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

Completed · Phase 2 · Has a placebo group

Conditions studied: Psoriasis

In brief

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

Key facts

Study ID

NCT03635099

Run by

Boehringer Ingelheim

People needed

274

Starts

2018-09-17

Expected to finish

2021-05-26

Last updated by the study team

2022-08-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Total Skin and Beauty Dermatology Center, PC — Birmingham, Alabama, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Southern California Dermatology Inc. — Santa Ana, California, United States
• Hamilton Research — Alpharetta, Georgia, United States
• Advanced Medical Research PC — Sandy Springs, Georgia, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• The Psoriasis Treatment Center of Central New Jersey — East Windsor, New Jersey, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Synexus — Cincinnati, Ohio, United States
• Clinical Partners, LLC — Johnston, Rhode Island, United States
• Clinical Research Center of the Carolinas — Charleston, South Carolina, United States
• Health Concepts — Rapid City, South Dakota, United States
• Menter Dermatology Research Institute — Dallas, Texas, United States
• Center for Clinical Studies — Houston, Texas, United States
• Center for Clinical Studies — Webster, Texas, United States
• Virginia Clinical Research, Inc. — Norfolk, Virginia, United States
• Dr Chih-ho Hong Medical Inc — Surrey, British Columbia, Canada
• Enverus Medical Research — Surrey, British Columbia, Canada
• Dr. Irina Turchin PC Inc. — Fredericton, New Brunswick, Canada
• The Guenther Dermatology Research Centre — London, Ontario, Canada
• DermEdge Research Inc. — Mississauga, Ontario, Canada
• North Bay Dermatology Centre — North Bay, Ontario, Canada
• The Centre for Clinical Trials — Oakville, Ontario, Canada
• SKiN Centre for Dermatology — Peterborough, Ontario, Canada
• The Centre for Dermatology — Richmond Hill, Ontario, Canada

Full record on ClinicalTrials.gov

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