Double-blind, Randomised, Placebo-controlled Trial Investigating BIRT 2584 XX in Patients With Moderate/Severe Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00333411
First received: June 2, 2006
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

The purpose of this clinical study is to determine the effectiveness, pharmacokinetics and safety of several doses of BIRT 2584 XX (100mg, 300mg and 500mg) taken once daily in the treatment of moderate to severe plaque-type psoriasis. This new medicine will be compared to a so-called placebo medicine over 12 weeks with a 12 weeks treatment extension possible.


Condition Intervention Phase
Psoriasis
Drug: BIRT 2584 XX
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 12 Week Double-blind, Randomised, Placebo-controlled, Modified Dose-escalation Trial to Investigate Safety, Efficacy, and Pharmacokinetics of BIRT 2584XX Tablets at Doses of 100, 300 and 500 mg Administered Once Daily in Patients With Moderate to Severe Psoriasis With a 12 Week Treatment Extension

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Achievement of > 75% reduction from baseline in Psoriasis Area and Severity Index (PASI) score (PASI75 ) at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other PASI assessments, NPF Psoriasis Score Static Psoriasis Global Assessment (sPGA), Discontinuations of therapy due to lack of efficacy, Relapse and rebound, Dermatology Life Quality Index, Pain Visual Analog Scale for psoriatic arthritis [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 360
Study Start Date: June 2006
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIRT 2584 XX high dose Drug: BIRT 2584 XX
Experimental: BIRT 2584 XX medium dose Drug: BIRT 2584 XX
Experimental: BIRT 2584 XX low dose Drug: BIRT 2584 XX
Placebo Comparator: Placebo Drug: Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion_Criteria:

  1. Age 18 to 75, males or females
  2. Patients with stable moderate to severe plaque-type psoriasis involving ?10% body surface area, with minimum disease severity PASI ?10 and with static PGA of at least moderate (score of at least 3) at screening visit
  3. Psoriasis disease duration of at least 6 months prior to screening
  4. Patients must be candidates for systemic psoriasis treatment or phototherapy
  5. Patient must give informed consent and sign an approved consent form prior to any study procedures, including wash out of prohibited medications (Patients participating in the PK sub-study will sign an additional consent form. Refusal to participate in the sub-study will not exclude from participation in the main trial)

Exclusion_Criteria:

  1. Patients with primary guttatae, erythrodermic, or pustular psoriasis
  2. Patients who have previously discontinued efalizumab treatment due to lack of efficacy
  3. Patients using treatments that could interfere with the primary endpoint of the study (cf. protocol section 4.2.2.1)
  4. Patients on treatment with warfarin, paracetamol (acetaminophen), some NSAIDs, some antidepressants, medications known to induce or inhibit CYP3A4, or any other concomitant medication where potential drug-drug interactions with BIRT 2584 XX could either result in decreased efficacy or an unacceptable benefit-risk assessment, and where replacement of that concomitant medication with a safe equivalent drug is not possible (cf. protocol section 4.2.2.2 and the Investigator Site File).
  5. Patients with active liver disease or history of any significant liver disease.
  6. Any clinically significant illness or unstable disease which according to investigator judgement may either put the patient at risk because of participation in the study or may influence the results of the study or the patients ability to participate.
  7. Patient with serum creatinine and/or white blood cell count >1.5 x ULN at screening.

    (Repeat laboratory is allowed once between screening and randomisation prior to excluding the patient)

  8. Patients with ALT, AST and/or total bilirubin > 1.5xULN at screening (Repeat laboratory is allowed once between screening and randomisation prior to excluding the patient)
  9. Abnormal values of other laboratory parameters at screening that would define a clinically significant disease as described in # 6 above (Repeat laboratory is allowed once between screening and randomisation prior to excluding the patient)
  10. Positive testing at screening, or history of HIV or hepatitis B or hepatitis C, or any serious infection (requiring hospitalisation or parenteral antibiotic therapy) in the past 3 months prior to screening
  11. History of malignancy in the past 5 years or suspicion of active malignant disease except treated cutaneous squamous cell or basal cell carcinoma
  12. Patients with the following findings at the screening visit that could interfere with cardiac repolarisation:

    • marked baseline prolongation of QT/QTc interval as measured on ECG (e.g. QTc interval >450ms);
    • history of additional risk factors for Torsade de pointe (e.g. heart failure, - hypokalemia, family history of long QT syndrome);
    • use of concomitant medications that prolong the QT/QTc interval
  13. History of drug or alcohol abuse within the past two years
  14. Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active woman who:

    • is pregnant or nursing
    • is of child bearing potential and not practicing acceptable methods of birth control, or does not plan to continue practising an acceptable method throughout the study (acceptable methods of birth control include surgical sterilisation, intrauterine devices, double barrier, male partner sterilisation, but not hormonal contraceptives**) [A negative serum pregnancy test at screening (Visit 1) and a negative urine test prior to randomisation (Visit 2) are required]
  15. Patient not willing to avoid excess sun exposure during the trial duration
  16. Patients who have taken an investigational drug, within the last 4 weeks or 5 half lives (which ever is greater) prior to randomisation [Patients who have been treated with any investigational antibody or fusion protein within the past 12 weeks before randomisation are excluded]
  17. Known allergy to BIRT 2584 XX or to the excipients used for tablet formulation
  18. Body mass index > 34 kg/m2 at screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333411

  Show 48 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator BI France S.A.S.
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00333411     History of Changes
Other Study ID Numbers: 1206.5
Study First Received: June 2, 2006
Last Updated: June 13, 2014
Health Authority: France: Agence Francaise de Securite Sanitaire des Produits de Sante
Germany: Bfarm
The Netherlands: Medical Ethics Testing Committee (IEC)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Finland: National Agency of Medicines
Denmark: Danish Medicines Agency
Spain: Ministry of Health
Belgium: SPF
Sweden: Medical Products Agency
Canada: Health Canada

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 28, 2014