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

NCT07250750 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: IM-101_MG_2.12025-522406-20-00
• Study Type: interventional
• Target: 96
• Locations: 6 countries
• Sites: 25

Brief Summary

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.

Conditions

Myasthenia Gravis

Keywords

IM-101; Myasthenia Gravis; C5 inhibitor

Outcome Measures

Primary Outcomes (4)

• [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.

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

• [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.

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

• [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.

  Baseline, Week 16

• [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.

  Baseline, Week 16

Study Arms (7)

Part A MAD Cohort 1

EXPERIMENTAL

IM-101 Low dose or Placebo

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

Part A MAD Cohort 2

EXPERIMENTAL

IM-101 Mid dose or Placebo

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

Part A MAD Cohort 3

EXPERIMENTAL

IM-101 High dose or Placebo

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

Part A MAD Cohort 4 (Optional)

EXPERIMENTAL

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

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

Part B Expansion AChR positive gMG

EXPERIMENTAL

IM-101 or Placebo

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

Part B Expansion AChR negative gMG

EXPERIMENTAL

IM-101 or Placebo

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

Part B Expansion oMG

EXPERIMENTAL

IM-101 or Placebo

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

Interventions

IM-101 Part A DRUG

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

Part A MAD Cohort 1; Part A MAD Cohort 2; Part A MAD Cohort 3; Part A MAD Cohort 4 (Optional)

Placebo Part A DRUG

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

Part A MAD Cohort 1; Part A MAD Cohort 2; Part A MAD Cohort 3; Part A MAD Cohort 4 (Optional)

IM-101 Part B DRUG

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.

Part B Expansion AChR negative gMG; Part B Expansion AChR positive gMG; Part B Expansion oMG

Placebo Part B DRUG

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.

Part B Expansion AChR negative gMG; Part B Expansion AChR positive gMG; Part B Expansion oMG

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous exposure to IM-101
• Anti-MuSK antibody Positive
• History of malignant thymoma, or history of cancer within the past 5 years of screening
• History of N. meningitidis infection
• 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.

Sponsors & Collaborators

• ImmunAbs Inc.: lead

Study Sites (25)

Neurology of Central Florida Research Center, LLC

Altamonte Springs, Florida, 32714, United States

RECRUITING

SFM Clinical Research, LLC

Boca Raton, Florida, 33487, United States

RECRUITING

Aqualane Clinical Research

Naples, Florida, 34105, United States

RECRUITING

Medsol Clinical Research Center

Port Charlotte, Florida, 33952, United States

NOT YET RECRUITING

University of South Florida

Tampa, Florida, 33612, United States

NOT YET RECRUITING

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Missouri, 66103, United States

NOT YET RECRUITING

Nerve & Muscle Center of Texas

Houston, Texas, 77030, United States

RECRUITING

Houston Methodist Neurological Institute

Houston, Texas, 77070, United States

NOT YET RECRUITING

Medical Center Hera - branch Montana

Montana, 3400, Bulgaria

NOT YET RECRUITING

"MHAT Avis - Medica" OOD

Pleven, 5800, Bulgaria

NOT YET RECRUITING

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, 5800, Bulgaria

NOT YET RECRUITING

UMHAT 'Tsaritsa Yoanna - ISUL', EAD

Sofia, 1527, Bulgaria

NOT YET RECRUITING

Haelan Care 4 Medical Center EOOD

Varna, 9009, Bulgaria

NOT YET RECRUITING

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

Brescia, Brescia, 25123, Italy

NOT YET RECRUITING

Ospedale San Raffaele

Milan, Milano, 20132, Italy

NOT YET RECRUITING

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Milano, 20133, Italy

NOT YET RECRUITING

Neurologia Slaska Centrum Medyczne

Katowice, 40-689, Poland

NOT YET RECRUITING

Twoja Przychodnia NCM

Nowa Sól, 67-100, Poland

NOT YET RECRUITING

Twoja Przychodnia PCM

Poznan, 60-324, Poland

NOT YET RECRUITING

NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy

Poznan, 61-853, Poland

NOT YET RECRUITING

Samodzielny Publiczny Szpital Kliniczny nr 1 im. Prof. Stanislawa Szyszko, SUM

Zabrze, 41-800, Poland

NOT YET RECRUITING

General Hospital MSB Medical System Belgrade

Belgrade, 11000, Serbia

NOT YET RECRUITING

Hospital Universitario Clinico San Carlos

Madrid, Madrid, 28040, Spain

NOT YET RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

NOT YET RECRUITING

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

ImmunAbs Clinical Team

CONTACT

82-2-6951-0584; info@immunabs.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2025
• First Posted: November 26, 2025
• Study Start: February 5, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

ES (3); US (8); PL (5); BU (5); SE (1); IT (3)