Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
Study NCT ID:
NCT05272059
Status:
WITHDRAWN
Last Update Posted:
2023-04-07
First Post:
2022-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multiple Ascending Dose Study of MHS552 in Adults With Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-04-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-05', 'studyFirstSubmitDate': '2022-02-28', 'studyFirstSubmitQcDate': '2022-02-28', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)', 'timeFrame': 'Part A: up to 12 weeks; Part B: up to 20 weeks', 'description': 'Numbers of participants with AEs and SAEs including vital signs, electrocardiograms (ECG) and laboratory results'}], 'secondaryOutcomes': [{'measure': 'Area Under Plasma Concentration-time Curve calculated to the end of a dosing interval (AUCtau) for MHS552', 'timeFrame': 'Part A: up to Day 78; Part B: up to Day 134', 'description': 'Characterize the AUCtau profile following multiple doses of MHS552'}, {'measure': 'Maximum ObservBlood Concentrations (Cmax) for MHS552', 'timeFrame': 'Part A: up to Day 78; Part B: up to Day 134', 'description': 'Characterize the Cmax profile following multiple doses of MHS552'}, {'measure': 'Time to Reach Maximum Blood Concentrations (Tmax) of MHS552', 'timeFrame': 'Part A: up to Day 78; Part B: up to Day 134', 'description': 'Characterize the Tmax profile following multiple doses of MHS552'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['type 1 diabetes mellitus, T1DM'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this two-part multiple ascending dose study is to evaluate the safety and tolerability of multiple doses of MHS552 in adults with type 1 diabetes mellitus. Participants will be treated for 4 or 12 weeks followed by an 8 week follow-up period', 'detailedDescription': 'This is a Phase 1b, randomized, investigator and participant blinded, placebo controlled, multiple ascending dose (MAD) study in adults with type 1 diabetes mellitus (adults aged 18-45 years, inclusive, diagnosed with T1DM within 5 years at the time of screening). This MAD study will be conducted in two sequential parts, Part A and Part B.\n\nIn Part A, after an screening period of up to 28 days, participants will be randomized (in a 3:1 ratio) to MHS552 or placebo administered subcutaneously (s.c.) weekly for four weeks of treatment. Part A will consist of up to 3 cohorts (low, medium, high dose), with approximately 4-8 participants completing each cohort (total of approximately 16 participants). Participants will be followed-up during 8 weeks post last dose. The total duration of study participation of Part A is approximately 106 Days.\n\nIn Part B, after a screening period of up to 28 days, approximately 12 participants will be randomized (in a 2:1 ratio) to MHS552 or placebo administered s.c. weekly for 12 weeks of treatment (dose level 4). Participants will be followed-up during 8 weeks post last dose with End of Study (EoS) visit at Day 134. The total duration of study participation of Part B is approximately 162 Days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult men and women ages 18 to 45, inclusive, body weight between ≥40 to ≤150 kg, inclusive, with T1DM, a maximum of 5 years from T1DM diagnosis at screening.\n* Evidence of one or more T1DM autoantibody(ies) including glutamic acid decarboxylase (anti GAD), protein tyrosine, phosphatase-like protein (anti-IA-2); zinc transporter 8 (anti-ZnT8); islet cell (cytoplasmic) (anti-ICA)\n* Residual pancreatic β-cell function (fasting C-peptide \\>100 pmol/L \\[0.30 ng/mL\\] or random C peptide \\>200 pmol/L \\[0.60 ng/mL\\])\n\nExclusion Criteria:\n\n* History of hypersensitivity to drugs of similar biological class, IL-2 protein analogues, or immunoglobulin (IgG1) proteins, hypersensitivity to any components of the study drug, or history of severe hypersensitivity reaction or anaphylaxis to biological agents, e.g. human monoclonal antibody.\n* Use of other investigational drugs or use of immunosuppressive agents at the time of enrollment, or within 5 half-lives of enrollment, or until the expected PD effect has returned to baseline, whichever is longer; or longer if required by local regulations.\n* Diabetes forms other than autoimmune type 1 such as maturity-onset diabetes of the young (MODY), latent autoimmune diabetes of the adult (LADA), acquired diabetes (secondary to medications or surgery), type 2 diabetes by judgement of the investigator.\n* Diabetic ketoacidosis within 2 weeks.\n* Polyglandular auto-immune disease, including but not limited to: Addison's disease, pernicious anemia, celiac sprue and psoriasis. Treated, stable Hashimoto's thyroiditis is not exclusionary.\n* History of capillary leak syndrome (CLS).\n* Ongoing, and up to 2 weeks prior to screening, initiation of medications or change in dose of medications that may affect glucose control (e.g, systemic steroids, thiazides, beta blockers).\n\nOther protocol-defined inclusion/exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT05272059', 'briefTitle': 'Multiple Ascending Dose Study of MHS552 in Adults With Type 1 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Investigator and Participant Blinded, Placebo Controlled, Multiple Ascending Dose, Two Part Design Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of MHS552 in Adults With Type 1 Diabetes Mellitus (T1DM)', 'orgStudyIdInfo': {'id': 'CMHS552B12101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Cohort 1 - MHS552 low dose', 'description': 'Participants will receive MHS552 low dose once weekly subcutaneously for 4 weeks', 'interventionNames': ['Drug: MHS552']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A: Cohort 1, 2, 3 - Placebo', 'description': 'Participants will receive placebo once weekly subcutaneously for 4 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Cohort 2 - MHS552 medium dose', 'description': 'Participants will receive MHS552 medium dose once weekly subcutaneously for 4 weeks', 'interventionNames': ['Drug: MHS552']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Cohort 3 - MHS552 high dose', 'description': 'Participants will receive MHS552 high dose once weekly subcutaneously for 4 weeks', 'interventionNames': ['Drug: MHS552']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: MHS552', 'description': 'Participants will MHS552 (dose to be determined) once weekly subcutaneously for 12 weeks', 'interventionNames': ['Drug: MHS552']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: Placebo', 'description': 'Participants will receive placebo once weekly subcutaneously for 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MHS552', 'type': 'DRUG', 'description': 'MHS552 will be administered once weekly as subcutaneous injection for 4 (Part A) or 12 weeks (Part B)', 'armGroupLabels': ['Part A: Cohort 1 - MHS552 low dose', 'Part A: Cohort 2 - MHS552 medium dose', 'Part A: Cohort 3 - MHS552 high dose', 'Part B: MHS552']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered once weekly as subcutaneous injection for 4 (Part A) or 12 weeks (Part B)', 'armGroupLabels': ['Part A: Cohort 1, 2, 3 - Placebo', 'Part B: Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}