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BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02054481
Recruitment Status : Completed
First Posted : February 4, 2014
Results First Posted : September 19, 2016
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE February 3, 2014
First Posted Date  ICMJE February 4, 2014
Results First Submitted Date  ICMJE July 29, 2016
Results First Posted Date  ICMJE September 19, 2016
Last Update Posted Date September 19, 2016
Study Start Date  ICMJE February 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2016)
Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12 [ Time Frame: Baseline and Week 12 ]
Percentage of participants who achieved ≥90% reduction from baseline in Psoriasis Area and Severity Index score (PASI90) at Week 12. PASI score ranges from 0 (best) to 72 (worst).
Original Primary Outcome Measures  ICMJE
 (submitted: February 3, 2014)
Achievement of >/= 90% reduction from baseline PASI score (PASI90) at week 12 [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2016)
  • Achievement of ≥75% Reduction From Baseline in PASI Score (PASI75) at Weeks 12 and 24 [ Time Frame: Baseline, Week 12 and Week 24 ]
    Percentage of participants who achieved ≥75% reduction from baseline in Psoriasis Area and Severity Index score (PASI75) at Weeks 12 and 24. PASI score ranges from 0 (best) to 72 (worst).
  • Achievement of 100% Reduction From Baseline in PASI Score (PASI100) at Week 12 [ Time Frame: Baseline and Week 12 ]
    Percentage of participants who achieved 100% reduction from baseline in Psoriasis Area and Severity Index score (PASI100) at Week 12. PASI score ranges from 0 (best) to 72 (worst).
  • Achievement of ≥50% Reduction From Baseline in PASI Score (PASI50) at Week 12 [ Time Frame: Baseline and Week 12 ]
    Percentage of participants who achieved ≥50% reduction from baseline in Psoriasis Area and Severity Index score (PASI50) at Week 12. PASI score ranges from 0 (best) to 72 (worst).
  • Achievement of PASI90 at Week 24 [ Time Frame: Week 24 ]
    Percentage of participants who achieved PASI90 at Week 24. PASI score ranges from 0 (best) to 72 (worst).
  • Percentage Change in PASI Score From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ]
    Percentage change in Psoriasis Area and Severity Index (PASI) from baseline at Week 12. PASI score ranges from 0 (best) to 72 (worst).
  • Achievement of sPGA Clear or Almost Clear at Week 12 [ Time Frame: Week 12 ]
    Percentage of participants who achieved static Physician Global Assessment (sPGA) clear or almost clear at Week 12. sPGA is assessed on a six-point scale from 0 (clear) to 5 (severe).
  • Time to Loss of PASI50 Response [ Time Frame: From first drug administration until end of follow-up period, up to 48 weeks ]
    Time to loss of PASI50 response.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2014)
  • Achievement of >/= 50% reduction from baseline in PASI score (PASI50) at week 12 [ Time Frame: 12 weeks ]
  • Achievement of PASI90 at week 24 [ Time Frame: 24 weeks ]
  • Achievement of sPGA clear or almost clear at week 12 [ Time Frame: 12 weeks ]
  • Achievement of >/=75% reduction from baseline in PASI score (PASI75) at week 12 and 24 [ Time Frame: 24 weeks ]
  • Achievement of 100% reduction from baseline in PASI score (PASI100) at week 12 [ Time Frame: 12 weeks ]
  • Percentage of PASI reduction from baseline at week 12 [ Time Frame: 12 weeks ]
  • 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 [ Time Frame: up to 48 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: BI 655066
    Medium dose
  • Drug: BI 655066
    High dose
  • Drug: Ustekinumab
  • Drug: BI 655066
    Low dose
Study Arms  ICMJE
  • Experimental: Arm 1
    BI 655066 s.c.
    Intervention: Drug: BI 655066
  • Experimental: Arm 2
    BI 655066 s.c.
    Intervention: Drug: BI 655066
  • Experimental: Arm 3
    BI 655066 s.c.
    Intervention: Drug: BI 655066
  • Active Comparator: Arm 4
    Ustekinumab s.c.
    Intervention: Drug: Ustekinumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2014)
166
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2014)
160
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Finland,   France,   Germany,   Norway,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02054481
Other Study ID Numbers  ICMJE 1311.2
2012-004384-48 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP