NCT04227938

ALPN-101 in Steroid-resistant or Steroid-refractory Acute GVHD

An Open-label Study of ALPN-101 in Steroid-resistant or Steroid-refractory Acute Graft Versus Host Disease (aGVHD)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Alpine Immune Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Balance study will assess the safety, tolerability, and efficacy of an investigational drug called ALPN-101 in adults with steroid-resistant or steroid-refractory acute graft versus host disease (aGVHD).

Detailed description

AIS-A02 is a Phase 1b open-label study of ALPN-101 administered to adult subjects with steroid-resistant or steroid-refractory acute graft versus host disease (aGVHD). It will be conducted at approximately 10 US sites. Up to 72 subjects will be enrolled in Part A (dose escalation) and up to 25 subjects will be enrolled in Part B (dose expansion). In each Part, safety and efficacy assessments will be performed throughout the dosing and follow-up periods, and multiple PK and PD samples will be collected.

Conditions

• Graft Vs Host Disease

Interventions

Type	Name	Description
DRUG	ALPN-101	A single dose of ALPN-101 will be administered via intravenous infusion.

Timeline

• Start date: 2020-05-11
• Primary completion: 2020-05-21
• Completion: 2020-05-21
• First posted: 2020-01-14
• Last updated: 2023-08-28

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study