Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 74Years
All Genders
NCT07250750

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

Led by ImmunAbs Inc. · Updated on 2026-02-11

96

Participants Needed

25

Research Sites

121 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 74Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able and willing to provide signed informed consent
  • Willing to consent to screening for genetic muscular diseases
  • Male or female aged 6 18 years and < 75 years
  • Diagnosed with myasthenia gravis
  • On a stable dose of background therapy for myasthenia gravis
  • Body weight 6 40 kg at screening
  • Vaccinated against meningococcal infection, streptococcus pneumoniae, and haemophilus influenzae type B
Not Eligible

You will not qualify if you...

  • Previous exposure to IM-101
  • Positive for anti-MuSK antibody
  • History of malignant thymoma or cancer within the past 5 years
  • History of Neisseria meningitidis infection
  • Treated with any complement inhibitor and failed due to intolerability or lack of efficacy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 25 locations

1

Neurology of Central Florida Research Center, LLC

Altamonte Springs, Florida, United States, 32714

Actively Recruiting

2

SFM Clinical Research, LLC

Boca Raton, Florida, United States, 33487

Actively Recruiting

3

Aqualane Clinical Research

Naples, Florida, United States, 34105

Actively Recruiting

4

Medsol Clinical Research Center

Port Charlotte, Florida, United States, 33952

Not Yet Recruiting

5

University of South Florida

Tampa, Florida, United States, 33612

Not Yet Recruiting

6

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Missouri, United States, 66103

Not Yet Recruiting

7

Nerve & Muscle Center of Texas

Houston, Texas, United States, 77030

Actively Recruiting

8

Houston Methodist Neurological Institute

Houston, Texas, United States, 77070

Not Yet Recruiting

9

Medical Center Hera - branch Montana

Montana, Bulgaria, 3400

Not Yet Recruiting

10

"MHAT Avis - Medica" OOD

Pleven, Bulgaria, 5800

Not Yet Recruiting

11

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, Bulgaria, 5800

Not Yet Recruiting

12

UMHAT 'Tsaritsa Yoanna - ISUL', EAD

Sofia, Bulgaria, 1527

Not Yet Recruiting

13

Haelan Care 4 Medical Center EOOD

Varna, Bulgaria, 9009

Not Yet Recruiting

14

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

Brescia, Brescia, Italy, 25123

Not Yet Recruiting

15

Ospedale San Raffaele

Milan, Milano, Italy, 20132

Not Yet Recruiting

16

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Milano, Italy, 20133

Not Yet Recruiting

17

Neurologia Slaska Centrum Medyczne

Katowice, Poland, 40-689

Not Yet Recruiting

18

Twoja Przychodnia NCM

Nowa Sól, Poland, 67-100

Not Yet Recruiting

19

Twoja Przychodnia PCM

Poznan, Poland, 60-324

Not Yet Recruiting

20

NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy

Poznan, Poland, 61-853

Not Yet Recruiting

21

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

Zabrze, Poland, 41-800

Not Yet Recruiting

22

General Hospital MSB Medical System Belgrade

Belgrade, Serbia, 11000

Not Yet Recruiting

23

Hospital Universitario Clinico San Carlos

Madrid, Madrid, Spain, 28040

Not Yet Recruiting

24

Hospital Universitario La Paz

Madrid, Madrid, Spain, 28046

Not Yet Recruiting

25

Clinica Universidad de Navarra

Pamplona, Navarre, Spain, 31008

Not Yet Recruiting

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Research Team

I

ImmunAbs Clinical Team

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

7

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