Efficacy and Safety Study of SUNPG1623
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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: NCT02980692 |
Recruitment Status :
Completed
First Posted : December 2, 2016
Last Update Posted : February 6, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Active Psoriatic Arthritis | Drug: SUNPG1623 I Drug: SUNPG1623 II Drug: SUNPG1623 III Drug: SUNPG1623 IV Drug: PLACEBO | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 391 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2b Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Active Psoriatic Arthritis |
Actual Study Start Date : | May 17, 2017 |
Actual Primary Completion Date : | March 1, 2019 |
Actual Study Completion Date : | November 6, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: SUNPG1623 I
Short-term dose
|
Drug: SUNPG1623 I
injection |
Experimental: SUNPG1623 II
Mid-term dose
|
Drug: SUNPG1623 II
injection Drug: PLACEBO injection |
Experimental: SUNPG1623 dose III
Mid-term dose
|
Drug: SUNPG1623 III
injection Drug: PLACEBO injection |
Experimental: SUNPG1623 dose IV
Mid to long-term dose
|
Drug: SUNPG1623 IV
injection Drug: PLACEBO injection |
Placebo Comparator: Placebo
Mid to long-term dose
|
Drug: PLACEBO
injection |
- Proportion of subjects who achieve response [ Time Frame: Week 24 ]
- Adverse events [ Time Frame: Week 24 ]
- Proportion of subjects who achieve response [ Time Frame: Week 52 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject has provided written informed consent
- Subject is ≥ 18 years of age at time of Screening
- Subject must be on stable dose of NSAID for ≥ 4 weeks prior to initiation of IMP
- Subject has a negative evaluation for TB within 4 weeks before initiating IMP
Exclusion Criteria:
- Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pretreatment condition
- Subject has an active infection or history of infections
- Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease
- Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980692
United States, Ohio | |
SPARC Site 1 | |
Middleburg Heights, Ohio, United States, 44130 |
Responsible Party: | Sun Pharma Global FZE |
ClinicalTrials.gov Identifier: | NCT02980692 |
Other Study ID Numbers: |
CLR_16_23 |
First Posted: | December 2, 2016 Key Record Dates |
Last Update Posted: | February 6, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis |
Spondylitis Spinal Diseases Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases |