A Study to Evaluate 608 in Patients With Ankylosing Spondylitis (AS)

Ankylosing Spondylitis Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Double Dummy，Placebo and Positive Controlled，Phase II Clinical Study to Evaluate the Efficacy and Safety of 608 in Patients With Ankylosing Spondylitis (AS)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06242652
• Other study ID #: SSGJ-608-AS-II-01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 19, 2024
• Est. completion date: June 15, 2025

Study information

• Verified date: February 2024
• Source: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Contact: Zhou Qing hong, BS
• Phone: +86 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 AS.

Description:

The purpose of this study is to demonstrate the clinical efficacy, safety and tolerability of 608 compared to placebo and positive drug in patients with AS.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: June 15, 2025
• Est. primary completion date: February 27, 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. Participant with a clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York criteria for AS.

3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4 and a Patient's Assessment of Total Back Pain score >= 4 based on a 0 - 10 numeric rating scale (NRS) at the Screening and Baseline visits.

4. If entering the study on concomitant NSAIDs for AS, participant must be on stable dose(s) for at least 2 weeks prior to the Baseline visit.

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• 608 Dose A
608 subcutaneous (SC) injection.
• 608 Dose B
608 subcutaneous (SC) injection.
• 608 Dose C
608 subcutaneous (SC) injection.
• Adalimumab
Adalimumab subcutaneous (SC) injection.
• Placebo
Placebo subcutaneous (SC) injection.

Locations

Country	Name	City	State
China	Site 01	Beijing	Beijing

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
Other	608 Concentration in Serum.	The concentration of 608 in Serum.	Up to 24 Weeks.
Primary	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.	Week 16.
Secondary	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.	Week 16.