NCT04499235

A Study to Assess the Therapeutic Effect and Safety of Adjunctive AKST4290 in Subjects With Bullous Pemphigoid

Double-Blind, Randomized, Placebo-Controlled Trial of AKST4290 for Adjunctive Treatment of Mild to Moderate Bullous Pemphigoid

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Alkahest, Inc. · Industry
• Sex: All
• Age: 60 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the therapeutic effect and safety of adjunctive AKST4290 in subjects with bullous pemphigoid (BP).

Detailed description

This is a randomized, double-blind, placebo-controlled study to assess the therapeutic effect and safety of adjunctive AKST4290 in subjects with bullous pemphigoid (BP). Subjects will receive topical mometasone furoate cream (MFC) therapy concurrently with study agent (placebo or AKST4290) in an inpatient setting until disease control is reached (duration of inpatient stay is dependent upon individual disease course, but is estimated between 1-3 weeks). Subjects will receive rescue therapy at any time if their clinical condition worsens or if their clinical condition fails to improve by the completion of Week 1 on study treatment, as assessed by the investigator. Rescue therapy will consist of whole-body clobetasol propionate cream (CPC) (15-50g) and/or oral prednisone (0.5 mg/kg per day), as determined by the investigator. Subjects who receive rescue therapy will remain in the study until disease control, unless they are withdrawn or withdraw from participation.

Conditions

• Pemphigoid, Bullous

Interventions

Type	Name	Description
DRUG	Mometasone furoate	Topical mometasone furoate
DRUG	AKST4290	Oral AKST4290
DRUG	Placebo	Oral placebo

Timeline

• Start date: 2020-01-30
• Primary completion: 2021-03-29
• Completion: 2021-04-14
• First posted: 2020-08-05
• Last updated: 2023-09-14
• Results posted: 2023-09-14

Locations

8 sites across 1 country: Germany