A Study to Evaluate 608 in Patients With Non- Radiographi... | NCT06222671

NCT06222671

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
608	Drug	608 subcutaneous (SC) injection.	608 Dose A
608

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.

Eligibility Module

Name	Affiliation	Role
Qinghong Zhou, BS	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	Study Director
Xiaofeng Zeng, MD	Peking Union Medical College Hospital	Principal Investigator

ID	Term
D000089183	Axial Spondyloarthritis
D000089202	Non-Radiographic Axial Spondyloarthritis