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Trial record 7 of 35 for:    "Churg Strauss syndrome"

A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis

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ClinicalTrials.gov Identifier: NCT02020889
Recruitment Status : Completed
First Posted : December 25, 2013
Results First Posted : January 26, 2018
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Churg-Strauss Syndrome
Interventions: Biological: Mepolizumab
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible participants at screening and run-in visit, entered a 52 week study treatment phase followed by 8-week follow-up phase. The total duration for the study participation was approximately 64 weeks.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 151 participants with a history of relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) were screened, out of which 4 were screen failures and 11 were run-in failures. 136 participants completed run-in period and received Mepolizumab 300 milligram (mg) or placebo in a randomized manner in the treatment phase.

Reporting Groups
  Description
Placebo Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Mepolizumab 300mg Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.

Participant Flow:   Overall Study
    Placebo   Mepolizumab 300mg
STARTED   68   68 
COMPLETED   61   65 
NOT COMPLETED   7   3 
Adverse Event                0                1 
Lack of Efficacy                1                0 
Lost to Follow-up                1                0 
Physician Decision                2                0 
Withdrawal by Subject                3                2 



  Baseline Characteristics

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
Placebo Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
Mepolizumab 300mg Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
Total Total of all reporting groups

Baseline Measures
   Placebo   Mepolizumab 300mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 68   68   136 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.2  (14.32)   48.7  (12.39)   48.5  (13.34) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      38  55.9%      42  61.8%      80  58.8% 
Male      30  44.1%      26  38.2%      56  41.2% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race customized       
American Indian or Alaskan Native      0   0.0%      1   1.5%      1   0.7% 
Asian - Japanese Heritage      3   4.4%      3   4.4%      6   4.4% 
Asian - South East Asian Heritage      2   2.9%      0   0.0%      2   1.5% 
White - Arabic/North African Heritage      0   0.0%      2   2.9%      2   1.5% 
White - White/Caucasian/European Heritage      61  89.7%      62  91.2%      123  90.4% 
Mixed Race      2   2.9%      0   0.0%      2   1.5% 


  Outcome Measures

1.  Primary:   Number of Participants in Each Category of Accrued Duration of Remission   [ Time Frame: Up to Week 52 ]

2.  Primary:   Number of Participants Who Are in Remission at 36 and 48 Weeks   [ Time Frame: Week 36 and Week 48 ]

3.  Secondary:   Time to First EGPA Relapse   [ Time Frame: Up to Week 52 ]

4.  Secondary:   Number of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period.   [ Time Frame: Week 48 and Week52 ]

5.  Secondary:   Number of Participants Who Achieved Remission Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period   [ Time Frame: Up to Week 52 ]

6.  Secondary:   Number of Participants in Each Category of Accrued Duration of Remission   [ Time Frame: Up to Week 52 ]

7.  Secondary:   Number of Participants Who Are in Remission at 36 and 48 Weeks   [ Time Frame: Week 36 and Week 48 ]

8.  Secondary:   Number of Participants Who Achieved Remission (BVAS=0 and Prednisolone/Prednisone <=7.5 mg/Day) Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period   [ Time Frame: Up to Week 52 ]

9.  Secondary:   Number of Participants With Local and Systemic Adverse Events (AEs)   [ Time Frame: Up to Week 52 ]

10.  Secondary:   Change From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) Levels   [ Time Frame: Baseline and up to Week 60 ]

11.  Secondary:   Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels   [ Time Frame: Baseline and up to Week 60 ]

12.  Secondary:   Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels   [ Time Frame: Baseline and up to Week 60 ]

13.  Secondary:   Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol Levels   [ Time Frame: Baseline and up to Week 60 ]

14.  Secondary:   Change From Baseline in Clinical Chemistry Parameter of Troponin Levels   [ Time Frame: Baseline and up to Week 60 ]

15.  Secondary:   Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels   [ Time Frame: Baseline and up to Week 60 ]

16.  Secondary:   Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels   [ Time Frame: Baseline and up to Week 60 ]

17.  Secondary:   Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels   [ Time Frame: Baseline and up to Week 60 ]

18.  Secondary:   Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels   [ Time Frame: Baseline and up to Week 60 ]

19.  Secondary:   Change From Baseline in Hematology Parameters of Erythrocytes Levels   [ Time Frame: Baseline and up to Week 60 ]

20.  Secondary:   Number of Participants With Anti-Mepolizumab Antibodies   [ Time Frame: Up to Week 60 ]

21.  Secondary:   Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels   [ Time Frame: Baseline up to Week 60 ]

22.  Secondary:   Change From Baseline in Pulse Rate   [ Time Frame: Baseline and up to Week 60 ]

23.  Secondary:   Change From Baseline in Body Temperature   [ Time Frame: Baseline and up to Week 60 ]

24.  Secondary:   Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values   [ Time Frame: Baseline and up to Week 60 ]

25.  Secondary:   Maximum Change From Baseline in QTcF and QTcB Values   [ Time Frame: Baseline and up to Week 60 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02020889     History of Changes
Other Study ID Numbers: 115921
First Submitted: December 19, 2013
First Posted: December 25, 2013
Results First Submitted: August 29, 2017
Results First Posted: January 26, 2018
Last Update Posted: January 31, 2018