A Participants will receive IM-101 intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose and Day 29. Drug: Placebo Part A Participants will receive Placebo intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose on Day 29.
Experimental Part A MAD Cohort 3	IM-101 High dose or Placebo	Drug: IM-101 Part A Participants will receive IM-101 intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose and Day 29. Drug: Placebo Part A Participants will receive Placebo intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose on Day 29.
Experimental Part A MAD Cohort 4 (Optional)	IM-101 or Placebo if additional dose is needed per IDMC decision	Drug: IM-101 Part A Participants will receive IM-101 intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose and Day 29. Drug: Placebo Part A Participants will receive Placebo intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose on Day 29.
Experimental Part B Expansion AChR positive gMG	IM-101 or Placebo	Drug: IM-101 Part B 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. Drug: Placebo Part B 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.
Experimental Part B Expansion AChR negative gMG	IM-101 or Placebo	Drug: IM-101 Part B 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. Drug: Placebo Part B 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.
Experimental Part B Expansion oMG	IM-101 or Placebo	Drug: IM-101 Part B 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. Drug: Placebo Part B 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.

Recruiting Locations

Neurology of Central Florida Research Center, LLC
Altamonte Springs, Florida 32714

Contact:
Adiana Perez
4077904904
adiresearchcfl@gmail.com

SFM Clinical Research, LLC
Boca Raton, Florida 33487

Contact:
Gabrielle DeMaria
5619390333
gabrielle@sfmresearch.com

Aqualane Clinical Research
Naples, Florida 34105

Contact:
Matthew Cagney
2395296780
matthewc@aqualaneresearch.com

Nerve & Muscle Center of Texas
Houston, Texas 77030

Contact:
Amy Megerle
7137950033
houneuamy@msn.com

More Details

NCT ID: NCT07250750
Status: Recruiting
Sponsor: ImmunAbs Inc.

Study Contact

ImmunAbs Clinical Team
82-2-6951-0584
info@immunabs.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.