NCT04680676

A Study to Test Different Doses of BI 730357 and Find Out Whether They Reduce Symptoms in People With Active Psoriatic Arthritis

A Phase II, Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging, Proof-of-concept Trial of BI 730357 Given for 12 Weeks in Patients With Active Psoriatic Arthritis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults with active psoriatic arthritis who have tender and swollen joints. The purpose of this study is to find out whether a medicine called BI 730357 helps to reduce symptoms and to prevent damage to joints. Three different doses of BI 730357 are tested. Participants are put into 4 groups by chance. Participants in 3 of the 4 groups take BI 730357. Participants in the fourth group take placebo. Participants take BI 730357 or placebo as tablets once a day. Placebo tablets look like BI 730357 tablets but do not contain any medicine. Participants are in the study for about 4.5 months. During this time, they visit the study site about 8 times. At these visits, doctors check whether the swelling of inflamed joints has changed. The results between the BI 730357 and placebo groups are then compared. Doctors also regularly check the general health of the participants.

Conditions

• Arthritis, Psoriatic

Interventions

Type	Name	Description
DRUG	BI 730357	BI 730357
DRUG	Placebo	Placebo

Timeline

• Start date: 2022-05-02
• Primary completion: 2023-06-26
• Completion: 2023-09-25
• First posted: 2020-12-23
• Last updated: 2021-11-08

Regulatory

• FDA-regulated drug study