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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522406-20-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A MAD Cohort 1 | Experimental | IM-101 Low dose or Placebo |
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| Part A MAD Cohort 2 | Experimental | IM-101 Mid dose or Placebo |
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| Part A MAD Cohort 3 | Experimental | IM-101 High dose or Placebo |
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| Part A MAD Cohort 4 (Optional) | Experimental | IM-101 or Placebo if additional dose is needed per IDMC decision |
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| Part B Expansion AChR positive gMG | Experimental | IM-101 or Placebo |
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| Part B Expansion AChR negative gMG | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IM-101 Part A | Drug | Participants will receive IM-101 intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose and Day 29. |
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| Measure | Description | Time Frame |
|---|---|---|
| [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 | 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. | From first dose of study drug (Day 1) up to 70 days after the last dose of study drug, up to approximately 99 days. |
| [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 | 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. | From first dose of study drug (Day 1) up to 84 days after the last dose of study drug, up to approximately 169 days. |
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Inclusion Criteria:
Exclusion Criteria:
Full eligibility criteria is available in the study protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ImmunAbs Clinical Team | Contact | 82-2-6951-0584 | info@immunabs.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology of Central Florida Research Center, LLC | Recruiting | Altamonte Springs | Florida | 32714 | United States |
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IM-101 or Placebo
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| Part B Expansion oMG | Experimental | IM-101 or Placebo |
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| Placebo Part A | Drug | Participants will receive Placebo intravenously (IV), at a loading dose on Day 1 and Day 15 followed by maintenance dose on Day 29. |
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| IM-101 Part B | Drug | 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. |
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| Placebo Part B | Drug | 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. |
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| [Part B] Change from baseline to Week 16 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score for gMG cohorts | 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. | Baseline, Week 16 |
| [Part B]Change from baseline to Week 16 in Myasthenia Gravis Impairment Index (MGII) ocular score for oMG cohorts | 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. | Baseline, Week 16 |
| SFM Clinical Research, LLC | Recruiting | Boca Raton | Florida | 33487 | United States |
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| Aqualane Clinical Research | Recruiting | Naples | Florida | 34105 | United States |
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| Medsol Clinical Research Center | Not yet recruiting | Port Charlotte | Florida | 33952 | United States |
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| University of South Florida | Not yet recruiting | Tampa | Florida | 33612 | United States |
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| University of Kansas Medical Center Research Institute, Inc. | Not yet recruiting | Kansas City | Missouri | 66103 | United States |
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| Nerve & Muscle Center of Texas | Recruiting | Houston | Texas | 77030 | United States |
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| Houston Methodist Neurological Institute | Not yet recruiting | Houston | Texas | 77070 | United States |
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| Medical Center Hera - branch Montana | Not yet recruiting | Montana | 3400 | Bulgaria |
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| "MHAT Avis - Medica" OOD | Not yet recruiting | Pleven | 5800 | Bulgaria |
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| UMHAT 'Dr. Georgi Stranski', EAD | Not yet recruiting | Pleven | 5800 | Bulgaria |
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| UMHAT 'Tsaritsa Yoanna - ISUL', EAD | Not yet recruiting | Sofia | 1527 | Bulgaria |
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| Haelan Care 4 Medical Center EOOD | Not yet recruiting | Varna | 9009 | Bulgaria |
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| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) | Not yet recruiting | Brescia | Brescia | 25123 | Italy |
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| Ospedale San Raffaele | Not yet recruiting | Milan | Milano | 20132 | Italy |
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| Fondazione IRCCS Istituto Neurologico Carlo Besta | Not yet recruiting | Milan | Milano | 20133 | Italy |
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| Neurologia Slaska Centrum Medyczne | Not yet recruiting | Katowice | 40-689 | Poland |
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| Twoja Przychodnia NCM | Not yet recruiting | Nowa Sól | 67-100 | Poland |
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| Twoja Przychodnia PCM | Not yet recruiting | Poznan | 60-324 | Poland |
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| NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy | Not yet recruiting | Poznan | 61-853 | Poland |
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| Samodzielny Publiczny Szpital Kliniczny nr 1 im. Prof. Stanislawa Szyszko, SUM | Not yet recruiting | Zabrze | 41-800 | Poland |
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| General Hospital MSB Medical System Belgrade | Not yet recruiting | Belgrade | 11000 | Serbia |
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| Hospital Universitario Clinico San Carlos | Not yet recruiting | Madrid | Madrid | 28040 | Spain |
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| Hospital Universitario La Paz | Not yet recruiting | Madrid | Madrid | 28046 | Spain |
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| Clinica Universidad de Navarra | Not yet recruiting | Pamplona | Navarre | 31008 | Spain |
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| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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