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

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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

NCT04680676•Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18\* years and ≤ 75 years at screening, males or females
•\-- Except in countries where the minimum age of consent is greater than 18, in which case the minimum age is the minimum age of consent.
•Signed and dated written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
•Have Psoriatic Arthritis (PsA) symptoms for ≥ 6 months prior to screening, as assessed by the investigator
•Have PsA on the basis of the Classification Criteria for Psoriatic Arthritis (CASPAR) with peripheral symptoms at screening visit, as assessed by the investigator
•Have ≥ 3 tender joints and ≥ 3 swollen joints at screening and randomisation visits, as assessed by the investigator
•At least one Psoriasis (PsO) skin or nail lesion or a documented personal history of PsO at screening, as assessed by the investigator
•If patients receive concurrent PsA treatments, these need to be on stable doses as below:
•* For patients receiving Methotrexate (MTX): patient has received treatment for ≥ 3 months, with stable dose and stable route of administration for ≥ 4 weeks prior to randomisation to End Of Observation (EOO); patients on MTX should be taking folic acid supplementation according to local standard of care before randomisation and during the trial to minimize the likelihood of MTX associated toxicity
•* For patients receiving oral corticosteroids: the patient must be on a stable dose for ≥ 2 weeks prior to randomisation to EOO
+3 more criteria

Exclusion Criteria

•Major chronic inflammatory or connective tissue disease other than PsA (e.g. rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, Lyme disease, gout) or fibromyalgia, as assessed by the investigator
•Active uveitis or uveitis within 4 weeks prior to randomisation, assessed by the investigator
•Suspected or diagnosed inflammatory bowel disease, assessed by the investigator
•Previous exposure to BI 730357
•Prior use of any therapeutic agent directly targeted to Interleukin (IL)-12/23, IL-23 or IL-17
•Prior use of more than two different Tumor necrosis factor inhibitor (TNFi) agents
•Use of the following treatments:
•* TNFi agents (including, infliximab, adalimumab, certolizumab pegol or golimumab) within 8 weeks prior to randomisation
•* Etanercept within 4 weeks prior to randomisation
•* Leflunomide without cholestyramine wash-out within 8 weeks prior to randomisation
+5 more criteria

Key Dates

Start Date

May 2, 2022

Primary Completion Date

June 26, 2023

Completion Date

September 25, 2023

Last Updated

November 8, 2021

Conditions

Arthritis, Psoriatic

Interventions

BI 730357

DRUG

Placebo

DRUG

Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis

NCT06522035

Arthritis, Psoriatic

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NOT_YET_RECRUITING

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NCT06718569

ArthritisArthritis, Juvenile Idiopathic+4 more

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis

Pain in Inflammatory Joint Diseases

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A Study of Guselkumab in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNF Alpha) Therapy

Psoriatic Arthritis Pathobiology and Its Relationship With Clinical Disease Activity

Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis