BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab

Psoriasis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02054481
• Other study ID #: 1311.2
• Secondary ID: 2012-004384-48
• Status: Completed
• Phase: Phase 2
• First received: February 3, 2014
• Last updated: August 12, 2015
• Start date: February 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaFinland: Finnish Medicines AgencyFrance: Agence Nationale de Sécurité du Médicament et des produits de santéGermany: Paul-Ehrlich-InstitutNorway: Norwegian Medicines AgencySweden: Medical Products AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: July 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• BI 655066
Medium dose
• BI 655066
High dose
• Ustekinumab

• BI 655066
Low dose

Locations

Country	Name	City	State
Canada	1311.2.20002 Boehringer Ingelheim Investigational Site	Markham	Ontario
Canada	1311.2.20005 Boehringer Ingelheim Investigational Site	Peterborough	Ontario
Canada	1311.2.20004 Boehringer Ingelheim Investigational Site	Sainte-Foy	Quebec
Canada	1311.2.20003 Boehringer Ingelheim Investigational Site	Waterloo	Ontario
Finland	1311.2.35802 Boehringer Ingelheim Investigational Site	Helsinki
Finland	1311.2.35801 Boehringer Ingelheim Investigational Site	Turku
France	1311.2.33005 Boehringer Ingelheim Investigational Site	Marseille
France	1311.2.33002 Boehringer Ingelheim Investigational Site	Nice
France	1311.2.33001 Boehringer Ingelheim Investigational Site	Paris
France	1311.2.33004 Boehringer Ingelheim Investigational Site	Pessac
France	1311.2.33003 Boehringer Ingelheim Investigational Site	Rouen
France	1311.2.33006 Boehringer Ingelheim Investigational Site	Toulouse
Germany	1311.2.49001 Boehringer Ingelheim Investigational Site	Berlin
Germany	1311.2.49003 Boehringer Ingelheim Investigational Site	Dresden
Germany	1311.2.49005 Boehringer Ingelheim Investigational Site	Lübeck
Germany	1311.2.49002 Boehringer Ingelheim Investigational Site	Mainz
Germany	1311.2.49004 Boehringer Ingelheim Investigational Site	Münster
Norway	1311.2.47002 Boehringer Ingelheim Investigational Site	Ålesund
Norway	1311.2.47001 Boehringer Ingelheim Investigational Site	Oslo
Sweden	1311.2.46001 Boehringer Ingelheim Investigational Site	Stockholm
United States	1311.2.10003 Boehringer Ingelheim Investigational Site	Arlington Hts	Illinois
United States	1311.2.10002 Boehringer Ingelheim Investigational Site	Bay City	Michigan
United States	1311.2.10006 Boehringer Ingelheim Investigational Site	Dallas	Texas
United States	1311.2.10001 Boehringer Ingelheim Investigational Site	East Windsor	New Jersey
United States	1311.2.10004 Boehringer Ingelheim Investigational Site	Fridley	Minnesota
United States	1311.2.10011 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	1311.2.10010 Boehringer Ingelheim Investigational Site	Los Angeles	California
United States	1311.2.10013 Boehringer Ingelheim Investigational Site	Port Orange	Florida
United States	1311.2.10005 Boehringer Ingelheim Investigational Site	Portland	Oregon
United States	1311.2.10007 Boehringer Ingelheim Investigational Site	Raleigh	North Carolina
United States	1311.2.10012 Boehringer Ingelheim Investigational Site	Spokane	Washington
United States	1311.2.10009 Boehringer Ingelheim Investigational Site	Verona	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Canada,  Finland,  France,  Germany,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of >/= 90% reduction from baseline PASI score (PASI90) at week 12		12 weeks	No
Secondary	Achievement of >/= 50% reduction from baseline in PASI score (PASI50) at week 12		12 weeks	No
Secondary	Achievement of PASI90 at week 24		24 weeks	No
Secondary	Achievement of sPGA clear or almost clear at week 12		12 weeks	No
Secondary	Achievement of >/=75% reduction from baseline in PASI score (PASI75) at week 12 and 24		24 weeks	No
Secondary	Achievement of 100% reduction from baseline in PASI score (PASI100) at week 12		12 weeks	No
Secondary	Percentage of PASI reduction from baseline at week 12		12 weeks	No
Secondary	Time to loss of PASI50 response. This endpoint is calculated from the first treatment to first < 50% reduction of PASI score compared with baseline after the response has been achieved		up to 48 weeks	No