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BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02054481
First Posted: February 4, 2014
Last Update Posted: September 19, 2016
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.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
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.

Condition Intervention Phase
Psoriasis Drug: BI 655066 Drug: Ustekinumab Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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).



Secondary Outcome Measures:
  • 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.


Enrollment: 166
Study Start Date: February 2014
Study Completion Date: July 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
BI 655066 s.c.
Drug: BI 655066
Low dose
Experimental: Arm 2
BI 655066 s.c.
Drug: BI 655066
Medium dose
Experimental: Arm 3
BI 655066 s.c.
Drug: BI 655066
High dose
Active Comparator: Arm 4
Ustekinumab s.c.
Drug: Ustekinumab

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054481


  Show 32 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02054481     History of Changes
Other Study ID Numbers: 1311.2
2012-004384-48 ( EudraCT Number: EudraCT )
First Submitted: February 3, 2014
First Posted: February 4, 2014
Results First Submitted: July 29, 2016
Results First Posted: September 19, 2016
Last Update Posted: September 19, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ustekinumab
Dermatologic Agents