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

Kadmon

Status and phase: Completed; Phase 2

Conditions: Chronic Graft-versus-host-disease

Treatments: Drug: Belumosudil 200 mg BID; Drug: Belumosudil 400 mg QD; Drug: Belumosudil 200 mg QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT05305989

LTS17660

KD025-217

U1111-1279-2612 (Registry Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects must have been treated with belumosudil for at least 1 of the following:

• Actively receiving belumosudil on Study KD025-208 or Study KD025-213
• Is in Long-term Follow-up (LTFU) on Study KD025-208 or Study KD025-213. Long-term Follow-up will be defined as the period after ending treatment with belumosudil and until a FFS event occurs.
• Adult enrolled in the Companion Study under KD025-213 Amendment 2 (01 June 2020) and has received at least 6 months of treatment of belumosudil or is in LTFU

Exclusion criteria

• Female subject who is pregnant or breastfeeding
• Subject considered unlikely to adhere to treatment and/or follow protocol in the opinion of the Investigator

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 3 patient groups

Arm A: belumosudil 200 mg QD

Experimental group

Description:

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

Treatment:

Drug: Belumosudil 200 mg QD

Arm B: belumosudil 200 mg BID

Experimental group

Description:

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

Treatment:

Drug: Belumosudil 200 mg BID

Arm C: belumosudil 400 mg QD

Experimental group

Description:

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

Treatment:

Drug: Belumosudil 400 mg QD