A study to test different doses of BI 730357 and find out the effect they have on symptoms in people with active psoriatic arthritis

Phase 2

• Conditions: Psoriatic Arthritis; Inflammatory and Immune System - Rheumatoid arthritis; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12620001092987
• Lead Sponsor: Boehringer Ingelheim Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-20
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Males or females, aged >/= 18 years and <= 75 years at screening
- Have PsA symptoms for at least 6 months prior to screening, as assessed by the investigator
- Have PsA on the basis of the CASPAR with peripheral symptoms at screening visit, as assessed by the investigator
- Have at least 3 tender joints and at least 3 swollen joints at screening and randomisation visits, as assessed by the investigator
- At least one PsO skin or nail lesion or a documented personal history of PsO at screening, as assessed by the investigator
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

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 disease 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 IL-12/23, IL-23 or IL-17
- Prior use of more than two different TNFi agents

Study & Design

• Study Type: Interventional
• Study Design: Not specified