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



Status:Not yet recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:Any
Updated:2/17/2019
Start Date:March 18, 2019
End Date:April 10, 2025
Contact:Boehringer Ingelheim
Email:clintriage.rdg@boehringer-ingelheim.com
Phone:1-800-243-0127

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Phase II Long-term Extension Study to Assess the Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis

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


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
We found this trial at
17
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Birmingham, Alabama 35205
Phone: +001 (205) 933-0987
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59 One Mile Road
East Windsor, New Jersey 08520
609-443-4500
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Alpharetta, Georgia 30022
Phone: +001 (770) 360-8881
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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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Dallas, Texas 75246
Phone: +001 (972) 354-7993
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Houston, Texas 77030
Phone: +001 (281) 333-2288
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Indianapolis, Indiana 46256
Phone: +001 (317) 516-5030-x102
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Johnston, Rhode Island 02919
Phone: +001 (401) 454-3800
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Los Angeles, California 90045
Phone: +001 (310) 337-7171
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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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Rapid City, South Dakota 57702
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Sandy Springs, Georgia 30328
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Santa Ana, California 92701
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Surrey, British Columbia
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Webster, Texas 77598
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