Actively Recruiting
A Phase 1b/2 Study of IM-101 to Evaluate Safety, Tolerability, and Efficacy in Adults With Generalized and Ocular Myasthenia Gravis
Led by ImmunAbs Inc. · Updated on 2026-02-11
96
Participants Needed
25
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating IM-101 in adults with generalized myasthenia gravis (gMG) and ocular myasthenia gravis (oMG), focusing on those with acetylcholine receptor (AChR) antibody-positive and AChR antibody-negative forms. The goal is to assess the safety, tolerability, how the drug moves through and affects the body, and the potential effectiveness of IM-101. This Phase 1b/2 trial is sponsored by ImmunAbs Inc. and includes multiple study parts to explore these aspects thoroughly. Participants will receive IM-101 or a placebo through intravenous infusions. In Part A, participants get a loading dose on Day 1 and Day 15, followed by a maintenance dose on Day 29, with doses escalating across cohorts. In Part B, dosing includes loading doses on Day 1 and Day 15 and maintenance doses on Days 29, 57, and 85. Some may receive additional doses depending on decisions by an independent data monitoring committee. The study uses randomized, double-blind assignments to compare different dose levels and placebo effects. During the study, participants will be monitored for side effects and safety up to about 99 days in Part A and 169 days in Part B. Researchers will assess the impact of treatment on daily living activities and specific myasthenia gravis severity scores at baseline and Week 16. Safety assessments include tracking adverse events, serious adverse events, and events leading to discontinuation. Participants will undergo regular evaluations to measure the pharmacokinetics and pharmacodynamics of IM-101, with follow-up visits scheduled according to the dosing timeline.
CONDITIONS
Brief Title
A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide signed informed consent
- Willingness 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 the treatment of myasthenia gravis
- Body weight 6 40 kg at screening
- Vaccinated against meningococcal infection, streptococcus pneumoniae, and haemophilus influenzae type B
You will not qualify if you...
- Previous exposure to IM-101
- Anti-MuSK antibody positive
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 12 weeks
Participants receive IM-101 or placebo intravenously at loading doses on Day 1 and Day 15, followed by maintenance doses on Day 29. In Part B, additional maintenance doses are given on Day 57 and Day 85.
5 to 6 visits (in-person) depending on cohort assignment
Duration - Up to approximately 12 weeks
Participants are monitored for safety and efficacy outcomes for up to 70 to 84 days after the last dose of study drug depending on the study part.
Periodic visits during follow-up
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
Research Team
I
ImmunAbs Clinical Team
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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