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

NCT06242652
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Phase
Phase 2
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Recruitment status
Unknown
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Participants
250
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Lead sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
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Start date
2024-03-19
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Number of sites
1
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Summary
This study will evaluate the effect and safety of 608 in patients with AS.
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Short title
A Study to Evaluate 608 in Patients with Ankylosing Spondylitis (AS)
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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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Unknown
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Phase
Phase 2
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Study type
Interventional
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Completion date
2025-06-15
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First posted
2024-02-05
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Registry last updated
2024-10-23
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Primary completion date
2025-02-27
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Start date
2024-03-19
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Participants
250
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Participant count basis
Estimated
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Planned participants
250
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Protocol amendments
1
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06242652
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ClinicalTrials.gov ID
NCT06242652
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: Week 16.

    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.

  1. The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response.

    Timeframe: Week 16.

    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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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.

  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.
Sources for eligibility
clinicaltrials.gov

  • Site 01Beijing, China
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)