Clinical trial NCT02054481: BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab
Official title: A 48 Weeks Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque Psoriasis (Randomised, Dose-ranging, Active-comparator-controlled (Ustekinumab), Double-blind Within Dose Groups of BI 655066)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-02-04
Enrollment: 166
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 overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to select doses for further clinical trials.


Eligibility criteria: Inclusion criteria:

* Body Mass Index (BMI) \>/= 18.5 and \< 40 kg/m²
* Patients with stable moderate to severe chronic plaque-type psoriasis with or without psoriatic arthritis involving \>/= 10% body surface area, with disease severity PASI \>/= 12 and sPGA score of moderate and above (score of at least 3) at screening visit and visit 2 (randomisation), as assessed by the investigator
* Psoriasis disease duration of at least 6 months prior to screening, as assessed by the investigator
* Patients must be candidates for systemic psoriasis treatment or phototherapy, as assessed by the investigator
* Patients must be suitable candidates for ustekinumab (Stelara®) therapy as given in the local labelling
* Patient must give informed consent and sign an approved consent form prior to any study procedures in accordance with GCP and local legislation

Exclusion criteria:

* Patients with guttate, erythrodermic, or pustular psoriasis and patients with drug-induced psoriasis, as diagnosed by the investigator
* Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding of the medical examination (including vital signs and ECG), that in the opinion of the investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied. (Psoriatic arthritis is not considered an exclusion criterion)
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders, or history of orthostatic hypotension, fainting spells or blackouts, that in the investigator's judgement, could jeopardize the safe conduct of the study.
* Clinically important acute or chronic infections including hepatitis and HIV.

With regards to tuberculosis the following applies:

Have signs or symptoms suggestive of current active or latent TB upon medical history, physical examination and/or a chest radiograph (both posterior-anterior and lateral views, taken within 3 months prior to the first administration of study drug and read by a qualified radiologist).

Have history of latent or active TB prior to screening, except for patients who have documentation of having completed an adequate treatment regimen at least 6 months prior to the first administration of study agent.

Have positive IGRA testing (QuantiFERON-TB Gold) within 2 months prior to or during screening, in which active TB has not been ruled out, except for patients with history of latent TB and documentation of having completed an adequate treatment regimen at least 6 months prior to the first administration of study agent.

* Have had a live vaccination \</= 12 weeks prior to randomisation (visit 2). Patients must agree not to receive a live vaccination during the study. No BCG vaccines should be given for one year prior to randomisation (visit 2), during the study and for one year after last administration of study drug (according to the Stelara® SPC).
* History of clinically significant hypersensitivity to a systemically administered biologic agent or its excipients
* History of malignancy in the past 5 years or suspicion of active malignant disease except treated cutaneous squamous cell or basal cell carcinoma
* Has received any therapeutic agent directly targeted to IL-12, IL-23 (including ustekinumab (Stelara®))
* Use of biologic agents within 12 weeks (infliximab, etanercept, adalimumab, other biologics) prior to treatment, systemic anti-psoriatic medications or phototherapy within 4 weeks prior to treatment, or topical anti-psoriasis medications within 2 weeks prior to treatment

Primary outcomes:
measure: Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Achievement of ≥75% Reduction From Baseline in PASI Score (PASI75) at Weeks 12 and 24
timeFrame: Baseline, Week 12 and Week 24
measure: Achievement of 100% Reduction From Baseline in PASI Score (PASI100) at Week 12
timeFrame: Baseline and Week 12
measure: Achievement of ≥50% Reduction From Baseline in PASI Score (PASI50) at Week 12
timeFrame: Baseline and Week 12
measure: Achievement of PASI90 at Week 24
timeFrame: Week 24
measure: Percentage Change in PASI Score From Baseline at Week 12
timeFrame: Baseline and Week 12
measure: Achievement of sPGA Clear or Almost Clear at Week 12
timeFrame: Week 12
measure: Time to Loss of PASI50 Response
timeFrame: From first drug administration until end of follow-up period, up to 48 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: 1311.2.10010 Boehringer Ingelheim Investigational Site
state: California
city: Port Orange
country: United States
facility: 1311.2.10013 Boehringer Ingelheim Investigational Site
state: Florida
city: Arlington Hts
country: United States
facility: 1311.2.10003 Boehringer Ingelheim Investigational Site
state: Illinois
city: Bay City
country: United States
facility: 1311.2.10002 Boehringer Ingelheim Investigational Site
state: Michigan
city: Fridley
country: United States
facility: 1311.2.10004 Boehringer Ingelheim Investigational Site
state: Minnesota
city: East Windsor
country: United States
facility: 1311.2.10001 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Verona
country: United States
facility: 1311.2.10009 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Raleigh
country: United States
facility: 1311.2.10007 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Portland
country: United States
facility: 1311.2.10005 Boehringer Ingelheim Investigational Site
state: Oregon
city: Dallas
country: United States
facility: 1311.2.10006 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1311.2.10011 Boehringer Ingelheim Investigational Site
state: Texas
city: Spokane
country: United States
facility: 1311.2.10012 Boehringer Ingelheim Investigational Site
state: Washington
city: Markham
country: Canada
facility: 1311.2.20002 Boehringer Ingelheim Investigational Site
state: Ontario
city: Peterborough
country: Canada
facility: 1311.2.20005 Boehringer Ingelheim Investigational Site
state: Ontario
city: Waterloo
country: Canada
facility: 1311.2.20003 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sainte-Foy
country: Canada
facility: 1311.2.20004 Boehringer Ingelheim Investigational Site
state: Quebec
city: Helsinki
country: Finland
facility: 1311.2.35802 Boehringer Ingelheim Investigational Site
city: Turku
country: Finland
facility: 1311.2.35801 Boehringer Ingelheim Investigational Site
city: Marseille
country: France
facility: 1311.2.33005 Boehringer Ingelheim Investigational Site
city: Nice
country: France
facility: 1311.2.33002 Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1311.2.33001 Boehringer Ingelheim Investigational Site
city: Pessac
country: France
facility: 1311.2.33004 Boehringer Ingelheim Investigational Site
city: Rouen
country: France
facility: 1311.2.33003 Boehringer Ingelheim Investigational Site
city: Toulouse
country: France
facility: 1311.2.33006 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1311.2.49001 Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 1311.2.49003 Boehringer Ingelheim Investigational Site
city: Lübeck
country: Germany
facility: 1311.2.49005 Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: 1311.2.49002 Boehringer Ingelheim Investigational Site
city: Münster
country: Germany
facility: 1311.2.49004 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1311.2.47001 Boehringer Ingelheim Investigational Site
city: Ålesund
country: Norway
facility: 1311.2.47002 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1311.2.46001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Suleiman AA, Khatri A, Oberoi RK, Othman AA. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis. Clin Pharmacokinet. 2020 May;59(5):575-589. doi: 10.1007/s40262-019-00829-2.
citation: Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. Clin Pharmacokinet. 2019 Oct;58(10):1309-1321. doi: 10.1007/s40262-019-00759-z.
citation: Papp KA, Blauvelt A, Bukhalo M, Gooderham M, Krueger JG, Lacour JP, Menter A, Philipp S, Sofen H, Tyring S, Berner BR, Visvanathan S, Pamulapati C, Bennett N, Flack M, Scholl P, Padula SJ. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20;376(16):1551-1560. doi: 10.1056/NEJMoa1607017.