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Arthritis, PsoriaticPhase 2NCT04680676

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

A Phase 2 study testing BI 730357 in people with Arthritis, Psoriatic, run by Boehringer Ingelheim.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Arthritis, Psoriatic
What is being tested?
BI 730357
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
2 May 2022to 25 Sep 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

About this study

Official title: 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.

Being tested
BI 730357, Placebo
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 730357Drug

    BI 730357

  • PlaceboDrug

    Placebo

Study groups in NCT04680676
Study groupRoleWhat they receive
BI 730357 - low doseExperimentalNot described
Receives: Drug: BI 730357
BI 730357 - medium doseExperimentalNot described
Receives: Drug: BI 730357
BI 730357 - high doseExperimentalNot described
Receives: Drug: BI 730357
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at week 12

Secondary outcomes (10)

  1. ACR 50 response at Week 12

    ACR 50 is a binary outcome (Yes, No) with 'yes' indicating improvements of the symptoms.

    Measured: at week 12

  2. ACR 70 response at Week 12

    ACR 70 is a binary outcome (Yes, No) with 'yes' indicating improvements of the symptoms.

    Measured: at week 12

  3. 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.

    Measured: at week 12

  4. 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.

    Measured: at week 12

  5. 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.

    Measured: at week 12

  6. 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.

    Measured: at week 12

  7. Adverse Events

    Measured: up to 14 weeks

  8. Treatment Emergent Adverse Events

    Measured: up to 14 weeks

  9. Serious Adverse Events

    Measured: up to 14 weeks

  10. 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.

    Measured: up to 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2020
  2. Study start2 May 2022 (estimated)
  3. Primary completion26 Jun 2023 (estimated)
  4. Study completion25 Sep 2023 (estimated)

Why it stopped: Program discontinued

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04680676
Sponsor's protocol ID
1407-0004
Other IDs
2019-003182-17, 2019
Status last verified
Nov 2021
First submitted
13 Nov 2020
Last updated
8 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 730357 in people with Arthritis, Psoriatic, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

American College of Rheumatology (ACR) 20 response at week 12 (time frame: at week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04680676.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.

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