Trial Outcomes & Findings for Efficacy and Safety Study of SUNPG1622 (NCT NCT02980705)
NCT ID: NCT02980705
Last Updated: 2021-11-01
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
180 participants
Primary outcome timeframe
Week 24
Results posted on
2021-11-01
Participant Flow
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.
Participant milestones
| Measure |
SUNPG1622 I
SUNPG1622 I dose: Injection
|
Placebo
Placebo dose: Injection
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
|
Overall Study
COMPLETED
|
42
|
40
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
Reasons for withdrawal
| Measure |
SUNPG1622 I
SUNPG1622 I dose: Injection
|
Placebo
Placebo dose: Injection
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
9
|
|
Overall Study
withdrew participation
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Efficacy and Safety Study of SUNPG1622
Baseline characteristics by cohort
| Measure |
SUNPG1622 I
n=50 Participants
SUNPG1622 I dose: Injection
|
Placebo
n=51 Participants
Placebo dose: Injection
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age, mean years (SD)
|
39.8 years
STANDARD_DEVIATION 9.18 • n=5 Participants
|
39.1 years
STANDARD_DEVIATION 11.00 • n=7 Participants
|
39.5 years
STANDARD_DEVIATION 10.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates at Week 24 by Cohort (Full Analysis Set)
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).
Outcome measures
| Measure |
SUNPG1622 I
n=50 Participants
SUNPG1622 I dose: Injection
|
Placebo
n=51 Participants
Placebo dose: Injection
|
|---|---|---|
|
Assessment of SpondyloArthritis International Society 20 Response Rates
|
74.00 percentage of participants
|
80.39 percentage of participants
|
SECONDARY outcome
Timeframe: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24Population: ASAS20 Response Rates up to Week 24 by Cohort (Full Analysis Set)
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.
Outcome measures
| Measure |
SUNPG1622 I
n=50 Participants
SUNPG1622 I dose: Injection
|
Placebo
n=51 Participants
Placebo dose: Injection
|
|---|---|---|
|
Assessment of SpondyloArthritis International Society 20 Response Rates
Week 24
|
74.00 percentage of participants
|
83.67 percentage of participants
|
|
Assessment of SpondyloArthritis International Society 20 Response Rates
Week 20
|
68.00 percentage of participants
|
59.18 percentage of participants
|
|
Assessment of SpondyloArthritis International Society 20 Response Rates
Week 16
|
64.00 percentage of participants
|
57.14 percentage of participants
|
|
Assessment of SpondyloArthritis International Society 20 Response Rates
Week 12
|
50.00 percentage of participants
|
46.94 percentage of participants
|
|
Assessment of SpondyloArthritis International Society 20 Response Rates
Week 8
|
40.00 percentage of participants
|
36.73 percentage of participants
|
|
Assessment of SpondyloArthritis International Society 20 Response Rates
Week 4
|
30.00 percentage of participants
|
22.00 percentage of participants
|
|
Assessment of SpondyloArthritis International Society 20 Response Rates
Week 1
|
16.33 percentage of participants
|
20.00 percentage of participants
|
Adverse Events
Part 1: SUNPG1622 or Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Part 2: Treatment Follow-up (SUNPG16221 Dose Injection)
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Part 3: Washout
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: SUNPG1622 or Placebo
n=101 participants at risk
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
|
Part 2: Treatment Follow-up (SUNPG16221 Dose Injection)
n=101 participants at risk
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
|
Part 3: Washout
n=101 participants at risk
Group 3: Washout period between Week 52 and Week 72.
Safety results are provided per the following:
Group 3: washout period
|
|---|---|---|---|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/101 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
|
Gastrointestinal disorders
Hyperplasia
|
0.00%
0/101 • Week 72
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.
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/101 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/101 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
Other adverse events
| Measure |
Part 1: SUNPG1622 or Placebo
n=101 participants at risk
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
|
Part 2: Treatment Follow-up (SUNPG16221 Dose Injection)
n=101 participants at risk
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
|
Part 3: Washout
n=101 participants at risk
Group 3: Washout period between Week 52 and Week 72.
Safety results are provided per the following:
Group 3: washout period
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/101 • Week 72
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.
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Investigations
Alanine aminotransferase increased
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Investigations
Aspartate aminotransferase increased
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
General disorders
Injection site erythema
|
0.00%
0/101 • Week 72
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.
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Infections and infestations
Pyrexia
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.00%
0/101 • Week 72
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.
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Cardiac disorders
Blood pressure increased
|
0.00%
0/101 • Week 72
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.
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Infections and infestations
Herpes simplex
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Infections and infestations
Sinusitis
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Infections and infestations
Vaginal infection
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/101 • Week 72
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.
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Investigations
Weight increased
|
0.00%
0/101 • Week 72
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.
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
General disorders
Hyperplasia
|
0.00%
0/101 • Week 72
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.
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
General disorders
Injection site joint erythema
|
0.00%
0/101 • Week 72
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.
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Endocrine disorders
Glucose tolerance impaired
|
0.00%
0/101 • Week 72
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.
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
0.00%
0/101 • Week 72
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.
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Infections and infestations
Infections and infestations
|
0.00%
0/101 • Week 72
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.
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/101 • Week 72
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.
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
0.00%
0/101 • Week 72
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.
|
0.99%
1/101 • Number of events 1 • Week 72
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.
|
0.00%
0/101 • Week 72
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.
|
Additional Information
Dr Mudgal Kothekar
Sun Pharma Advanced Research Company Limited
Phone: 912266455645
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER