A Study to Evaluate 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA)

Axial Spondyloarthritis Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of 608 in Patients With Non-radiographic Axial Spondyloarthritis (Nr-axSpA)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06222671
• Other study ID #: SSGJ-608-nr-axSpA-II-01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 31, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: January 2024
• Source: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Contact: Qinghong Zhou, BS
• Phone: 18911301578
• Email: zhouqinghong[@]3sbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Non-Radiographic Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis

Intervention

Drug:
• 608
608 subcutaneous (SC) injection.
• 608
608 subcutaneous (SC) injection.
• Placebo
Placebo subcutaneous (SC) injection.

Locations

Country	Name	City	State
China	Site 01	Beijing	Beijing
China	Site 03	Beijing	Beijing
China	Site 05	Chongqing	Chongqing
China	Site 04	Nanjing	Jiangsu
China	Site 06	Shenzhen	Shenzhen
China	Site 02	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response	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.	From Baseline to Week 16
Secondary	The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 20 Response	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.	From Baseline to the Week 16
Secondary	608 Concentration in Serum	The concentration of 608 in Serum.	From Baseline to Week 24