Clinical trial NCT03835481: A Study to Test How Well Patients With Plaque Psoriasis Tolerate BI 730357 Over a Longer Period and How Effective it is
Official title: Phase II Long-term Extension Study to Assess the Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-02-08
Enrollment: 165
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Woman Of Child Bearing 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.
* Patients with moderate-to-severe plaque Psoriasis (PsO) who have completed treatment in the preceding trial without early discontinuation, agree to continue treatment in 1407-0005, and

  * for patients entering from Part 1 of trial 1407-0030

    --- achieve a ≥PASI50 response upon completing the trial 1407-0030 Week 24 end-of-treatment visit
  * for patients entering from Part 2 of trial 1407-0030 --- achieve a ≥PASI50 response upon completing the trial 1407-0030 Week 12 end-of-treatment visit or perceived patient improvement, at the discretion of the Investigator
* 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 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
* Ongoing AEs consistent with intolerance of trial medication (including gastric intolerance) from 1407-0030, that in the opinion of the investigator would compromise the safety of the patient.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: For part 1 patients in period 1: Up to 117 days. For part 1 patients in period 2: From week 13 onwards, up to 692 days. For part 2 patients (period 1 + 2): Up to 802 days.
Secondary outcomes:
measure: Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24
timeFrame: At baseline and at week 24.
measure: Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24
timeFrame: At week 24.
measure: Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24
timeFrame: At week 24.
measure: Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response
timeFrame: Up to 802 days.
measure: Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response
timeFrame: Up to 802 days.
measure: Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response
timeFrame: Up to 802 days.
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: 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: 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: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Hamburg
country: Germany
facility: TFS Trial Form Support GmbH
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck
city: Münster
country: Germany
facility: Universitätsklinikum Münster
Study officials:
References: