A Study of Imvotamab in Active, Refractory Idiopathic Inflammatory Myopathies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-29

Study Completion Date

2025-01-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM)

NCT00106184

Myositis Dermatomyositis Polymyositis +1 more

COMPLETED PHASE2

A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Idiopathic Inflammatory Myopathy (IIM)

NCT07284797

Healthy Idiopathic Inflammatory Myopathies

NOT_YET_RECRUITING PHASE1

Treatment With TNF Blockade, Infliximab, in Patients With Myositis

NCT00443222

Refractory Myositis

COMPLETED PHASE2/PHASE3

Phase 2 Study of Rapcabtagene Autoleucel in Myositis

NCT06665256

Idiopathic Inflammatory Myopathies

RECRUITING PHASE2

Rituximab for the Treatment of Refractory Inflammatory Myopathies and Refractory Myasthenia Gravis

NCT00774462

Myositis Myasthenia Gravis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Idiopathic Inflammatory Myopathies Inflammatory Myopathies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Imvotamab (Dose Escalation)

Imvotamab administered intravenously

Group Type EXPERIMENTAL

Imvotamab

Intervention Type DRUG

Administered intravenously

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Imvotamab

Administered intravenously

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No