Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

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

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-23

Study Completion Date

2024-06-06

Brief Summary

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

Extended Treatment and Follow-up of Subjects Treated with Belumosudil in Study KD025-208 or Study KD025-213

Related Clinical Trials

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

A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease

NCT02841995

Graft vs Host Disease

COMPLETED PHASE2

A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)

NCT07135973

Chronic Graft Versus Host Disease

NOT_YET_RECRUITING PHASE4

Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy

NCT03640481

Chronic Graft-versus-host-disease

TERMINATED PHASE2

Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease

NCT06046248

Chronic Graft Versus Host Disease

RECRUITING PHASE2

Safety and Efficacy of Oral Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander Male and Female Participants Aged 12 Years and Above With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy

NCT05567406

Chronic Graft Versus Host Disease

RECRUITING PHASE2

Detailed Description

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

This is a Phase 2, open-label, long-term treatment and follow-up study in subjects with cGVHD who have been previously treated with belumosudil in Study KD025-208 or Study KD025-213. Subjects will not be screened. Subjects who have signed the informed consent form will be enrolled in Study KD025-217 if they have met 1 of the following conditions:

* Actively receiving belumosudil or in long-term follow-up (LTFU) in Study KD025-208 or Study KD025-213
* Enrolled in the Companion Study as specified in Study KD025-213 Amendment 2 and received at least 6 months of treatment or is in LTFU

Approximately 20 Study Centers will participate with approximately 70 subjects participating overall.

Conditions

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

Chronic Graft-versus-host-disease

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

Study Groups

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

Arm A: belumosudil 200 mg QD

The assigned arm is per the previous study KD025-213 or study KD025-208

Group Type EXPERIMENTAL