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



Status:Recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 75
Updated:4/6/2019
Start Date:September 17, 2018
End Date:November 11, 2019
Contact:Boehringer Ingelheim
Email:clintriage.rdg@boehringer-ingelheim.com
Phone:1-800-243-0127

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Phase II Evaluation of Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis

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 are to evaluate the safety of BI 730357 through 24 weeks of treatment,
and the effects of dose escalation and longer treatment duration on efficacy


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.

- Currently enrolled 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 is receiving 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

- Received 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,
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
We found this trial at
16
sites
Houston, Texas 77030
Phone: +001 (281) 333-2288
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59 One Mile Road
East Windsor, New Jersey 08520
609-443-4500
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East Windsor, NJ
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Alpharetta, Georgia 30022
Phone: +001 (770) 360-8881
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Alpharetta, GA
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Birmingham, Alabama 35205
Phone: +001 (205) 933-0987
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Birmingham, AL
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Charleston, South Carolina 29414
Phone: +001 (843) 556-8886
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Cincinnati, Ohio 45236
Phone: +001 (513) 247-5577
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Cincinnati, OH
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Dallas, Texas 75246
Phone: +001 (972) 354-7993
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Dallas, TX
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Indianapolis, Indiana 46256
Phone: +001 (317) 516-5030-x102
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Indianapolis, IN
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Johnston, Rhode Island 02919
Phone: +001 (401) 454-3800
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Johnston, RI
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Los Angeles, California 90045
Phone: +001 (310) 337-7171
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Los Angeles, CA
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Phone: +001 (212) 844-3288
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Norfolk, Virginia 23507
Phone: +001 (757) 625-0151
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Norfolk, VA
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Rapid City, South Dakota 57702
Phone: +001 (605) 721-5094
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Santa Ana, California 92701
Phone: +001 (714) 547-5151
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Surrey, British Columbia
Phone: 604-953-1333 ext. 1
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Surrey,
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Webster, Texas 77598
Phone: +001 (281) 333-2288-x2
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Webster, TX
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