Overview

This trial is active, not recruiting.

Condition psoriasis
Treatments abbv-066, ustekinumab, placebo for abbv-066, placebo for ustekinumab
Phase phase 3
Target IL-12
Sponsor AbbVie
Collaborator Boehringer Ingelheim
Start date February 2016
End date November 2016
Trial size 500 participants
Trial identifier NCT02684357, 1311.28, 2015-003622-13, M15-995

Summary

This is a randomized double blind, double dummy, placebo and active comparator controlled, parallel design study that is being performed to assess the safety and efficacy of BI 655066 to support registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients.

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 (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
abbv-066 BI 655066
placebo for ustekinumab
(Active Comparator)
ustekinumab
placebo for abbv-066
(Placebo Comparator)
placebo for abbv-066
placebo for ustekinumab

Primary Outcomes

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

Secondary Outcomes

Measure
Achievement of a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16
time frame: week 16
Achievement of >= 75% reduction from baseline Psoriasis Area and Severity Index score (PASI 75) at Week 16
time frame: week 16
Achievement of a static Physician Global Assessment (sPGA) score of clear or almost clear at Week 52
time frame: week 52
Achievement of Psoriasis Area and Severity Index score 75% (PASI 75) at Week 52
time frame: week 52
Achievement of >= 75% reduction from baseline Psoriasis Area and Severity Index score (PASI 75) at Week 12
time frame: week 12
Achievement of a static Physician Global Assessment (sPGA) score of clear or almost clear at Week 12
time frame: week 12
Achievement of 100% reduction from baseline Psoriasis Area and Severity Index score (PASI 100) at Week 16
time frame: week 16
Achievement of >= 90% reduction from baseline Psoriasis Area and Severity Index score (PASI 90) at Week 52
time frame: week 52
Achievement of 100% reduction from baseline Psoriasis Area and Severity Index score (PASI 100) at Week 52
time frame: week 52
Change from baseline in psoriasis symptoms evaluated using the total score on the Psoriasis Symptom Diary (PSS) at week 16
time frame: week 16
Achievement of total score on the Psoriasis Symptom Diary (PSS) of 0 at week 16
time frame: week 16

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: - Male or female patients. Women of childbearing potential* must be ready and able to use highly effective methods of birth control per ICH M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. *Women of childbearing potential are defined as: - having experienced menarche and are - not postmenopausal (12 months with no menses without an alternative medical cause) and are - not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy). - Age >= 18 years at screening - Have a 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, - Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization): 1. Have an involved body surface area (BSA) >= 10% and 2. Have a Psoriasis Area and Severity Index (PASI) score >= 12 and 3. Have a static Physician Global Assessment (sPGA) score of >= 3. - Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator - Must be a candidate for treatment with Stelara® (ustekinumab) according to local label. - Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation Exclusion criteria: - Patients with: 1. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular), 2. current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium), 3. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigator's judgment, - Previous exposure to BI 655066, - Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study (participation in observational studies is permitted), - Previous exposure to ustekinumab (Stelara®), - Use of any restricted medication, 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, aneurysm removal, stomach ligation), - Known chronic or relevant acute infections including active tuberculosis, HIV or viral hepatitis; QuantiFERON® TB test or PPD skin test will be performed according to local labelling for comparator products. If the result is positive, patients may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment should have been initiated and maintained according to local country guidelines, - Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix, - Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) 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 is 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, - History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients, - Women who is pregnant, nursing, or who plans to become pregnant while in the trial, - Previous enrolment in this trial.

Additional Information

Official title BI 655066 Versus Ustekinumab and Placebo Comparators in a Randomized Double Blind trIal for Maintenance Use in Moderate to Severe Plaque Type Psoriasis-2 (UltIMMa-2)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AbbVie.