Efficacy and Safety Study of SUNPG1623

Sun Pharma

Status and phase: Completed; Phase 2

Conditions: Active Psoriatic Arthritis

Treatments: Drug: SUNPG1623 I; Drug: SUNPG1623 II; Drug: PLACEBO; Drug: SUNPG1623 IV; Drug: SUNPG1623 III

Study type: Interventional

Funder types: Industry

Identifiers

NCT02980692

CLR_16_23

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to demonstrate the safety and efficacy of SUNPG1623

Enrollment: 391 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Subject has a diagnosis of PsA (by the Classification of Psoriatic Arthritis [CASPAR] criteria) with symptoms present for at least 6 months.
• Subject has ≥ 3 tender and ≥ 3 swollen joints at Screening and Baseline.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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391 participants in 5 patient groups, including a placebo group

SUNPG1623 dose I

Experimental group

Description:

low range dose

Treatment:

Drug: SUNPG1623 I

SUNPG1623 dose II

Experimental group

Description:

mid range dose

Treatment:

Drug: SUNPG1623 II

Drug: PLACEBO

SUNPG1623 dose III

Experimental group

Description:

mid range dose

Treatment:

Drug: PLACEBO

Drug: SUNPG1623 III

SUNPG1623 dose IV

Experimental group

Description:

mid range dose to high dose

Treatment:

Drug: SUNPG1623 IV

Drug: PLACEBO

Placebo

Placebo Comparator group

Description:

mid range dose to high dose

Treatment:

Drug: PLACEBO