Efficacy and Safety of Omalizumab in Bullous Pemphigoid

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Janet Fairley, University of Iowa
ClinicalTrials.gov Identifier:
NCT00472030
First received: May 8, 2007
Last updated: September 17, 2012
Last verified: September 2012
Results First Received: June 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bullous Pemphigoid
Interventions: Drug: Omalizumab
Drug: prednisone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Omalizumab Treatment Arm Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 14 weeks.
Prednisone Standard Therapy Treatment Arm The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 milligrams per kilogram per day (mg/kg/day).

Participant Flow:   Overall Study
    Omalizumab Treatment Arm     Prednisone Standard Therapy Treatment Arm  
STARTED     2     0  
COMPLETED     1     0  
NOT COMPLETED     1     0  
Physician Decision                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Omalizumab Treatment Arm Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 16 weeks.
Prednisone Standard Therapy Treatment Arm The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
Total Total of all reporting groups

Baseline Measures
    Omalizumab Treatment Arm     Prednisone Standard Therapy Treatment Arm     Total  
Number of Participants  
[units: participants]
  2     0     2  
Age  
[units: participants]
     
<=18 years     0         0  
Between 18 and 65 years     0         0  
>=65 years     2         2  
Age  
[units: years]
Mean ± Standard Deviation
  78  ± 0         78  ± 0  
Gender  
[units: participants]
     
Female     2         2  
Male     0         0  
Region of Enrollment  
[units: participants]
     
United States     2         2  



  Outcome Measures
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1.  Primary:   Median Time From First Dose of Omalizumab Treatment to Cessation of New Blisters.   [ Time Frame: Up to 24 weeks ]

2.  Primary:   Percent Decrease in the Total Body Surface Area Affected By Active Bullous Pemphigoid Skin Disease From Day 0 to Week 24.   [ Time Frame: Up to 24 weeks ]

3.  Primary:   Median Increase in Prednisone Dosage Measured at Week 4, 8 and 24 in Patients Treated With Omalizumab and in Patients Receiving Standard Therapy.   [ Time Frame: Week 4, Week 8 and Week 24 ]

4.  Secondary:   Decrease in Anti-BP180 IgG (Immunoglobulin G Anti-Bullous Pemphigoid 180 Antibody) Following Treatment With Omalizumab.   [ Time Frame: Up to 24 weeks ]

5.  Secondary:   Decrease in Eosinophil Levels Following Treatment With Omalizumab.   [ Time Frame: Baseline, 24 weeks. ]

6.  Secondary:   Decrease in Anti-BP230 Antibody IgG (Anti-bullous Pemphigoid 230 Antibody Immunoglobulin G) At Baseline and Week 16   [ Time Frame: Up to 24 weeks ]

7.  Secondary:   Change in Histamine Release Assay Following Treatment With Omalizumab.   [ Time Frame: Up to 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations of this trial include low enrollment of research subjects and the need to withdraw a subject from the trial.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Janet Fairley, M.D.
Organization: University of Iowa
phone: 319-384-8560
e-mail: janet-fairley@uiowa.edu


Publications:

Responsible Party: Janet Fairley, University of Iowa
ClinicalTrials.gov Identifier: NCT00472030     History of Changes
Other Study ID Numbers: 100569
Study First Received: May 8, 2007
Results First Received: June 26, 2012
Last Updated: September 17, 2012
Health Authority: United States: Food and Drug Administration