NCT04930562

Efficacy and Safety of BN101 in Subjects With Chronic Graft Versus Host Disease (cGVHD)

A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of BN101 in Subject With Chronic Graft Versus Host Disease (cGVHD) After at Least Fist Line of Systemic Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: BioNova Pharmaceuticals (Shanghai) LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, open-label, multicenter trial to evaluate the efficacy and safety of BN101 in subjects with Chronic Graft Versus Host Disease (cGVHD) after at least First Line of systemic therapy.

Detailed description

Approximately 30 subjects will be enrolled to receive orally administered BN101 200 mg QD (once daily) Study drug will be administered in 28-day cycles until disease progression or unacceptable toxicity. Subjects may receive study drug in the inpatient or outpatient setting. Curative Effect analysis The efficacy was analyzed based on MITT The point estimate and 95%CI of ORR were calculated based on the exact probability method of binomial distribution.If applicable, a logistic regression model will be used for multivariate analysis. Descriptive statistical analyses were provided for all secondary efficacy endpoints. The following subgroups will be analysed: * Severe cGVHD (Yes/No) * Number of organs involved (\<4 vs. ≥4) * Number of previous systemic cGVHD treatment (1 vs. ≥2) * Duration of cGVHD before inclusion (i.e., from the time of cGVHD diagnosis to the time of inclusion) * Lung Involvement (Yes/No)

Conditions

• GVHD, Chronic

Interventions

Type	Name	Description
DRUG	BN101	BN101 is an orally ROCK2 selective inhibitor

Timeline

• Start date: 2021-04-27
• Primary completion: 2022-06-10
• Completion: 2022-12-10
• First posted: 2021-06-18
• Last updated: 2024-01-17
• Results posted: 2023-11-01

Locations

7 sites across 1 country: China

Regulatory

• FDA-regulated drug study