Efficacy and Safety Study of SUNPG1622

Sun Pharma

Status and phase: Terminated; Phase 2

Conditions: Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis

Treatments: Drug: Placebo dose; Drug: SUNPG1622 I dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02980705

CLR_16_22

Details and patient eligibility

About

This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups, including a placebo group

SUNPG1622 I

Experimental group

Description:

SUNPG1622 I dose

Treatment:

Drug: SUNPG1622 I dose

Placebo

Placebo Comparator group

Description:

Placebo dose

Treatment:

Drug: Placebo dose