Axial SpondyloarthritisPhase 2NCT06222671
A Study to Evaluate 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA)
A Phase 2 study testing 608 in people with Axial Spondyloarthritis, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 6 sites in China.
Trial summary
This study will evaluate the effect and safety of 608 in patients with nr-axSpA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- 608
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 6 sitesChina
- Study dates
- 22 Mar 2024to 30 Nov 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male patients at least 18 years of age at the time of screening.
- Diagnosis of axial spondyloarthritis according to Ankylosing Spondylo Arthritis International Society (ASAS) axial spondyloarthritis criteria
- Objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
- Total back pain as measured by NRS ≥ 4 at baseline
Who cannot join
- Patients with other uncontrolled active inflammatory diseases.
- Clinical laboratory tests and other tests that reveal abnormalities with clinical significance
- Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
- History of cancer.
- Known or suspected history of immunosuppression.
- Known with allergic or intolerant to mometasone furoate spray or 608/placebo.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Site 01
Beijing, Beijing Municipality, 100730
Xiaofeng Zeng, MD, +86 13501069845, Xiaofeng.zeng@cstar.org.cn
Xiaofeng Zeng, MD
- Recruiting
Site 03
Beijing, Beijing Municipality, 100730
Li Cui, MD, +86 13611271262, 13611271262@163.com
Li Cui, MD
- Recruiting
Site 05
Chongqing, Chongqing Municipality, 400010
Ling Tang, MD, +86 13896018063, hopetang@163.com
Ling Tang, MD
- Recruiting
Site 04
Nanjing, Jiangsu, 210008
Lingyun Sun, MD, +86 13705186409, lingyunsun2012@163.com
Lingyun Sun, MD
- Not yet recruiting
Site 06
Shenzhen, Shenzhen, 518020
Dongzhou Liu, MD, +86 13802257360, liu_dz2001@sina.com
Dongzhou Liu, MD
- Recruiting
Site 02
Zhengzhou, Henan, 450052
Shenyun Liu, MD, +86 13837192659, fccliusy2@zzu.edu.cn
Shenyun Liu, MD
About this study
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)
This study will evaluate the effect and safety of 608 in patients with nr-axSpA.
Read the 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.
- Conditions
- Axial Spondyloarthritis
- Being tested
- 608, Placebo
- Keywords
- non-radiographic axial spondyloarthritis
- Medical subject headings
- Axial Spondyloarthritis, Non-Radiographic Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
608Drug
608 subcutaneous (SC) injection.
608Drug
608 subcutaneous (SC) injection.
PlaceboDrug
Placebo subcutaneous (SC) injection.
| Study group | Role | What they receive |
|---|---|---|
| 608 Dose A | Experimental | 608 Dose A subcutaneous (SC) injection. Receives: Drug: 608 |
| 608 Dose B | Experimental | 608 Dose B subcutaneous (SC) injection. Receives: Drug: 608 |
| Placebo | Placebo comparator | Placebo subcutaneous (SC) injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Baseline to Week 16
Secondary outcomes (2)
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.
Measured: From Baseline to the Week 16
608 Concentration in Serum
The concentration of 608 in Serum.
Measured: From Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start22 Mar 2024
- Primary completion22 Sep 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qinghong Zhou, BS, Study director, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Xiaofeng Zeng, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222671
- Sponsor's protocol ID
- SSGJ-608-nr-axSpA-II-01
- Status last verified
- Mar 2025
- First submitted
- 10 Jan 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No