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Recruiting NCT06222671

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

Phase II Interventional Axial Spondyloarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 608, 608, Placebo.
Who it may be relevant to
Registry conditions: Axial Spondyloarthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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

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.

Interventions

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

Primary outcome measures

  • The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response [Time frame: From Baseline to Week 16]
Secondary outcome measures (2)
  • The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 20 Response [Time frame: From Baseline to the Week 16]
  • 608 Concentration in Serum [Time frame: From Baseline to Week 24]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 6 centers
  • Site 01 — Beijing
  • Site 03 — Beijing
  • Site 05 — Chongqing
  • Site 02 — Zhengzhou
  • Site 04 — Nanjing
  • Site 06 — Shenzhen

Identifiers

NCT: NCT06222671 · SSGJ-608-nr-axSpA-II-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗