This trial is active, not recruiting.

Condition psoriasis
Treatments bi 655066, placebo
Phase phase 3
Sponsor Boehringer Ingelheim
Start date February 2016
End date November 2016
Trial size 500 participants
Trial identifier NCT02672852, 1311.4, 2014-005102-38


This is a confirmatory, multicentre, randomized, double-blind, placebo controlled, 104 week study with a 88 week treatment period and a 16 week follow-up period evaluating the efficacy and safety of BI 655066 to support Registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients. This study will also look at the maintenance of response following randomly withdrawing treatment from those patients responding to treatment at week 28, as well as the response to re-treatment for patients who relapse. This study will also assess PK and emergence of anti-drug antibodies as well as the influence of study treatment on disease specific markers. In a subset of psoriasis patients with concomitant psoriatic arthritis, the signs and symptoms of psoriatic arthritis will be evaluated to assess improvement.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment
bi 655066
(Placebo Comparator)

Primary Outcomes

Achievement of >= 90% reduction from baseline Psoriasis Area and Severity Index (PASI) score (PASI90) at week 16
time frame: week 16
Achievement of an static Physician Global Assessment (sPGA) score of clear or almost clear at week 16
time frame: Week 16

Secondary Outcomes

Achievement of 100% reduction from baseline PASI score (PASI100) at week 16
time frame: Week 16
Achievement of PASI 90 at Week 52
time frame: Week 52
Achievement of PASI 100 at Week 52
time frame: Week 52
Achievement of a 75% reduction from baseline PASI score (PASI 75) at week 16
time frame: Week 16
Achievement of an sPGA score of clear(0) at Week 16
time frame: Week 16
Achievement of a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16
time frame: Week 16
Achievement of an sPGA score of clear (0) or almost clear (1) at Week 52
time frame: Week 52
Achievement of PASI 75 at Week 52
time frame: Week 52

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: - Male or female patients. Woman of childbearing potential must be ready and willing to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1 percent per year when used consistently and correctly. - Age >=18 years at screening - Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the patient. - Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization); Have an involved body surface area (BSA) >= 10% and Have a Psoriasis Area and Severity Index (PASI) >= 12 and Have a static Physician Global Assessment (sPGA) score of > = 3. - Must be a candidate for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator - Signed and dated written informed consent prior to admission to the study and performance of any study procedures in accordance with GCP and local legislation Exclusion criteria: - Patients with nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular); current drug-induced psoriasis (including a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium); active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to the investigators judgment. - Previous exposure to BI 655066 - Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study - Use of any restricted medication as noted or any drug considered likely to interfere with the safe conduct of the study. - Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g. hip replacement, removal aneurysm, stomach ligation,). - Known chronic or relevant acute infections such as active tuberculosis, HIV, or viral hepatitis - Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix - Evidence of a current or previous disease (including chronic alcohol or drug abuse), medical condition other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and ECG), or laboratory value at the screening visit outside the reference range that in the opinion of the Investigator, is clinically significant and would make the study participant unable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data. - History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients - Women who are pregnant, nursing, or who plan to become pregnant while in the trial - Previous enrolment in this trial

Additional Information

Official title BI 655066 Versus Placebo In a Multicenter Randomized Double-blind Study in Patients With Moderate to Severe Chronic Plaque Psoriasis Evaluating the Efficacy and Safety With Randomized Withdrawal and Re-treatment (IMMhance)
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.