Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria

Summary

Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects with Chronic Spontaneous Urticaria

Timeline

Start

2023-09-25

Primary completion

2024-12-18

Completion

2025-01-16

Outcome

Missed primary endpoint

Stopped (Business): “Strategic Business Decision”

registry analysis (superiority test); Placebo vs EP262 50 mg; p = 0.4059; Least Square Mean Difference (LSMD) 1.99 (90% CI -1.96 to 5.94); MMRM NCT06077773 ↗

registry analysis (superiority test); Placebo vs EP262 150 mg; p = 0.5213; LSMD -1.53 (90% CI -5.49 to 2.42); MMRM NCT06077773 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	EP262	Unknown	25 mg	Oral
Subject	EP262	Unknown	50 mg	Oral
Subject	EP262	Unknown	150 mg	Oral

Indications