Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-28 @ 9:16 PM
Study NCT ID:
NCT07250750
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}], 'ancestors': [{'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-10-26', 'studyFirstSubmitQcDate': '2025-11-25', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '[Part A] Incidence of TEAEs, SAEs, AEs that led to premature discontinuation, and AESIs across 3 ascending dose regimens (each with 3 administrations) in participants with AChR antibody-positive gMG', 'timeFrame': 'From first dose of study drug (Day 1) up to 70 days after the last dose of study drug, up to approximately 99 days.', 'description': "An AE is any untoward medical occurrence in a clinical study participant administered with a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important. Treatment-emergent AEs associated with a. Grade \\> 2 hypersensitivity or IRR, b. Infection c. Any potential kidney failure and d. Any potential Hy's Law case (\\> 3 × ULN of either ALT/AST with concurrent \\> 2 × ULN of total bilirubin and lack of alternate etiology) will be considered AESIs."}, {'measure': '[Part B] Incidence of TEAEs, SAEs, AEs that led to premature discontinuation, and AESIs of IM-101, compared with placebo, in participants with AChR antibody-positive gMG, AChR antibody-negative gMG, and oMG', 'timeFrame': 'From first dose of study drug (Day 1) up to 84 days after the last dose of study drug, up to approximately 169 days.', 'description': "An AE is any untoward medical occurrence in a clinical study participant administered with a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important. Treatment-emergent AEs associated with a. Grade \\> 2 hypersensitivity or IRR, b. Infection c. Any potential kidney failure and d. Any potential Hy's Law case (\\> 3 × ULN of either ALT/AST with concurrent \\> 2 × ULN of total bilirubin and lack of alternate etiology) will be considered AESIs."}, {'measure': '[Part B] Change from baseline to Week 16 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score for gMG cohorts', 'timeFrame': 'Baseline, Week 16', 'description': "Change from baseline in MG-ADL total score over 16 Weeks will be reported. The MG-ADL provides a rapid assessment of the participant's MG symptom severity. Eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, eyelid droop) are rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score will be sum of eight function scores and can range from 0 to 24. A higher score indicates greater symptom severity."}, {'measure': '[Part B]Change from baseline to Week 16 in Myasthenia Gravis Impairment Index (MGII) ocular score for oMG cohorts', 'timeFrame': 'Baseline, Week 16', 'description': 'Change from baseline in MGII ocular score over 16 Weeks will be reported. The MGII is a scoring tool measuring disease severity. It consists of 22 patient-reported outcomes (PRO) and 6 physical examinations (PE). The Ocular PRO score varies between 0 and 18. The higher the score, the more severe the disease.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IM-101', 'Myasthenia Gravis', 'C5 inhibitor'], 'conditions': ['Myasthenia Gravis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able and willing to provide signed informed consent\n2. Willingness to consent to screening for genetic muscular diseases\n3. Male or female aged ≥ 18 years and \\< 75 years\n4. Diagnosed with MG\n5. On a stable dose of background therapy for the treatment of MG\n6. Body weight ≥ 40 kg at screening\n7. Vaccinated against meningococcal infection (Neisseria meningitidis), streptococcus pneumoniae, and haemophilus influenzae type B\n\nExclusion Criteria:\n\n1. Previous exposure to IM-101\n2. Anti-MuSK antibody Positive\n3. History of malignant thymoma, or history of cancer within the past 5 years of screening\n4. History of N. meningitidis infection\n5. Has been treated with any complement inhibitor, but failed due to intolerability or lack of efficacy\n\nFull eligibility criteria is available in the study protocol.'}, 'identificationModule': {'nctId': 'NCT07250750', 'acronym': 'Synergy-MG', 'briefTitle': 'A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis', 'organization': {'class': 'INDUSTRY', 'fullName': 'ImmunAbs Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IM-101_MG_2.1'}, 'secondaryIdInfos': [{'id': '2025-522406-20-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A MAD Cohort 1', 'description': 'IM-101 Low dose or Placebo', 'interventionNames': ['Drug: IM-101 Part A', 'Drug: Placebo Part A']}, {'type': 'EXPERIMENTAL', 'label': 'Part A MAD Cohort 2', 'description': 'IM-101 Mid dose or Placebo', 'interventionNames': ['Drug: IM-101 Part A', 'Drug: Placebo Part A']}, {'type': 'EXPERIMENTAL', 'label': 'Part A MAD Cohort 3', 'description': 'IM-101 High dose or Placebo', 'interventionNames': ['Drug: IM-101 Part A', 'Drug: Placebo Part A']}, {'type': 'EXPERIMENTAL', 'label': 'Part A MAD Cohort 4 (Optional)', 'description': 'IM-101 or Placebo if additional dose is needed per IDMC decision', 'interventionNames': ['Drug: IM-101 Part A', 'Drug: Placebo Part A']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Expansion AChR positive gMG', 'description': 'IM-101 or Placebo', 'interventionNames': ['Drug: IM-101 Part B', 'Drug: Placebo Part B']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Expansion AChR negative gMG', 'description': 'IM-101 or Placebo', 'interventionNames': ['Drug: IM-101 Part B', 'Drug: Placebo Part B']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Expansion oMG', 'description': 'IM-101 or Placebo', 'interventionNames': ['Drug: IM-101 Part B', 'Drug: Placebo Part B']}], 'interventions': [{'name': 'IM-101 Part A', 'type': 'DRUG', 'description': 'Participants will receive IM-101 intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose and Day 29.', 'armGroupLabels': ['Part A MAD Cohort 1', 'Part A MAD Cohort 2', 'Part A MAD Cohort 3', 'Part A MAD Cohort 4 (Optional)']}, {'name': 'Placebo Part A', 'type': 'DRUG', 'description': 'Participants will receive Placebo intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose on Day 29.', 'armGroupLabels': ['Part A MAD Cohort 1', 'Part A MAD Cohort 2', 'Part A MAD Cohort 3', 'Part A MAD Cohort 4 (Optional)']}, {'name': 'IM-101 Part B', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Part B Expansion AChR negative gMG', 'Part B Expansion AChR positive gMG', 'Part B Expansion oMG']}, {'name': 'Placebo Part B', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Part B Expansion AChR negative gMG', 'Part B Expansion AChR positive gMG', 'Part B Expansion oMG']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ImmunAbs Clinical Team', 'role': 'CONTACT', 'email': 'info@immunabs.com', 'phone': '82-2-6951-0584'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ImmunAbs Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}