NCT07250750RecruitingPhase 1/2
A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
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
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 26 Oct 2025
- Start date
- 5 Feb 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- ImmunAbs Inc.
- Diseases
- Myasthenia gravis
- NCT number
- NCT07250750
- EU CT number
- 2025-522406-20-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 96
- From 5 Feb 2026 to the primary completion date, Dec 2027
- 26 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous exposure to IM-101
- Anti-MuSK antibody Positive
- 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.
Other illness
- History of malignant thymoma, or history of cancer within the past 5 years of screening
- History of N. meningitidis infection
Who the study is looking for
- 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
Age in the registry: 18 years to 74 years · Sex: All · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Center Hera EOOD Coordinator of this site? Confirm its status | Montana | Bulgaria | Recruiting |
| University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Recruiting |
| Multiprofile Hospital For Active Treatment Avis Medika OOD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Recruiting |
| Medical Center Neurocentrum EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Haelan Care 4 Medical Center Ltd. Coordinator of this site? Confirm its status | Varna | Bulgaria | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Neurologia Śląska Centrum Medyczne Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Nowa Sol | Poland | Recruiting |
| Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Ilkowski I Partnerzy sp.p. Lekarzy Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| General Hospital MSB Medical System Belgrade Coordinator of this site? Confirm its status | Belgrade | Serbia | Not yet recruiting |
| Neurology of Central Florida Research Center LLC Coordinator of this site? Confirm its status | Altamonte Springs | United States | Recruiting |
| SFM Clinical Research LLC Coordinator of this site? Confirm its status | Boca Raton | United States | Recruiting |
| Houston Methodist Neurological Institute Coordinator of this site? Confirm its status | Houston | United States | Not yet recruiting |
| Nerve & Muscle Center of Texas Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Kansas Medical Center Research Institute, Inc Coordinator of this site? Confirm its status | Kansas City | United States | Not yet recruiting |
| Aqualane Clinical Research Coordinator of this site? Confirm its status | Naples | United States | Recruiting |
| Medsol Clinical Research Center Coordinator of this site? Confirm its status | Port Charlotte | United States | Not yet recruiting |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.