Back to resultsA Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Ankylosing Spondylitis
Primary Purpose
Ankylosing Spondylitis
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR0302
SHR0302 placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ankylosing Spondylitis
Eligibility Criteria
Inclusion Criteria:
- Provide signed informed consent.
- AS diagnosis consistent with the Modified New York Criteria for AS (1984);
- Participant must have baseline disease activity as defined by having a 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.
- Participant has had an inadequate response to at least two Nonsteroidal Anti-inflammatory Drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
- If subjects are taking permitted csDMARDs or low-dose corticosteroid orally at baseline , the stable doses should have lasted for more than 4 weeks already.
- BMI ≥18 kg/m2
Exclusion Criteria:
- Pregnant women or refuse to receive contraception during the study.
- Lab abnormality within 4 weeks of randomization as follows: WBC count <3.0×10^9/L；neutrophil count<1.5×10^9/L;hemoglobin level<90.0 g/L ; platelet count <100×10^9/L; AST or ALT levels greater than the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
- History of other autoimmune diseases ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
- Previous treatment with JAK inhibitor or cytotoxic drugs; bDMARDs within 6 months of randomization; other strong immunosuppressants within 6 months of randomization.
Sites / Locations
- Zhanguo Li
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
SHR0302 dose1
SHR0302 dose2
SHR0302 dose3
Placebo
Arm Description
SHR0302 dose1 for 24 weeks
SHR0302 dose2 for 24 weeks
SHR0302 dose3 for 24 weeks
Placebo for 12 weeks
Outcomes
Primary Outcome Measures
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 12.
ASAS20 is defined as a >= 20% improvement and an absolute improvement of >= 1 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no deterioration in the remaining domain (where deterioration is defined as a worsening of >= 20% and a net worsening of >= 1 unit [on a scale of 0 to 10])
Secondary Outcome Measures
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 24.
ASAS20 is defined as a >= 20% improvement and an absolute improvement of >= 1 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no deterioration in the remaining domain (where deterioration is defined as a worsening of >= 20% and a net worsening of >= 1 unit [on a scale of 0 to 10]) at Week 24.
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response at Week 12 and Week 24.
ASAS40 is defined as a >= 40% improvement and an absolute improvement of ≥ 2 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no worsening at all in the remaining domain.
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 5/6 response at Week 12 and Week 24.
ASAS5/6 is defined as an improvement of at least 20 % in at least five of these six domains (patient global, pain, function, inflammation, CRP, and spinal mobility).
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
BASDAI is a commonly used measure to define disease activity levels in axSpA patients. It consists of 6 questions on a 0 through 10 numeric rating scale (NRS) (0 being no problem and 10 being the worst problem) pertaining to the 5 major symptoms of AS: Fatigue, Spinal pain, Joint pain/swelling, Areas of localized tenderness, Morning stiffness duration, and Morning stiffness severity.
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12 and Week 24.
The BASFI is a validated patient reported outcome (PRO) instrument for use in the AS patient population. It consists of 10 items measured on a 0 to 10 NRS, which assesses the ability to perform activities known to be problematic to AS patients such as dressing, bending, reaching, turning, and climbing steps. The total scores range from 0 to 10.
Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12 and Week 24.
The BASMI will be conducted at the visits specified to evaluate spinal mobility in a participan.
Change from baseline in Short-Form-36-Health Survey (SF-36) at Week 12 and Week 24.
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=no functioning, 100=highest level of functioning). Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.
Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 12 and Week 24.
The ASQoL is an 18-item axSpA-specific Quality of Life (QoL) PRO measure validated in the AS patient population. Concepts measured include activities of daily life, emotional functioning, pain, fatigue, and sleep problems. Each item on ASQoL is given a score of "1" or "0," where a score of "1" is given when an item is affirmed indicating adverse QoL. Total scores can range from 0 (good QoL) to 18 (poor QoL).
Full Information
NCT ID
NCT04481139
First Posted
July 15, 2020
Last Updated
July 26, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04481139
Brief Title
A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Ankylosing Spondylitis
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Adaptive Seamless Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Ankylosing Spondylitis Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
May 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with active ankylosing spondylitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
504 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SHR0302 dose1
Arm Type
Experimental
Arm Description
SHR0302 dose1 for 24 weeks
Arm Title
SHR0302 dose2
Arm Type
Experimental
Arm Description
SHR0302 dose2 for 24 weeks
Arm Title
SHR0302 dose3
Arm Type
Experimental
Arm Description
SHR0302 dose3 for 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 12 weeks
Intervention Type
Drug
Intervention Name(s)
SHR0302
Intervention Description
SHR0302, oral, once daily
Intervention Type
Drug
Intervention Name(s)
SHR0302 placebo
Intervention Description
SHR0302 placebo, oral, once daily
Primary Outcome Measure Information:
Title
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 12.
Description
ASAS20 is defined as a >= 20% improvement and an absolute improvement of >= 1 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no deterioration in the remaining domain (where deterioration is defined as a worsening of >= 20% and a net worsening of >= 1 unit [on a scale of 0 to 10])
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 24.
Description
ASAS20 is defined as a >= 20% improvement and an absolute improvement of >= 1 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no deterioration in the remaining domain (where deterioration is defined as a worsening of >= 20% and a net worsening of >= 1 unit [on a scale of 0 to 10]) at Week 24.
Time Frame
Week 24
Title
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response at Week 12 and Week 24.
Description
ASAS40 is defined as a >= 40% improvement and an absolute improvement of ≥ 2 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no worsening at all in the remaining domain.
Time Frame
Week 12 and Week 24
Title
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 5/6 response at Week 12 and Week 24.
Description
ASAS5/6 is defined as an improvement of at least 20 % in at least five of these six domains (patient global, pain, function, inflammation, CRP, and spinal mobility).
Time Frame
Week 12 and Week 24
Title
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
BASDAI is a commonly used measure to define disease activity levels in axSpA patients. It consists of 6 questions on a 0 through 10 numeric rating scale (NRS) (0 being no problem and 10 being the worst problem) pertaining to the 5 major symptoms of AS: Fatigue, Spinal pain, Joint pain/swelling, Areas of localized tenderness, Morning stiffness duration, and Morning stiffness severity.
Time Frame
Week 12 and Week 24
Title
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12 and Week 24.
Description
The BASFI is a validated patient reported outcome (PRO) instrument for use in the AS patient population. It consists of 10 items measured on a 0 to 10 NRS, which assesses the ability to perform activities known to be problematic to AS patients such as dressing, bending, reaching, turning, and climbing steps. The total scores range from 0 to 10.
Time Frame
Week 12 and Week 24
Title
Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12 and Week 24.
Description
The BASMI will be conducted at the visits specified to evaluate spinal mobility in a participan.
Time Frame
Week 12 and Week 24
Title
Change from baseline in Short-Form-36-Health Survey (SF-36) at Week 12 and Week 24.
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=no functioning, 100=highest level of functioning). Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.
Time Frame
Week 12 and Week 24
Title
Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 12 and Week 24.
Description
The ASQoL is an 18-item axSpA-specific Quality of Life (QoL) PRO measure validated in the AS patient population. Concepts measured include activities of daily life, emotional functioning, pain, fatigue, and sleep problems. Each item on ASQoL is given a score of "1" or "0," where a score of "1" is given when an item is affirmed indicating adverse QoL. Total scores can range from 0 (good QoL) to 18 (poor QoL).
Time Frame
Week 12 and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provide signed informed consent.
AS diagnosis consistent with the Modified New York Criteria for AS (1984);
Participant must have baseline disease activity as defined by having a 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.
Participant has had an inadequate response to at least two Nonsteroidal Anti-inflammatory Drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
If subjects are taking permitted csDMARDs or low-dose corticosteroid orally at baseline , the stable doses should have lasted for more than 4 weeks already.
BMI ≥18 kg/m2
Exclusion Criteria:
Pregnant women or refuse to receive contraception during the study.
Lab abnormality within 4 weeks of randomization as follows: WBC count <3.0×10^9/L；neutrophil count<1.5×10^9/L;hemoglobin level<90.0 g/L ; platelet count <100×10^9/L; AST or ALT levels greater than the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
History of other autoimmune diseases ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
Previous treatment with JAK inhibitor or cytotoxic drugs; bDMARDs within 6 months of randomization; other strong immunosuppressants within 6 months of randomization.
Facility Information:
Facility Name
Zhanguo Li
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Ankylosing Spondylitis
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