Interleukin-17 (IL-17) Inhibitor in Combination With Tumor Necrosis Factor α (TNFα )Inhibitor for the Treatment of Ankylosing Spondylitis

NCT06833112 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 2024114K
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the efficacy and safety of adalimumab in combination with secukinumab for the treatment of ankylosing spondylitis.

Conditions

Ankylosing Spondylitis

Keywords

ankylosing spondylitis; Secukinumab; adalimumab

Outcome Measures

Primary Outcomes (4)

• Assessment of SpondyloArthritis International Society 40 (ASAS 40)

  Proportion of subjects achieving ASAS 40 at Week 52. ASAS 40 is a response criterion used to evaluate the effectiveness of treatments in patients with ankylosing spondylitis. It measures the percentage of patients who achieve at least a 40% improvement in disease activity. Key Components of ASAS40: * Patient Global Assessment:Patient's overall assessment of disease activity * Pain: Assessment of spinal pain. * Function: Measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). * Inflammation: Based on morning stiffness severity and duration. Calculation: A patient is considered an ASAS40 responder if they achieve at least a 40% improvement or an absolute improvement of ≥2 units (on a 0-10 scale) in at least 3 out of 4 domains, with no worsening in the remaining domain.

  week 52

• ASAS40

  1\. Proportion of subjects achieving ASAS 40 at Week 104. ASAS 40 is a response criterion used to evaluate the effectiveness of treatments in patients with ankylosing spondylitis. It measures the percentage of patients who achieve at least a 40% improvement in disease activity. Key Components of ASAS40: * Patient Global Assessment:Patient's overall assessment of disease activity * Pain: Assessment of spinal pain. * Function: Measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). * Inflammation: Based on morning stiffness severity and duration. Calculation: A patient is considered an ASAS40 responder if they achieve at least a 40% improvement or an absolute improvement of ≥2 units (on a 0-10 scale) in at least 3 out of 4 domains, with no worsening in the remaining domain.

  week 104

• Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS)

  The mSASSS is a method used to assess spinal damage and function in patients with ankylosing spondylitis. The assessment Items includes: * Vertebral Scoring: It evaluates the morphology of each vertebra from T1 to L5. Each vertebra is scored from 0 to 3 based on the presence and degree of squaring, erosions, and syndesmophytes. For example, 0 means normal vertebra, and 3 indicates severe structural changes. * Intervertebral Disc Scoring: The intervertebral discs between the vertebrae are also assessed. The score ranges from 0 to 2, depending on the presence and extent of disc space narrowing and bridging syndesmophytes. Total Score Calculation: The scores of all vertebrae and intervertebral discs are summed up to obtain the mSASSS total score. The higher the score, the more severe the spinal damage.

  week 104

• Spondyloarthritis Research Consortium of Canada (SPARCC)

  The SPARCC assessment method is a valuable tool in the field of spondyloarthritis research and diagnosis. The assessment Items include: * Sacroiliac Joint Assessment: It evaluates the sacroiliac joints using magnetic resonance imaging (MRI). The assessment includes aspects such as bone marrow edema, erosion, and fatty infiltration in the sacroiliac joints. Each feature is scored based on its severity and extent. * Spinal Assessment: For the spine, SPARCC also uses MRI to assess inflammation. It focuses on detecting signs like vertebral corner inflammation (enthesitis) and discitis. Similar to the sacroiliac joint assessment, specific features are scored according to their characteristics. Scoring System: The total SPARCC score is obtained by summing up the scores of different items. Higher scores indicate more severe inflammation and greater disease activity.

  week 104

Secondary Outcomes (13)

• Assessment of SpondyloArthritis International Society 20 (ASAS20)

  week 12, week 24, week 52

• Assessment of SpondyloArthritis International Society 5/6 (ASAS5/6)

  week 12, week 24, week 52

• Assessment in Ankylosing Spondylitis international Society Partial Release (ASAS PR)

  week 12, week 24, week 52

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50

  week 12, week 24, week 52

• BASDAI

  week 12, week 24, week 52

Study Arms (1)

treatment group

EXPERIMENTAL

The subjects were treated with adalimumab (HS016) in combination with secukinumab

Drug: Secukinumab; Drug: Adalimumab

Interventions

Secukinumab DRUG

The subjects were treated with secukinumab for 104 weeks. Secukinumab:150mg，q8w，subcutaneous injection.

treatment group

Adalimumab DRUG

The subjects were treated with adalimumab for 104 weeks. adalimumab: 40mg，q4w，subcutaneous injection.

treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female at least 18 years old;
• diagnosed with AS according to the 1984 New York Modified Criteria;
• Poor response after at least 2 NSAIDs (cumulative treatment ≥ 4 weeks), or contraindication or intolerance to NSAIDs therapy;
• BASDAI score of ≥ 4 and total back pain VAS score of ≥ 4 at baseline;
• Subjects who need to take NSAIDs (including COX-1 or COX-2 inhibitors) as established treatment for AS, and the NSAIDs should be on a stable dose for at least 2 weeks (inclusive) before screening and the dose is expected to be stable during the study;
• Voluntary treatment with adalimumab and secukinumab;
• Appropriate contraceptive measures for women of childbearing age;
• without other rheumatic diseases.
• Able to understand study requirements, provide written informed consent, and comply with trial protocol procedures (including required visits)

You may not qualify if:

• With unstable vital signs, coma, mental and cognitive impairment;
• Patients with severe systemic diseases and other serious chronic diseases;
• Pregnant or lactating patients;
• History of malignant tumor in the past 5 years;
• Positive test for the following infection markers: human immunodeficiency virus (HIV), hepatitis B, hepatitis C, syphilis antibody;
• Patients with active or recurrent history of infection; With active tuberculosis or have a history of active tuberculosis in the past;
• Moderate to severe heart failure (New York Heart Association grade 3-4);
• Allergic to any of the components of adalimumab (HS016) or secukinumab;
• Subjects who are participating in clinical research of other drugs;
• In addition to the above, the investigator judged that there are other reasons that are not suitable for participating in this clinical study.

Sponsors & Collaborators

• The Affiliated Hospital Of Guizhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550002, China

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

secukinumab; Adalimumab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jiashun Zeng, Medical Doctor

  The Affiliated Hospital Of Guizhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiashun Zeng, Medical Doctor

CONTACT

13984846802; zengjiashun@sina.com

Pengjia Wu, Master

CONTACT

15085969933; 1015066791@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 18, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)