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A Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With ANCA-Associated Vasculitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01363388
Recruitment Status : Completed
First Posted : June 1, 2011
Results First Posted : July 27, 2020
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
ChemoCentryx

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Vasculitis
Interventions Drug: Placebo
Drug: CCX168
Enrollment 67
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo BID Plus 60 mg Prednisone CCX168 30 mg BID Plus 20 mg Prednisone CCX168 30 mg BID Without Prednisone
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
Started 23 22 22
Completed 18 19 18
Not Completed 5 3 4
Arm/Group Title Placebo BID Plus 60 mg Prednisone Avacopan 30 mg BID Plus 20 mg Prednisone Avacopan 30 mg BID Without Prednisone Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 23 22 22 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 22 participants 22 participants 67 participants
59.1  (14.0) 57.0  (14.2) 57.4  (14.0) 57.9  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 22 participants 22 participants 67 participants
Female
6
  26.1%
8
  36.4%
6
  27.3%
20
  29.9%
Male
17
  73.9%
14
  63.6%
16
  72.7%
47
  70.1%
1.Primary Outcome
Title Proportion of Subjects Achieving at Least 50% Reduction in Birmingham Vasculitis Activity Score [BVAS] by Week 12 and No Worsening in Any Body System
Hide Description [Not Specified]
Time Frame 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo BID Plus 60 mg Prednisone CCX168 30 mg BID Plus 20 mg Prednisone CCX168 30 mg BID Without Prednisone
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 20 22 21
Measure Type: Count of Participants
Unit of Measure: Participants
14
  70.0%
19
  86.4%
17
  81.0%
Time Frame 84-day treatment period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo BID Plus 60 mg Prednisone Avacopan 30 mg BID Plus 20 mg Prednisone Avacopan 30 mg BID Without Prednisone
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Placebo BID Plus 60 mg Prednisone Avacopan 30 mg BID Plus 20 mg Prednisone Avacopan 30 mg BID Without Prednisone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo BID Plus 60 mg Prednisone Avacopan 30 mg BID Plus 20 mg Prednisone Avacopan 30 mg BID Without Prednisone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/23 (17.39%)   3/22 (13.64%)   8/22 (36.36%) 
Infections and infestations       
Infection  1/23 (4.35%)  1/22 (4.55%)  1/22 (4.55%) 
Investigations       
Hepatic and pancreatic enzyme increased  0/23 (0.00%)  0/22 (0.00%)  1/22 (4.55%) 
C-reactive protein increased  0/23 (0.00%)  0/22 (0.00%)  1/22 (4.55%) 
Metabolism and nutrition disorders       
Dehydration  1/23 (4.35%)  0/22 (0.00%)  0/22 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain and vertebral fracture  1/23 (4.35%)  0/22 (0.00%)  0/22 (0.00%) 
Musculoskeletal chest pain  0/23 (0.00%)  1/22 (4.55%)  0/22 (0.00%) 
Renal and urinary disorders       
Haematuria  0/23 (0.00%)  1/22 (4.55%)  0/22 (0.00%) 
Renal impairment  0/23 (0.00%)  0/22 (0.00%)  1/22 (4.55%) 
Skin and subcutaneous tissue disorders       
Rash  0/23 (0.00%)  0/22 (0.00%)  1/22 (4.55%) 
Vascular disorders       
Vasculitis  1/23 (4.35%)  1/22 (4.55%)  3/22 (13.64%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo BID Plus 60 mg Prednisone Avacopan 30 mg BID Plus 20 mg Prednisone Avacopan 30 mg BID Without Prednisone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/22 (0.00%)   0/22 (0.00%) 
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: ChemoCentryx
Phone: 650-210-2900
Layout table for additonal information
Responsible Party: ChemoCentryx
ClinicalTrials.gov Identifier: NCT01363388    
Other Study ID Numbers: CL002_168
First Submitted: May 26, 2011
First Posted: June 1, 2011
Results First Submitted: July 7, 2020
Results First Posted: July 27, 2020
Last Update Posted: July 27, 2020