A Study to Evaluate 608 in Patients with Non- Radiographic Axial Spondyloarthritis (nr-axSpA)

Phase 2

Recruiting

• Conditions: Axial Spondyloarthritis
• Interventions: Drug: 608; Drug: Placebo

• Registration Number: NCT06222671
• Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-24
• Study First Posted: 2024-01-25
• Study Start: 2024-03-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-09-22
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
608 Dose A	608	608 Dose A subcutaneous (SC) injection.
Placebo	Placebo	Placebo subcutaneous (SC) injection.
608 Dose B	608	608 Dose B subcutaneous (SC) injection.

Primary Outcome Measures

Name	Time	Method
The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response	From Baseline to Week 16	Assessment of Spondylo Arthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a NRS; 2. Patient's assessment of back pain, measured on a NRS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by NRS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by NRS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).; ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the NRS signifies higher severity.

Secondary Outcome Measures

Name	Time	Method
608 Concentration in Serum	From Baseline to Week 24	The concentration of 608 in Serum.
The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 20 Response	From Baseline to the Week 16	Assessment of Spondylo Arthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a NRS; 2. Patient's assessment of back pain, measured on a NRS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by NRS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by NRS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).; ASAS 20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain. A higher score on the NRS signifies higher severity.

Trial Locations

Locations (6)

Site 01; 🇨🇳 Beijing, Beijing, China

Site 03; 🇨🇳 Beijing, Beijing, China

Site 05; 🇨🇳 Chongqing, Chongqing, China

Site 02; 🇨🇳 Zhengzhou, Henan, China

Site 04; 🇨🇳 Nanjing, Jiangsu, China

Site 06; 🇨🇳 Shenzhen, Shenzhen, China