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

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.

Study Overview

• Status: Withdrawn
• Conditions: Arthritis, Psoriatic
• Intervention / Treatment: Drug: Placebo; Drug: BI 730357

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
  • For patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) or paracetamol/acetaminophen Pro re nata (PRN): the patient must be on stable dose for ≥ 2 weeks prior to randomisation to EOO
• Women of child-bearing potential (A woman is considered of childbearing potential, i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. Such methods should be used throughout the study and the patient must agree to periodic pregnancy testing during participation in the trial. There are no specific contraceptive requirements for male participants.

Patients (males or females) following the national regulatory guidelines regarding contraception if receiving MTX as background therapy.

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
  • Systemic non-biologic medications for PsA or PsO (including traditional Disease-Modifying Antirheumatic Drugs (DMARDs) apremilast, a Janus Kinase (JAK) inhibitor or leflunomide with cholestyramine wash-out) or photochemotherapy within 4 weeks prior to randomisation
  • Intraarticular injections (including steroids) and intramuscular or intravenous corticosteroid treatment within 4 weeks prior to randomisation
  • Topical PsO medications and phototherapy within 2 weeks prior to randomisation
  • Low and high potency opioid analgesics (e.g. tramadol, methadone, hydromorphone, morphine) within 2 weeks prior to randomisation
• Live vaccination ≤ 12 weeks prior to randomisation, or any plan to receive a live vaccination during the conduct of this study. Bacillus Calmette-Guérin (BCG) vaccination is restricted 1 year prior to randomisation through EOO visit.
• further exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo
EXPERIMENTAL: BI 730357 - low dose	Drug: BI 730357; BI 730357
EXPERIMENTAL: BI 730357 - medium dose	Drug: BI 730357; BI 730357
EXPERIMENTAL: BI 730357 - high dose	Drug: BI 730357; BI 730357

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American College of Rheumatology (ACR) 20 response at week 12	ACR 20 is a binary outcome (Yes, No) with 'yes' indicating improvements of the symptoms.	at week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACR 50 response at Week 12	ACR 50 is a binary outcome (Yes, No) with 'yes' indicating improvements of the symptoms.	at week 12
ACR 70 response at Week 12	ACR 70 is a binary outcome (Yes, No) with 'yes' indicating improvements of the symptoms.	at week 12
Change in Tender Joint Count at Week 12 as compared to baseline	Change in Tender Joint Count at Week 12 as compared to baseline, with a maximum possible range between -68 to 68 with higher values indicating a worsening of the symptoms.	at week 12
Change in Swollen Joint Count at Week 12 as compared to baseline	Change in Swollen Joint Count at Week 12 as compared to baseline, with a maximum possible range between -66 to 66 with higher values indicating a worsening of the symptoms.	at week 12
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 as compared to baseline	HAQ-DI score as compared to baseline with a maximum possible range between -3 and 3 with higher values indicating a worsening of the symptoms.	at week 12
Psoriasis Area and Severity Index (PASI)75 response at Week 12, assessed in patients with a ≥ 3% baseline Psoriasis (PsO) Body Surface Area (BSA)	PASI75 is a binary outcome (Yes, No) with 'Yes' indicating improvements of the symptoms.	at week 12
Adverse Events		up to 14 weeks
Treatment Emergent Adverse Events		up to 14 weeks
Serious Adverse Events		up to 14 weeks
Intensity of Adverse Events	Intensity of adverse events will be assessed by Rheumatology Common Toxicity Criteria (RCTC) version 2.0. The RCTC criteria consist of 4 grades (1 = mild to 4 = life-threatening) with higher grades indicating a worsening of the symptoms.	up to 14 weeks

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 2, 2022
• Primary Completion (ANTICIPATED): June 26, 2023
• Study Completion (ANTICIPATED): September 25, 2023

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (ACTUAL): December 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2021
• Last Update Submitted That Met QC Criteria: November 4, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: 1407-0004; 2019-003182-17 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

1. studies in products where Boehringer Ingelheim is not the license holder;
2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No