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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Woman Of Child Bearing Potential (WOCBP) 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 treatment in the preceding trial without early discontinuation, agree to continue treatment in 1407-0005, and.
  • - for patients entering from Part 1 of trial 1407-0030.
--- achieve a ≥PASI50 response upon completing the trial 1407-0030 Week 24 end-of-treatment visit.
  • - for patients entering from Part 2 of trial 1407-0030 --- achieve a ≥PASI50 response upon completing the trial 1407-0030 Week 12 end-of-treatment visit or perceived patient improvement, at the discretion of the Investigator.
  • - 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 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.
  • - Ongoing AEs consistent with intolerance of trial medication (including gastric intolerance) from 1407-0030, that in the opinion of the investigator would compromise the safety of the patient.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03835481
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Canada, Germany, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

Placebo Comparator: Placebo

Blinded period of Placebo until Week 12

Experimental: BI 730357 Fasted Condition

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).

Experimental: BI 730357 Fed Condition

Patients entering extension trial from Part 2 of trial 1407-0030

Interventions

Drug: - BI 730357

Film-coated tablet

Drug: - Placebo to match BI 730357

Film-coated tablet

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Address

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, 35205

Dermatology Research Associates, Los Angeles, California

Status

Address

Dermatology Research Associates

Los Angeles, California, 90045

Southern California Dermatology Inc., Santa Ana, California

Status

Address

Southern California Dermatology Inc.

Santa Ana, California, 92701

Hamilton Research, Alpharetta, Georgia

Status

Address

Hamilton Research

Alpharetta, Georgia, 30022

Advanced Medical Research PC, Sandy Springs, Georgia

Status

Address

Advanced Medical Research PC

Sandy Springs, Georgia, 30328

Indianapolis, Indiana

Status

Address

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250

East Windsor, New Jersey

Status

Address

The Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10003

Clinical Partners, LLC, Johnston, Rhode Island

Status

Address

Clinical Partners, LLC

Johnston, Rhode Island, 02919

Charleston, South Carolina

Status

Address

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407

Health Concepts, Rapid City, South Dakota

Status

Address

Health Concepts

Rapid City, South Dakota, 57702

Menter Dermatology Research Institute, Dallas, Texas

Status

Address

Menter Dermatology Research Institute

Dallas, Texas, 75246

Center for Clinical Studies, Houston, Texas

Status

Address

Center for Clinical Studies

Houston, Texas, 77004

Center for Clinical Studies, Webster, Texas

Status

Address

Center for Clinical Studies

Webster, Texas, 77598

Virginia Clinical Research, Inc., Norfolk, Virginia

Status

Address

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502

International Sites

Dr Chih-ho Hong Medical Inc, Surrey, British Columbia, Canada

Status

Address

Dr Chih-ho Hong Medical Inc

Surrey, British Columbia, V3R 6A7

Enverus Medical Research, Surrey, British Columbia, Canada

Status

Address

Enverus Medical Research

Surrey, British Columbia, V3V 0C6

Dr. Irina Turchin PC Inc., Fredericton, New Brunswick, Canada

Status

Address

Dr. Irina Turchin PC Inc.

Fredericton, New Brunswick, E3B 1G9

The Guenther Dermatology Research Centre, London, Ontario, Canada

Status

Address

The Guenther Dermatology Research Centre

London, Ontario, N6A 3H7

DermEdge Research Inc., Mississauga, Ontario, Canada

Status

Address

DermEdge Research Inc.

Mississauga, Ontario, L5H 1G9

North Bay Dermatology Centre, North Bay, Ontario, Canada

Status

Address

North Bay Dermatology Centre

North Bay, Ontario, P1B 3Z7

The Centre for Clinical Trials, Oakville, Ontario, Canada

Status

Address

The Centre for Clinical Trials

Oakville, Ontario, L6J 7W5

SKiN Centre for Dermatology, Peterborough, Ontario, Canada

Status

Address

SKiN Centre for Dermatology

Peterborough, Ontario, K9J 5K2

K. Papp Clinical Research Inc., Waterloo, Ontario, Canada

Status

Address

K. Papp Clinical Research Inc.

Waterloo, Ontario, N2J 1C4

XLR8 Medical Research Inc., Windsor, Ontario, Canada

Status

Address

XLR8 Medical Research Inc.

Windsor, Ontario, N8W 1E6

Charité - Universitätsmedizin Berlin, Berlin, Germany

Status

Address

Charité - Universitätsmedizin Berlin

Berlin, , 10117

Universitätsklinikum Frankfurt, Frankfurt am Main, Germany

Status

Address

Universitätsklinikum Frankfurt

Frankfurt am Main, , 60596

TFS Trial Form Support GmbH, Hamburg, Germany

Status

Address

TFS Trial Form Support GmbH

Hamburg, , 20537

Lübeck, Germany

Status

Address

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, , 23538

Universitätsklinikum Münster, Münster, Germany

Status

Address

Universitätsklinikum Münster

Münster, , 48149

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