A Phase 1 Study of ABC008 in Ascending (Single Ascending Dose/Multiple Ascending Dose) Study in Patients With (IBM)

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-25

Study Completion Date

2025-01-10

Brief Summary

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

An open-label, ascending dose study for adult patients with Inclusion Body Myositis (IBM).

Related Clinical Trials

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

A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis

NCT05721573

Inclusion Body Myositis

COMPLETED PHASE2/PHASE3

Long-term Extension Study of Ulviprubart (ABC008) in Subjects With Inclusion Body Myositis

NCT06450886

Inclusion Body Myositis (IBM)

ACTIVE_NOT_RECRUITING PHASE2/PHASE3

Immune Abnormalities in Sporadic Inclusion Body Myositis

NCT00030212

Sporadic Inclusion Body Myositis

COMPLETED

Arimoclomol in Sporadic Inclusion Body Myositis

NCT00769860

Inclusion Body Myositis

COMPLETED PHASE2/PHASE3

Sporadic Inclusion Body Myositis Natural History Study

NCT05046821

Sporadic Inclusion Body Myositis Inclusion Body Myositis

ACTIVE_NOT_RECRUITING

Detailed Description

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

Participants who successfully complete the SAD EOT visit, and have no emerging safety issues, will be eligible to enroll in Part 2 (MAD). Eligible participants for the MAD part will have inclusion and exclusion criteria (same as those for Part 1) reviewed prior to dosing on MAD Day 1.

Participants who successfully complete the MAD EOT visit, and have no emerging safety issues, will be eligible to enrol in Part 3, MAD Extension.

After the final MAD visit (W48), participants will have the option to continue on to Part 3 MAD Extension.

For Part 3 (MAD Extension), participant dosing will be at 8-week intervals starting at Day 1. Duration of dosing in Part 3 will be up to approximately 80 weeks (18 months), or until a new long-term extension study has been initiated. The SMC will review all participant safety data approximately every 6 months while the Part 3 dosing continues.

Conditions

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

Inclusion Body Myositis

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

ABC008

Interventions

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

ABC008

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Diagnosis of either clinico-pathologically defined IBM, clinically defined IBM, or probable IBM according to the European Neuromuscular Center (ENMC) IBM 2011
* Able to arise from a chair (with or without armrests) without support from another person or device
* Able to ambulate at least 20 feet / 6 meters with or without assistive device

Exclusion Criteria

* Taking \> 7.5 mg prednisolone (or equivalent) or on intravenous immunoglobulin (IVIg) or other immunosuppressants within the last 3 months. Topical, nasal, and ocular corticosteroids are allowed unless they are being widely applied or the severity of the underlying condition makes them unsuitable in the Investigator's opinion. Local steroid injections are allowed

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No