This Study is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI 730357 and How Effective it is

Study Purpose

The primary objective is based on Week 12 co-primary endpoints of PASI (Psoriasis Area and Severity Index) 75 and sPGA (Static Physician's Global Assessment) 0/1, and overall safety Secondary objectives of Part 1 are to evaluate the efficacy and safety of BI 730357 through 24 weeks of treatment

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 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male or female patients.
Woman Of Childbearing 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.
  • - Age 18 to 75 years (both inclusive) at screening - BMI < 35 kg/m2 at screening - Diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug.
Duration of diagnosis may be reported by the patient
  • - Patients must be candidates for systemic PsO therapy.
Moderate-to-severe plaque psoriasis:
  • - BSA ≥10% and - PASI ≥12 and - sPGA moderate or severe - 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 or previous exposure to BI 730357.
  • - Current enrollment in another investigational device or drug trial, or is less than 30 days (from randomisation) since ending another investigational device or drug trial(s), or receipt of other investigational treatment(s).
  • - Use of - any biologic agent within 12 weeks, or - any anti IL-23 biologic agent within 24 weeks prior to randomisation, or - systemic anti-psoriatic medications or phototherapy within 4 weeks prior to randomisation, or - topical anti-psoriasis medications within 2 weeks prior to randomisation - Receipt of a live vaccination within 12 weeks prior to randomisation (visit 2), or any plan to receive a live vaccination during the conduct of this trial - Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe 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.
  • - Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomisation or planned within 12 months after screening, e.g., hip replacement - Women who are pregnant, nursing, or who plan to become pregnant while in the trial - Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, 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.
A patient can be re-screened if the patient was treated and is cured from the acute infection.
  • - Evidence of a current or previous disease (including known or suspected IBD, and 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 (CSSRS) in the past 3 months (i.e., active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).
- Unwillingness to adhere to the rules of UV-light protection - Further exclusion criteria apply

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.

NCT03635099
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 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

Experimental: Dose group A

Experimental: Dose group B

Experimental: Dose group C

Experimental: Dose group D

Placebo Comparator: Placebo

Experimental: Dose group V

Experimental: Dose group U

Placebo Comparator: Placebo W

Interventions

Drug: - BI 730357

Film-coated tablet

Drug: - Placebo

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

Recruiting

Address

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, 35205

Site Contact

James Krell

[email protected]

+001 (205) 933-0987

Dermatology Research Associates, Los Angeles, California

Status

Recruiting

Address

Dermatology Research Associates

Los Angeles, California, 90045

Site Contact

Howard Sofen

[email protected]

+001 (310) 337-7171

Southern California Dermatology Inc., Santa Ana, California

Status

Recruiting

Address

Southern California Dermatology Inc.

Santa Ana, California, 92701

Site Contact

Jennifer Soung

[email protected]

+001 (714) 547-5151

Hamilton Research, Alpharetta, Georgia

Status

Recruiting

Address

Hamilton Research

Alpharetta, Georgia, 30022

Site Contact

Tiffani Hamilton

[email protected]

+001 (770) 360-8881

Advanced Medical Research PC, Sandy Springs, Georgia

Status

Recruiting

Address

Advanced Medical Research PC

Sandy Springs, Georgia, 30328

Site Contact

Jamie Weisman

[email protected]

+001 (404) 939-9220

Indianapolis, Indiana

Status

Recruiting

Address

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250

Site Contact

Scott Fretzin

[email protected]

+001 (317) 516-5030-x102

East Windsor, New Jersey

Status

Recruiting

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

Completed

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10003

Synexus, Cincinnati, Ohio

Status

Completed

Address

Synexus

Cincinnati, Ohio, 45236

Clinical Partners, LLC, Johnston, Rhode Island

Status

Recruiting

Address

Clinical Partners, LLC

Johnston, Rhode Island, 02919

Site Contact

Ellen Frankel

[email protected]

+001 (401) 454-3800

Charleston, South Carolina

Status

Recruiting

Address

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407

Site Contact

Todd Schlesinger

[email protected]

+001 (843) 556-8886

Health Concepts, Rapid City, South Dakota

Status

Recruiting

Address

Health Concepts

Rapid City, South Dakota, 57702

Site Contact

Richard Beasley

[email protected]

+001 (605) 721-5094

Menter Dermatology Research Institute, Dallas, Texas

Status

Recruiting

Address

Menter Dermatology Research Institute

Dallas, Texas, 75246

Site Contact

Martin Menter

[email protected]

+001 (972) 354-7993

Center for Clinical Studies, Houston, Texas

Status

Recruiting

Address

Center for Clinical Studies

Houston, Texas, 77004

Site Contact

Stephen Tyring

[email protected]

+001 (281) 333-2288

Center for Clinical Studies, Webster, Texas

Status

Recruiting

Address

Center for Clinical Studies

Webster, Texas, 77598

Site Contact

Patricia Lee

[email protected]

+001 (281) 333-2288-x2

Virginia Clinical Research, Inc., Norfolk, Virginia

Status

Recruiting

Address

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502

Site Contact

David Pariser

[email protected]

+001 (757) 625-0151

International Sites

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

Status

Recruiting

Address

Dr Chih-ho Hong Medical Inc

Surrey, British Columbia, V3R 6A7

Site Contact

Chih-ho Hong

[email protected]

604-953-1333 ext. 1

Enverus Medical Research, Surrey, British Columbia, Canada

Status

Completed

Address

Enverus Medical Research

Surrey, British Columbia, V3V 0C6

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

Status

Recruiting

Address

Dr. Irina Turchin PC Inc.

Fredericton, New Brunswick, E3B 1G9

Site Contact

Irina Turchin

[email protected]

506-459-1808

The Guenther Dermatology Research Centre, London, Ontario, Canada

Status

Completed

Address

The Guenther Dermatology Research Centre

London, Ontario, N6A 3H7

DermEdge Research Inc., Mississauga, Ontario, Canada

Status

Recruiting

Address

DermEdge Research Inc.

Mississauga, Ontario, L5H 1G9

Site Contact

Mark Lomaga

[email protected]

905-274-9996

North Bay Dermatology Centre, North Bay, Ontario, Canada

Status

Completed

Address

North Bay Dermatology Centre

North Bay, Ontario, P1B 3Z7

The Centre for Clinical Trials, Oakville, Ontario, Canada

Status

Recruiting

Address

The Centre for Clinical Trials

Oakville, Ontario, L6J 7W5

Site Contact

Sheetal Sapra

[email protected]

905-842-2262

SKiN Centre for Dermatology, Peterborough, Ontario, Canada

Status

Recruiting

Address

SKiN Centre for Dermatology

Peterborough, Ontario, K9J 5K2

Site Contact

Melinda Gooderham

[email protected]

(705) 775-7546

The Centre for Dermatology, Richmond Hill, Ontario, Canada

Status

Recruiting

Address

The Centre for Dermatology

Richmond Hill, Ontario, L4B 1A5

Site Contact

Mani Raman

[email protected]

905-889-2019

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

Status

Recruiting

Address

K. Papp Clinical Research Inc.

Waterloo, Ontario, N2J 1C4

Site Contact

Kim Papp

[email protected]

519-579-9535

XLR8 Medical Research Inc., Windsor, Ontario, Canada

Status

Recruiting

Address

XLR8 Medical Research Inc.

Windsor, Ontario, N8W 1E6

Site Contact

Darryl Toth

[email protected]

519-971-9700

Charité - Universitätsmedizin Berlin, Berlin, Germany

Status

Completed

Address

Charité - Universitätsmedizin Berlin

Berlin, , 10117

Studienzentrum im Jahrhunderthaus, Bochum, Germany

Status

Completed

Address

Studienzentrum im Jahrhunderthaus

Bochum, , 44793

Universitätsklinikum Frankfurt, Frankfurt am Main, Germany

Status

Completed

Address

Universitätsklinikum Frankfurt

Frankfurt am Main, , 60596

TFS Trial Form Support GmbH, Hamburg, Germany

Status

Completed

Address

TFS Trial Form Support GmbH

Hamburg, , 20537

Universitätsklinikum Heidelberg, Heidelberg, Germany

Status

Completed

Address

Universitätsklinikum Heidelberg

Heidelberg, , 69120

Lübeck, Germany

Status

Completed

Address

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, , 23538

Universitätsklinikum Münster, Münster, Germany

Status

Completed

Address

Universitätsklinikum Münster

Münster, , 48149

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