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Study terminated-Sponsor's decision
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This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SUNPG1622 I | Experimental | SUNPG1622 I dose |
|
| Placebo | Placebo Comparator | Placebo dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUNPG1622 I dose | Drug | Injection |
| |
| Placebo dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPARC Site 1 | Middleburg Heights | Ohio | 44130 | United States | ||
| SPARC site 3 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37162744 | Derived | Peters E, Chou RC, Rozzo SJ, Yao SL, Fructuoso FJG. A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of Tildrakizumab Efficacy and Safety in Patients With Active Ankylosing Spondylitis. J Clin Rheumatol. 2023 Aug 1;29(5):223-229. doi: 10.1097/RHU.0000000000001973. Epub 2023 May 10. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | SUNPG1622 I | SUNPG1622 I dose: Injection |
| FG001 | Placebo | Placebo dose: Injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SUNPG1622 I | SUNPG1622 I dose: Injection |
| BG001 | Placebo | Placebo dose: Injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates at Week 24 by Cohort (Full Analysis Set) | Posted | Number | percentage of participants | Week 24 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: SUNPG1622 or Placebo | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's disease | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypercholesterolaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Mudgal Kothekar | Sun Pharma Advanced Research Company Limited | 912266455645 | clinical.trials@sparcmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 14, 2017 | Sep 16, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 1, 2019 | Nov 19, 2020 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D000089202 | Non-Radiographic Axial Spondyloarthritis |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| Drug |
Injection |
|
| Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |
| Budapest |
| Hungary |
| SPARC site 3 | Elblag | Poland |
| SPARC site 2 | A Coruña | Spain |
| withdrew participation |
|
| Lost to Follow-up |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | 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. | ASAS20 Response Rates up to Week 24 by Cohort (Full Analysis Set) | Posted | Number | percentage of participants | Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |
|
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| 12 |
| 101 |
| EG001 | Part 2: Treatment Follow-up (SUNPG16221 Dose Injection) | 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 | 0 | 101 | 1 | 101 | 13 | 101 |
| EG002 | Part 3: Washout | Group 3: Washout period between Week 52 and Week 72. Safety results are provided per the following: Group 3: washout period | 0 | 101 | 3 | 101 | 0 | 101 |
| Hyperplasia | Gastrointestinal disorders | Systematic Assessment |
|
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Injection site erythema | General disorders | Systematic Assessment |
|
| Pyrexia | Infections and infestations | Systematic Assessment |
|
| Blood glucose increased | Metabolism and nutrition disorders | Systematic Assessment |
|
| Blood pressure increased | Cardiac disorders | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Weight increased | Investigations | Systematic Assessment |
|
| Hyperplasia | General disorders | Systematic Assessment |
|
| Injection site joint erythema | General disorders | Systematic Assessment |
|
| Glucose tolerance impaired | Endocrine disorders | Systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| Week 16 |
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| Week 12 |
|
| Week 8 |
|
| Week 4 |
|
| Week 1 |
|