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

NCT00333411 | Completed Phase 2

• 1 other identifier: 1206.5
• Study Type: interventional
• Target: 360
• Locations: 10 countries
• Sites: 48

Brief Summary

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Achievement of > 75% reduction from baseline in Psoriasis Area and Severity Index (PASI) score (PASI75 ) at 12 weeks

  12 weeks

Secondary Outcomes (1)

• 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

  12 and 24 weeks

Study Arms (4)

BIRT 2584 XX high dose

EXPERIMENTAL

Drug: BIRT 2584 XX

BIRT 2584 XX medium dose

EXPERIMENTAL

Drug: BIRT 2584 XX

BIRT 2584 XX low dose

EXPERIMENTAL

Drug: BIRT 2584 XX

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIRT 2584 XX DRUG

BIRT 2584 XX high dose; BIRT 2584 XX low dose; BIRT 2584 XX medium dose

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (48)

Dermatologie Kliniek

Antwerp, 2018, Belgium

Location

Hôpital Erasme

Brussels, 1070, Belgium

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

Boehringer Ingelheim Investigational Site

Calgary, Alberta, T2S 3B3, Canada

Location

Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Eastern Canada Cutaneous Research Associates Ltd.

Halifax, Nova Scotia, B3H 1Z4, Canada

Location

Boehringer Ingelheim Investigational Site

London, Ontario, N6A 3H7, Canada

Location

Boehringer Ingelheim Investigational Site

Markham, Ontario, L3P 7N8, Canada

Location

Boehringer Ingelheim Investigational Site

Waterloo, Ontario, N2J 1C4, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Dr. Wayne Carey

Montreal, Quebec, H3G 1C6, Canada

Location

Boehringer Ingelheim Investigational Site

Montreal, Quebec, H3H 1V4, Canada

Location

Boehringer Ingelheim Investigational Site

Sainte-Foy, Quebec, G1V 4X7, Canada

Location

Marselisborg Centret

Aarhus C, DK-8000, Denmark

Location

Amtssygehuset i Gentofte

Hellerup, DK-2900, Denmark

Location

Odense Universitetshospital

Odense C, 5000, Denmark

Location

Päijät-Hämeen keskussairaala

Lahti, FI-15850, Finland

Location

Hôpital Saint Jacques

Besançon, 25030, France

Location

Hôpital Dupuytren

Limoges, 87042, France

Location

Hôpital de L'Archet

Nice, 06202, France

Location

Hôpital Saint Louis

Paris, 75475, France

Location

CHU - Hôpital Nord

Saint-Priest-en-Jarez, 42277, France

Location

Hôpital Nord

Saint-Priest-en-Jarez, 42277, France

Location

Charite, Campus Virchow-Klinikum

Berlin, 10117, Germany

Location

St. Josef-Hospital

Bochum, 44791, Germany

Location

Universitätsklinikum an der TU Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91052, Germany

Location

Universitäts-Hautklinik

Freiburg im Breisgau, 79104, Germany

Location

Universitätsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

Otto-von-Guericke-Universität Magdeburg

Magdeburg, 39120, Germany

Location

Boehringer Ingelheim Investigational Site

Mahlow, 15831, Germany

Location

Johannes Gutenberg-Universität Mainz

Mainz, 55101, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Academic Medical Centre

Amsterdam, 1105 AZ, Netherlands

Location

University Medical Centre Nijmegen St. Radboud West

Nijmegen, 6525 GL, Netherlands

Location

Boehringer Ingelheim Investigational Site

Barcelona, 08025, Spain

Location

Servicio de Dermatología

Madrid, 28006, Spain

Location

Servicio de Dermatología

Madrid, 28041, Spain

Location

Karolinska Universitetssjukhuset Solna

Stockholm, 171 76, Sweden

Location

Aberdeen Royal Infirmary, Department of Dermatology

Aberdeen, AB25 2ZN, United Kingdom

Location

Cardiff University, Dermatology Department

Cardiff, CF14 4XN, United Kingdom

Location

Western Infirmary, Department of Dermatology

Glasgow, G11 6NT, United Kingdom

Location

Royal Free Hospital, Dermatology Department,

London, NW3 2QG, United Kingdom

Location

Skin Therapy Research Unit, St John's Inst of Dermatolology

London, SE1 7EH, United Kingdom

Location

George Eliot Hospital, Dermatology Department

Nuneaton, CV10 7DJ, United Kingdom

Location

Hope Hospital, The Dermatology Centre,

Salford, M6 8HD, United Kingdom

Location

Royal South Hants Hospital, Dept of Dermatology

Southampton, SO14 0YG, United Kingdom

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Boehringer Ingelheim Study Coordinator

  BI France S.A.S.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2006
• First Posted: June 5, 2006
• Study Start: June 1, 2006
• Primary Completion: June 1, 2008
• Last Updated: June 19, 2014

Record last verified: 2014-06

Locations

NL (2); SE (1); GB (8); FR (6); DK (3); FI (1); BE (3); CA (10); DE (11); ES (3)