Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety Study of SUNPG1622

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: NCT02980705
Recruitment Status : Terminated (Study terminated-Sponsor's decision)
First Posted : December 2, 2016
Results First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Global FZE

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis
Interventions Drug: SUNPG1622 I dose
Drug: Placebo dose
Enrollment 180
Recruitment Details It was planned that 90 subjects with active AS and 90 subjects with nr-axSpA would be enrolled to ensure completion of 180 subjects. One hundred and one subjects with active AS were actually enrolled and randomized and 82 subjects completed the study.
Pre-assignment Details  
Arm/Group Title SUNPG1622 I Placebo
Hide Arm/Group Description SUNPG1622 I dose: Injection Placebo dose: Injection
Period Title: Overall Study
Started 50 51
Completed 42 40
Not Completed 8 11
Reason Not Completed
Adverse Event             0             1
Withdrawal by Subject             6             9
withdrew participation             0             1
Lost to Follow-up             2             0
Arm/Group Title SUNPG1622 I Placebo Total
Hide Arm/Group Description SUNPG1622 I dose: Injection Placebo dose: Injection Total of all reporting groups
Overall Number of Baseline Participants 50 51 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age, mean years (SD) Number Analyzed 50 participants 51 participants 101 participants
39.8  (9.18) 39.1  (11.00) 39.5  (10.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 101 participants
Female
11
  22.0%
13
  25.5%
24
  23.8%
Male
39
  78.0%
38
  74.5%
77
  76.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 101 participants
Hispanic or Latino
2
   4.0%
0
   0.0%
2
   2.0%
Not Hispanic or Latino
48
  96.0%
51
 100.0%
99
  98.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 101 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.0%
0
   0.0%
1
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   2.0%
1
   1.0%
White
48
  96.0%
50
  98.0%
98
  97.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   2.0%
0
   0.0%
1
   1.0%
1.Primary Outcome
Title Assessment of SpondyloArthritis International Society 20 Response Rates
Hide Description Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]). The results for this endpoint is as per the Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates (Full Analysis Set).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates at Week 24 by Cohort (Full Analysis Set)
Arm/Group Title SUNPG1622 I Placebo
Hide Arm/Group Description:
SUNPG1622 I dose: Injection
Placebo dose: Injection
Overall Number of Participants Analyzed 50 51
Measure Type: Number
Unit of Measure: percentage of participants
74.00 80.39
2.Secondary Outcome
Title Assessment of SpondyloArthritis International Society 20 Response Rates
Hide Description Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]). The following are the specific time points at which the outcome measure was assessed and for which data are presented : Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24.
Time Frame Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ASAS20 Response Rates up to Week 24 by Cohort (Full Analysis Set)
Arm/Group Title SUNPG1622 I Placebo
Hide Arm/Group Description:
SUNPG1622 I dose: Injection
Placebo dose: Injection
Overall Number of Participants Analyzed 50 51
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 74.00 83.67
Week 20 68.00 59.18
Week 16 64.00 57.14
Week 12 50.00 46.94
Week 8 40.00 36.73
Week 4 30.00 22.00
Week 1 16.33 20.00
Time Frame Week 72
Adverse Event Reporting Description

It is the approximate duration over which adverse event data were collected.

Analysis of adverse events was performed in 3 Parts:

Part 1: SUNPG1622→Placebo; from Day 1 to Week 24 Part 2: Treatment follow-up (SUNPG16221 dose injection); from Week 24 to Week 52 Part 3: Washout period between Week 52 and Week 72. In Part 3 of the study, all subjects underwent IMP washout and no subjects received SUNPG1622.

 
Arm/Group Title Part 1: SUNPG1622 or Placebo Part 2: Treatment Follow-up (SUNPG16221 Dose Injection) Part 3: Washout
Hide Arm/Group Description

Group 1: SUNPG1622 or Placebo; From Baseline to Week 24.

Safety results are provided per the following:

Group 1: Subjects recieved either SUNPG1622 or Placebo

Group 2: Treatment follow-up (SUNPG16221 dose injection); from Week 24 to Week 52.

Safety results are provided per the following:

Group 2: Subjects recieved SUNPG1622

Group 3: Washout period between Week 52 and Week 72.

Safety results are provided per the following:

Group 3: washout period

All-Cause Mortality
Part 1: SUNPG1622 or Placebo Part 2: Treatment Follow-up (SUNPG16221 Dose Injection) Part 3: Washout
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/101 (0.00%)      0/101 (0.00%)      0/101 (0.00%)    
Hide Serious Adverse Events
Part 1: SUNPG1622 or Placebo Part 2: Treatment Follow-up (SUNPG16221 Dose Injection) Part 3: Washout
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/101 (0.00%)      1/101 (0.99%)      3/101 (2.97%)    
Gastrointestinal disorders       
Crohn's disease   0/101 (0.00%)  0 0/101 (0.00%)  0 1/101 (0.99%)  1
Hyperplasia   0/101 (0.00%)  0 1/101 (0.99%)  1 0/101 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Fibroadenoma of breast   0/101 (0.00%)  0 0/101 (0.00%)  0 1/101 (0.99%)  1
Pancreatic carcinoma metastatic   0/101 (0.00%)  0 0/101 (0.00%)  0 1/101 (0.99%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Part 1: SUNPG1622 or Placebo Part 2: Treatment Follow-up (SUNPG16221 Dose Injection) Part 3: Washout
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/101 (11.88%)      13/101 (12.87%)      0/101 (0.00%)    
Cardiac disorders       
Blood pressure increased   0/101 (0.00%)  0 1/101 (0.99%)  1 0/101 (0.00%)  0
Endocrine disorders       
Glucose tolerance impaired   0/101 (0.00%)  0 1/101 (0.99%)  1 0/101 (0.00%)  0
Gastrointestinal disorders       
Gastrointestinal disorders   0/101 (0.00%)  0 1/101 (0.99%)  1 0/101 (0.00%)  0
General disorders       
Injection site erythema   0/101 (0.00%)  0 1/101 (0.99%)  1 0/101 (0.00%)  0
Hyperplasia   0/101 (0.00%)  0 1/101 (0.99%)  1 0/101 (0.00%)  0
Injection site joint erythema   0/101 (0.00%)  0 1/101 (0.99%)  1 0/101 (0.00%)  0
Infections and infestations       
Pyrexia   1/101 (0.99%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Herpes simplex   1/101 (0.99%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Sinusitis   1/101 (0.99%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Upper respiratory tract infection   1/101 (0.99%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Vaginal infection   1/101 (0.99%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Infections and infestations   0/101 (0.00%)  0 1/101 (0.99%)  1 0/101 (0.00%)  0
Bronchitis   0/101 (0.00%)  0 1/101 (0.99%)  1 0/101 (0.00%)  0
Investigations       
Alanine aminotransferase increased   1/101 (0.99%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Aspartate aminotransferase increased   1/101 (0.99%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Gamma-glutamyltransferase increased   1/101 (0.99%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Blood creatine phosphokinase increased   1/101 (0.99%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Weight increased   0/101 (0.00%)  0 1/101 (0.99%)  1 0/101 (0.00%)  0
Metabolism and nutrition disorders       
Hypercholesterolaemia   0/101 (0.00%)  0 1/101 (0.99%)  1 0/101 (0.00%)  0
Blood glucose increased   0/101 (0.00%)  0 1/101 (0.99%)  1 0/101 (0.00%)  0
Dyslipidaemia   1/101 (0.99%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dermatitis allergic   1/101 (0.99%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Erythema   1/101 (0.99%)  1 0/101 (0.00%)  0 0/101 (0.00%)  0
Skin and subcutaneous tissue disorders   0/101 (0.00%)  0 1/101 (0.99%)  1 0/101 (0.00%)  0
Dermatitis allergic   0/101 (0.00%)  0 1/101 (0.99%)  1 0/101 (0.00%)  0
Indicates events were collected by systematic assessment
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: Dr Mudgal Kothekar
Organization: Sun Pharma Advanced Research Company Limited
Phone: 912266455645
EMail: clinical.trials@sparcmail.com
Layout table for additonal information
Responsible Party: Sun Pharma Global FZE
ClinicalTrials.gov Identifier: NCT02980705    
Other Study ID Numbers: CLR_16_22
First Submitted: November 30, 2016
First Posted: December 2, 2016
Results First Submitted: September 16, 2020
Results First Posted: February 21, 2021
Last Update Posted: February 21, 2021