Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333411
Status:
COMPLETED
Last Update Posted:
2014-06-19
First Post:
2006-06-02
Brief Title:
Double-blind Randomised Placebo-controlled Trial Investigating BIRT 2584 XX in Patients With ModerateSevere Psoriasis
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The proposed study is a phase 2ab international multicentre clinical trial The general aim of this study is to investigate the safety and efficacy clinical proof of concept of three different doses 100 mg 300 mg or 500 mg of BIRT 2584 XX tablets administered orally once daily compared to placebo tablets for the treatment of patients with moderate to severe plaque-type psoriasis patients who are candidates for systemic treatment or phototherapy This study may also provide dose-finding information for future pivotal studies
The response to treatment will be measured for all patients in the study after 12 weeks of treatment using the PASI as the primary endpoint and also the sPGA Both instruments evaluate the clinical severity of plaque-type psoriatic lesions Training on PASI and sPGA assessment will be provided in order to decrease inter-observer variability The sPGA is thus to be validated for future phase 3 trials
After 12 weeks of treatment only those patients with a response equivalent or better than PASI50 and with a satisfactory safety experience will enter a 12 week extension of the treatment period The total time of exposure to study drug in this subgroup of patients will be 24 weeks All other study patients will terminate treatment with study drug after 12 weeks
In addition the durability of remissionresponse and the occurrence of any relapse or rebound during the treatment with study drug and after the end of treatment will be assessed in an 8 weeks follow-up period The follow-up period is applicable to all study participants who have taken at least one dose of study drug It initiates after the last dose of study medication has been taken irrespective of the duration of the patients actual treatment period
The trial will use a modified dose-escalation scheme The randomisation to the 500 mg treatment arm will initiate only after a Data Safety Monitoring Board DSMB decision on the safety of the other treatment arms An IVRS will be used for randomisation in this trial
Ninety 90 patients are required per dose group With four groups and an overall 1111 randomisation scheme a total of 360 eligible patients are planned to be randomised to treatment
Study Hypothesis
Psoriasis is a chronic inflammatory disease that leads to skin sores These skin sores are dependent on the rate of growth of the skin which is driven by an underlying corresponding degree of local inflammation The skin inflammation is caused by different cell types that move from the blood vessels into the skin This cell movement is a result of interaction of different proteins One of these proteins is called LFA-1 Lymphocyte Function Associated Antigen 1 LFA-1 is then a promising target for psoriasis therapy BIRT 2584 XX will block the passage of these inflammatory cells from the blood to the skin by blocking LFA-1 and thus indirectly block the inflammatory process BIRT 2584 XX can also block the activation of local inflammatory cells which altogether may reduce the signs and symptoms of psoriasis
A dose-dependent effect of BIRT 2584 XX was observed on a set of markers in the blood that are believed to correlate with the severity of the inflammatory process leading to psoriasis
Comparisons
In this clinical study BIRT 2584 XX in a dose of 100 mg 300 mg or 500 mg or placebo will be given once daily Patients will receive the same treatment throughout the study
Patients will have a 1 in 4 chance 25 of being allocated to placebo treatment The placebo is identical in appearance compared to any one of the three dose groups with BIRT 2584 XX but does not contain any active ingredient The purpose of a comparison with placebo is to ensure a more reliable assessment of the therapeutic effect and of the side effects of BIRT 2584 XX
The response to treatment will be measured for all patients in the study after 12 weeks of treatment using the PASI as the primary endpoint and also the sPGA Both instruments evaluate the clinical severity of plaque-type psoriatic lesions Training on PASI and sPGA assessment will be provided in order to decrease inter-observer variability The sPGA is thus to be validated for future phase 3 trials
After 12 weeks of treatment only those patients with a response equivalent or better than PASI50 and with a satisfactory safety experience will enter a 12 week extension of the treatment period The total time of exposure to study drug in this subgroup of patients will be 24 weeks All other study patients will terminate treatment with study drug after 12 weeks
In addition the durability of remissionresponse and the occurrence of any relapse or rebound during the treatment with study drug and after the end of treatment will be assessed in an 8 weeks follow-up period The follow-up period is applicable to all study participants who have taken at least one dose of study drug It initiates after the last dose of study medication has been taken irrespective of the duration of the patients actual treatment period
The trial will use a modified dose-escalation scheme The randomisation to the 500 mg treatment arm will initiate only after a Data Safety Monitoring Board DSMB decision on the safety of the other treatment arms An IVRS will be used for randomisation in this trial
Ninety 90 patients are required per dose group With four groups and an overall 1111 randomisation scheme a total of 360 eligible patients are planned to be randomised to treatment
Study Hypothesis
Psoriasis is a chronic inflammatory disease that leads to skin sores These skin sores are dependent on the rate of growth of the skin which is driven by an underlying corresponding degree of local inflammation The skin inflammation is caused by different cell types that move from the blood vessels into the skin This cell movement is a result of interaction of different proteins One of these proteins is called LFA-1 Lymphocyte Function Associated Antigen 1 LFA-1 is then a promising target for psoriasis therapy BIRT 2584 XX will block the passage of these inflammatory cells from the blood to the skin by blocking LFA-1 and thus indirectly block the inflammatory process BIRT 2584 XX can also block the activation of local inflammatory cells which altogether may reduce the signs and symptoms of psoriasis
A dose-dependent effect of BIRT 2584 XX was observed on a set of markers in the blood that are believed to correlate with the severity of the inflammatory process leading to psoriasis
Comparisons
In this clinical study BIRT 2584 XX in a dose of 100 mg 300 mg or 500 mg or placebo will be given once daily Patients will receive the same treatment throughout the study
Patients will have a 1 in 4 chance 25 of being allocated to placebo treatment The placebo is identical in appearance compared to any one of the three dose groups with BIRT 2584 XX but does not contain any active ingredient The purpose of a comparison with placebo is to ensure a more reliable assessment of the therapeutic effect and of the side effects of BIRT 2584 XX
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None