A Study to Evaluate the Efficacy and Safty of 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA)

Sunshine Guojian Pharmaceutical

Status and phase: Begins enrollment this month; Phase 3

Conditions: Axial Spondyloarthritis, Non-Radiographic

Treatments: Drug: Placebo; Drug: 608

Study type: Interventional

Funder types: Industry

Identifiers

NCT07349329

SSGJ-608-nr-axSpA-III-01

Details and patient eligibility

About

This study will evaluate the efficacy and safety of 608 in patients with nr-axSpA.

Full description

The purpose of this study is to demonstrate the clinical efficacy, safety of 608 compared to placebo in patients with nr-axSpA.

Enrollment: 380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female and male patients at least 18 years of age at the time of screening.
2. Diagnosis of axial spondyloarthritis according to Ankylosing Spondylo Arthritis International Society (ASAS) axial spondyloarthritis criteria
3. Objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
4. Total back pain as measured by NRS ≥ 4 at baseline

Exclusion criteria

1. Patients with other uncontrolled active inflammatory diseases.
2. Clinical laboratory tests and other tests that reveal abnormalities with clinical significance
3. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
4. History of cancer.
5. Known or suspected history of immunosuppression.
6. Known with allergic or intolerant to mometasone furoate spray or 608/placebo.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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380 participants in 2 patient groups, including a placebo group

608

Experimental group

Description:

608 subcutaneous (SC) injection.

Treatment:

Drug: 608

Placebo

Placebo Comparator group

Description:

Placebo subcutaneous (SC) injection.

Treatment:

Drug: Placebo