NCT06222671

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 22, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

January 10, 2024

Last Update Submit

March 6, 2025

Conditions

Axial Spondyloarthritis

Keywords

non-radiographic axial spondyloarthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 20 Response

    From Baseline to the Week 16

  • 608 Concentration in Serum

    From Baseline to Week 24

Study Arms (3)

608 Dose A

EXPERIMENTAL

608 Dose A subcutaneous (SC) injection.

Drug: 608

608 Dose B

EXPERIMENTAL

608 Dose B subcutaneous (SC) injection.

Drug: 608

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous (SC) injection.

Drug: Placebo

Interventions

608DRUG

608 subcutaneous (SC) injection.

608 Dose A
PlaceboDRUG

Placebo subcutaneous (SC) injection.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Site 01

Beijing, Beijing Municipality, 100730, China

RECRUITING

Site 03

Beijing, Beijing Municipality, 100730, China

RECRUITING

Site 05

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

Site 02

Zhengzhou, Henan, 450052, China

RECRUITING

Site 04

Nanjing, Jiangsu, 210008, China

RECRUITING

Site 06

Shenzhen, Shenzhen, 518020, China

NOT YET RECRUITING

MeSH Terms

Conditions

Axial SpondyloarthritisNon-Radiographic Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Officials

  • Qinghong Zhou, BS

    Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

    STUDY DIRECTOR

  • Xiaofeng Zeng, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinghong Zhou, BS

CONTACT

18911301578zhouqinghong@3sbio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 25, 2024

Study Start

March 22, 2024

Primary Completion

September 22, 2025

Study Completion

November 30, 2025

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(6)