Clinical trial NCT03635099: This Study is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI 730357 and How Effective it is
Official title: Phase II Evaluation of Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2018-08-17
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Week 12
timeFrame: Assesment at week 12 of treatment
measure: Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' or 'Almost Clear' (sPGA 0/1) at Week 12.
timeFrame: Assesment at week 12 of treatment
Secondary outcomes:
measure: Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 50 at Week 12
timeFrame: Assesment at week 12 of treatment
measure: Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 90 at Week 12
timeFrame: Assesment at week 12 of treatment
measure: Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 100 at Week 12
timeFrame: Assesment at week 12 of treatment
measure: Number of Patients Who Achieved Psoriasis Area Severity Index Score (PASI) 75 at Weeks 16, 20, and 24
timeFrame: Assesment at week 16, 20 and 24 of treatment
measure: Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' (sPGA 0) at Week 12
timeFrame: Assesment at week 12 of treatment
measure: Number of Patients Who Achieved a Static Physician's Global Assessment Score of 'Clear' or 'Almost Clear' (sPGA 0/1) at Weeks 16, 20, and 24
timeFrame: Assesment at week 16, 20 and 24 of treatment
measure: Overall Change From Baseline in Psoriasis Symptoms Evaluated Using the Total Score of the Psoriasis Symptoms Scale (PSS) at Week 12
timeFrame: Assesment at week 12 of treatment
measure: Number of Patients Who Achieved a Dermatology Life Quality Index Score of 'no Effect on Patient's Life' (DLQI 0/1) at Week 12
timeFrame: Assesment at week 12 of treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center, PC
state: Alabama
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology Inc.
state: California
city: Alpharetta
country: United States
facility: Hamilton Research
state: Georgia
city: Sandy Springs
country: United States
facility: Advanced Medical Research PC
state: Georgia
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: East Windsor
country: United States
facility: The Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cincinnati
country: United States
facility: Synexus
state: Ohio
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Dallas
country: United States
facility: Menter Dermatology Research Institute
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Surrey
country: Canada
facility: Dr Chih-ho Hong Medical Inc
state: British Columbia
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Fredericton
country: Canada
facility: Dr. Irina Turchin PC Inc.
state: New Brunswick
city: London
country: Canada
facility: The Guenther Dermatology Research Centre
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research Inc.
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Oakville
country: Canada
facility: The Centre for Clinical Trials
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research Inc.
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research Inc.
state: Ontario
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Bochum
country: Germany
facility: Studienzentrum im Jahrhunderthaus
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Hamburg
country: Germany
facility: TFS Trial Form Support GmbH
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck
city: Münster
country: Germany
facility: Universitätsklinikum Münster
Study officials:
References: