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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Able and willing to provide signed willing to sign a consent form 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 Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

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.

Locations (20)

Neurology of Central Florida Research Center, LLC
Altamonte Springs, Florida, United States
SFM Clinical Research, LLC
Boca Raton, Florida, United States
Aqualane Clinical Research
Naples, Florida, United States
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
Nerve & Muscle Center of Texas
Houston, Texas, United States
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