Ankylosing Spondylitis
Conditions
Brief summary
This study will evaluate the effect and safety of 608 in patients with AS.
Detailed description
The purpose of this study is to demonstrate the clinical efficacy, safety and tolerability of 608 compared to placebo and positive drug in patients with AS.
Interventions
DRUG608 Dose A
608 subcutaneous (SC) injection.
DRUG608 Dose B
608 subcutaneous (SC) injection.
DRUG608 Dose C
608 subcutaneous (SC) injection.
DRUGAdalimumab
Adalimumab subcutaneous (SC) injection.
DRUGPlacebo
Placebo subcutaneous (SC) injection.
Sponsors
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 20 Response. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 608 Concentration in Serum. | Up to 24 Weeks. | The concentration of 608 in Serum. |
Countries
China
Outcome results
None listed