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A Study to Test How Well Patients With Plaque Psoriasis Tolerate BI 730357 Over a Longer Period and How Effective it is

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ClinicalTrials.gov Identifier: NCT03835481
Recruitment Status : Not yet recruiting
First Posted : February 8, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To assess long-term safety, tolerability, and efficacy of BI 730357 in patients with moderate to severe chronic plaque psoriasis.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: BI 730357 Drug: Placebo to match BI 730357 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Long-term Extension Study to Assess the Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis
Estimated Study Start Date : March 18, 2019
Estimated Primary Completion Date : January 23, 2020
Estimated Study Completion Date : April 10, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Placebo Comparator: Placebo
Blinded period of Placebo until Week 12
Drug: Placebo to match BI 730357
Film-coated tablet

Experimental: BI 730357
Blinded period of BI 730357 until Week 12 (4 dose levels or placebo as continued from trial 1407-0030). Open label period of BI30357 from Week 12 to end of trial (2 dose levels).
Drug: BI 730357
Film-coated tablet




Primary Outcome Measures :
  1. The exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE) [ Time Frame: Up to Week 288 ]

Secondary Outcome Measures :
  1. Achievement of Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 [ Time Frame: Up to Week 24 ]
  2. Achievement of Static Physician's Global Assessment (sPGA) score 0 (clear) or 1 (almost clear) [ Time Frame: Up to Week 24 ]
  3. Achievement of sPGA score 0 (clear) [ Time Frame: Up to Week 24 ]
  4. Time to loss of PASI50/PASI75/PASI90/PASI100 for patients who achieve the response [ Time Frame: Up to Week 288 ]
  5. Time to loss of sPGA clear or almost clear for patients who achieve the response [ Time Frame: Up to Week 288 ]
  6. Time to loss of sPGA clear for patients who achieve the response [ Time Frame: Up to Week 288 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Woman Of Child Bearing Potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly from date of screening until 4 weeks after last treatment in this trial. A list of contraception methods meeting these criteria is provided in the patient information.
  • Patients with moderate-to-severe plaque Psoriasis (PsO) who have completed the randomized treatment period without early treatment discontinuation in the preceding trial, achieved a PASI50 at Week 24 of the preceding trial, and are willing and able to continue treatment in this study.
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

Exclusion Criteria:

  • Nonplaque forms of PsO (including guttate, erythrodermic, or pustular), current druginduced PsO (including a new onset or exacerbation of PsO from, e.g., beta blockers, calcium channel blockers, lithium), active ongoing inflammatory diseases (including but not limited to inflammatory bowel disease (IBD)) other than PsO that might confound trial evaluations.
  • Previous enrolment in this trial.
  • Currently enrolled in another investigational device or drug trial or is receiving other investigational treatment(s) (with the exception of 1407-0030).
  • Intake of any restricted medication or any drug considered likely to interfere with the safe conduct of the trial.
  • Any plan to receive a live vaccination during the conduct of the trial.
  • Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled.
  • Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes the patient an unreliable trial participant or unlikely to complete the trial.
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
  • Any documented active or suspected malignancy, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix.
  • Relevant chronic or acute infections including human immunodeficiency virus (HIV), viral hepatitis, candidiasis and tuberculosis.
  • Evidence of a disease (including known or suspected IBD, cardiovascular disease), or medical finding that in the opinion of the Investigator is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data.
  • Any suicidal ideation, including grade 4 or 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) in the past 12 months (i.e., active suicidal thought with intent but without specific plan), or active suicidal thought with plan and intent in the past.
  • Unwillingness to adhere to the rules of UV-light protection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835481


Contacts
Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Sponsors and Collaborators
Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03835481     History of Changes
Other Study ID Numbers: 1407-0005
2018-003487-31 ( EudraCT Number )
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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).

Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases