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

February 9, 2026 updated by: ImmunAbs Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bulgaria
      • Montana, Bulgaria, 3400
        • Not yet recruiting
        • Medical Center Hera - branch Montana
        • Contact:
      • Pleven, Bulgaria, 5800
        • Not yet recruiting
        • UMHAT 'Dr. Georgi Stranski', EAD
        • Contact:
      • Pleven, Bulgaria, 5800
        • Not yet recruiting
        • "MHAT Avis - Medica" OOD
        • Contact:
      • Sofia, Bulgaria, 1527
        • Not yet recruiting
        • UMHAT 'Tsaritsa Yoanna - ISUL', EAD
        • Contact:
      • Varna, Bulgaria, 9009
  • Italy
    • Brescia
      • Brescia, Brescia, Italy, 25123
        • Not yet recruiting
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
        • Contact:
    • Milano
      • Milan, Milano, Italy, 20133
      • Milan, Milano, Italy, 20132
  • Poland
      • Katowice, Poland, 40-689
      • Nowa Sól, Poland, 67-100
        • Not yet recruiting
        • Twoja Przychodnia NCM
        • Contact:
      • Poznan, Poland, 60-324
      • Poznan, Poland, 61-853
        • Not yet recruiting
        • NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy
        • Contact:
      • Zabrze, Poland, 41-800
        • Not yet recruiting
        • Samodzielny Publiczny Szpital Kliniczny nr 1 im. Prof. Stanislawa Szyszko, SUM
        • Contact:
  • Serbia
      • Belgrade, Serbia, 11000
        • Not yet recruiting
        • General Hospital MSB Medical System Belgrade
        • Contact:
  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28046
      • Madrid, Madrid, Spain, 28040
        • Not yet recruiting
        • Hospital Universitario Clínico San Carlos
        • Contact:
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Not yet recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Beatriz Urbeltz
          • Phone Number: +34948255400
          • Email: eecc@unav.es
  • United States
    • Florida
      • Altamonte Springs, Florida, United States, 32714
        • Recruiting
        • Neurology of Central Florida Research Center, LLC
        • Contact:
      • Boca Raton, Florida, United States, 33487
      • Naples, Florida, United States, 34105
      • Port Charlotte, Florida, United States, 33952
        • Not yet recruiting
        • Medsol Clinical Research Center
        • Contact:
      • Tampa, Florida, United States, 33612
        • Not yet recruiting
        • University of South Florida
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 66103
        • Not yet recruiting
        • University of Kansas Medical Center Research Institute, Inc.
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Nerve & Muscle Center of Texas
        • Contact:
      • Houston, Texas, United States, 77070
        • Not yet recruiting
        • Houston Methodist Neurological Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
[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
Time Frame: From first dose of study drug (Day 1) up to 70 days after the last dose of study drug, up to approximately 99 days.
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
Time Frame: From first dose of study drug (Day 1) up to 84 days after the last dose of study drug, up to approximately 169 days.
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
Time Frame: Baseline, Week 16
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
Time Frame: Baseline, Week 16
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImmunAbs Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

October 26, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM-101_MG_2.1
  • 2025-522406-20-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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