A Study of Imvotamab in Active, Refractory Idiopathic Inf... | NCT06524687

Studies
A Study of Imvotamab in Active, Refractory Idiopathic Inflammatory Myopathies

NCT06524687

Sponsor

IGM Biosciences, Inc.

Status

Terminated

Last Update Posted

Feb 11, 2025Actual

Enrollment

2Actual

Phase

Phase 1

Conditions

Idiopathic Inflammatory Myopathies
Inflammatory Myopathies

Interventions

Imvotamab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Program Discontinuation

Expanded Access Info

Start Date

May 29, 2024Actual

Primary Completion Date

Jan 21, 2025Actual

Completion Date

Jan 21, 2025Actual

First Submitted Date

Jul 23, 2024

First Submission Date that Met QC Criteria

Jul 26, 2024

First Posted Date

Jul 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2025

Last Update Posted Date

Feb 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the safety and tolerability of imvotamab in patients with Moderate-Severe Idiopathic Inflammatory Myopathies who have failed prior therapies.

Participants will be given imvotamab through a vein (i.e., intravenously).

Detailed Description

This is a Phase 1b, open-label study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of imvotamab in adult participants with active, refractory, moderate-severe Idiopathic Inflammatory Myopathies. Approximately 5-10 participants will be assigned.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Imvotamab (Dose Escalation)	Experimental	Imvotamab administered intravenously	Drug: Imvotamab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imvotamab	Drug	Administered intravenously	Imvotamab (Dose Escalation)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability of imvotamab	Incidence of adverse events (AEs), serious adverse events (SAEs), including serious	Time Frame: Up to Week 50

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Age ≥ 18 years at the time of signing ICF
Diagnosis of probable or definite IIM according to the 2017 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for IIM with subgroup classification of either DM, polymyositis (PM), anti-synthetase syndrome, or immune-mediated necrotizing myositis (IMNM).
Active IIM despite treatment with corticosteroids and at least 1 immunosuppressive or immunomodulatory standard-of-care agent determined at the discretion of the investigator after at least 3 months of treatment.
If using oral corticosteroids (OCS), must be on a stable dose equivalent to ≤ 30 mg/day of prednisone for at least 4 weeks prior to first study treatment

Key Exclusion Criteria:

Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of imvotamab.
Receipt of an investigational therapy less than 12 weeks or 5 drug-elimination half-lives (whichever is longer) prior to first administration of study treatment and during the study.
Has inclusion body myositis or myositis-associated with other connective tissue disease.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009220	Myositis
D009135	Muscular Diseases

ID	Term
D009140	Musculoskeletal Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases