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

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)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Axial Spondyloarthritis
• Intervention / Treatment: Drug: Placebo; Drug: 608

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 Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qinghong Zhou, BS; Phone Number: 18911301578; Email: zhouqinghong@3sbio.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Site 01
      • Contact: Xiaofeng Zeng, MD; Phone Number: +86 13501069845; Email: Xiaofeng.zeng@cstar.org.cn
      • Principal Investigator: Xiaofeng Zeng, MD
    • Beijing, Beijing, China, 100730
      • Site 03
      • Contact: Li Cui, MD; Phone Number: +86 13611271262; Email: 13611271262@163.com
      • Principal Investigator: Li Cui, MD
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Site 05
      • Contact: Ling Tang, MD; Phone Number: +86 13896018063; Email: hopetang@163.com
      • Principal Investigator: Ling Tang, MD
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Site 02
      • Contact: Shenyun Liu, MD; Phone Number: +86 13837192659; Email: fccliusy2@zzu.edu.cn
      • Principal Investigator: Shenyun Liu, MD
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Site 04
      • Contact: Lingyun Sun, MD; Phone Number: +86 13705186409; Email: lingyunsun2012@163.com
      • Principal Investigator: Lingyun Sun, MD
  • Shenzhen
    • Shenzhen, Shenzhen, China, 518020
      • Site 06
      • Contact: Dongzhou Liu, MD; Phone Number: +86 13802257360; Email: liu_dz2001@sina.com
      • Principal Investigator: Dongzhou Liu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo subcutaneous (SC) injection.	Drug: Placebo; Placebo subcutaneous (SC) injection.
Experimental: 608 Dose A; 608 Dose A subcutaneous (SC) injection.	Drug: 608; 608 subcutaneous (SC) injection.
Experimental: 608 Dose B; 608 Dose B subcutaneous (SC) injection.	Drug: 608; 608 subcutaneous (SC) injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
608 Concentration in Serum	The concentration of 608 in Serum.	From Baseline to Week 24

Collaborators and Investigators

• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Investigators: Study Director: Qinghong Zhou, BS, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.; Principal Investigator: Xiaofeng Zeng, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 31, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Estimated): January 25, 2024

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: non-radiographic axial spondyloarthritis
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis
• Other Study ID Numbers: SSGJ-608-nr-axSpA-II-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No