A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
Recruiting now · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Myasthenia Gravis
In brief
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.
Key facts
- Study ID
- NCT07250750
- Run by
- ImmunAbs Inc.
- People needed
- 96
- Starts
- 2026-02-05
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-02-11
Who can join
Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Nerve & Muscle Center of Texas — Houston, Texas, United States (enrolling)
- Aqualane Clinical Research — Naples, Florida, United States (enrolling)
- SFM Clinical Research, LLC — Boca Raton, Florida, United States (enrolling)
- Neurology of Central Florida Research Center, LLC — Altamonte Springs, Florida, United States (enrolling)
- Houston Methodist Neurological Institute — Houston, Texas, United States
- Medical Center Hera - branch Montana — Montana, Bulgaria
- "MHAT Avis - Medica" OOD — Pleven, Bulgaria
- UMHAT 'Dr. Georgi Stranski', EAD — Pleven, Bulgaria
- UMHAT 'Tsaritsa Yoanna - ISUL', EAD — Sofia, Bulgaria
- Haelan Care 4 Medical Center EOOD — Varna, Bulgaria
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) — Brescia, Brescia, Italy
- Ospedale San Raffaele — Milan, Milano, Italy
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Milano, Italy
- Neurologia Slaska Centrum Medyczne — Katowice, Poland
- Twoja Przychodnia NCM — Nowa Sól, Poland
- Twoja Przychodnia PCM — Poznan, Poland
- NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy — Poznan, Poland
- Samodzielny Publiczny Szpital Kliniczny nr 1 im. Prof. Stanislawa Szyszko, SUM — Zabrze, Poland
- General Hospital MSB Medical System Belgrade — Belgrade, Serbia
- Hospital Universitario Clinico San Carlos — Madrid, Madrid, Spain
- Hospital Universitario La Paz — Madrid, Madrid, Spain
- Clinica Universidad de Navarra — Pamplona, Navarre, Spain
- Medsol Clinical Research Center — Port Charlotte, Florida, United States
- University of South Florida — Tampa, Florida, United States
- University of Kansas Medical Center Research Institute, Inc. — Kansas City, Missouri, United States
Full record on ClinicalTrials.gov
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