Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis
Conditions
Brief summary
This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622.
Interventions
DRUGSUNPG1622 I dose
Injection
DRUGPlacebo dose
Injection
Sponsors
Sun Pharmaceutical Industries Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has provided informed written consent * Subject is ≥ 18 years of age at time of Screening * Subject must be on a stable dose of NSAID for ≥ 2 weeks prior to initiation of investigational product * Subject has a negative test for TB within 4 weeks before initiating IMP
Exclusion criteria
* Subjects with known diagnosis of fibromyalgia or complex regional pain syndromes * Active uveitis or symptomatic inflammatory bowel disease requiring therapy at screening * Radiographic evidence of total ankylosis of the spine * Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pre-treatment condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of SpondyloArthritis International Society 20 Response Rates | Week 24 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of SpondyloArthritis International Society 20 Response Rates | Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | 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. |
Countries
Hungary, Poland, Spain, United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| SUNPG1622 I SUNPG1622 I dose: Injection | 50 |
| Placebo Placebo dose: Injection | 51 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 9 |
| Overall Study | withdrew participation | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | SUNPG1622 I |
|---|---|---|---|
| Age, Customized Age, mean years (SD) | 39.1 years STANDARD_DEVIATION 11 | 39.5 years STANDARD_DEVIATION 10.1 | 39.8 years STANDARD_DEVIATION 9.18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants | 99 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 50 Participants | 98 Participants | 48 Participants |
| Sex: Female, Male Female | 13 Participants | 24 Participants | 11 Participants |
| Sex: Female, Male Male | 38 Participants | 77 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 101 | 0 / 101 |
| other Total, other adverse events | 12 / 101 | 13 / 101 | 0 / 101 |
| serious Total, serious adverse events | 0 / 101 | 1 / 101 | 3 / 101 |
Outcome results
Primary
Assessment of SpondyloArthritis International Society 20 Response Rates
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
Population: Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates at Week 24 by Cohort (Full Analysis Set)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SUNPG1622 I | Assessment of SpondyloArthritis International Society 20 Response Rates | 74.00 percentage of participants |
| Placebo | Assessment of SpondyloArthritis International Society 20 Response Rates | 80.39 percentage of participants |
Secondary
Assessment of SpondyloArthritis International Society 20 Response Rates
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
Population: ASAS20 Response Rates up to Week 24 by Cohort (Full Analysis Set)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SUNPG1622 I | Assessment of SpondyloArthritis International Society 20 Response Rates | Week 16 | 64.00 percentage of participants |
| SUNPG1622 I | Assessment of SpondyloArthritis International Society 20 Response Rates | Week 8 | 40.00 percentage of participants |
| SUNPG1622 I | Assessment of SpondyloArthritis International Society 20 Response Rates | Week 20 | 68.00 percentage of participants |
| SUNPG1622 I | Assessment of SpondyloArthritis International Society 20 Response Rates | Week 4 | 30.00 percentage of participants |
| SUNPG1622 I | Assessment of SpondyloArthritis International Society 20 Response Rates | Week 12 | 50.00 percentage of participants |
| SUNPG1622 I | Assessment of SpondyloArthritis International Society 20 Response Rates | Week 1 | 16.33 percentage of participants |
| SUNPG1622 I | Assessment of SpondyloArthritis International Society 20 Response Rates | Week 24 | 74.00 percentage of participants |
| Placebo | Assessment of SpondyloArthritis International Society 20 Response Rates | Week 1 | 20.00 percentage of participants |
| Placebo | Assessment of SpondyloArthritis International Society 20 Response Rates | Week 24 | 83.67 percentage of participants |
| Placebo | Assessment of SpondyloArthritis International Society 20 Response Rates | Week 20 | 59.18 percentage of participants |
| Placebo | Assessment of SpondyloArthritis International Society 20 Response Rates | Week 16 | 57.14 percentage of participants |
| Placebo | Assessment of SpondyloArthritis International Society 20 Response Rates | Week 12 | 46.94 percentage of participants |
| Placebo | Assessment of SpondyloArthritis International Society 20 Response Rates | Week 8 | 36.73 percentage of participants |
| Placebo | Assessment of SpondyloArthritis International Society 20 Response Rates | Week 4 | 22.00 percentage of participants |