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

NCT06242652 | Active Not Recruiting Phase 2

• 1 other identifier: SSGJ-608-AS-II-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effect and safety of 608 in patients with AS.

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 16.

Secondary Outcomes (1)

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

  Week 16.

Other Outcomes (1)

• 608 Concentration in Serum.

  Up to 24 Weeks.

Study Arms (5)

608 Dose A

EXPERIMENTAL

608 Dose A subcutaneous (SC) injection.

Drug: 608 Dose A

608 Dose B

EXPERIMENTAL

608 Dose B subcutaneous (SC) injection.

Drug: 608 Dose B

608 Dose C

EXPERIMENTAL

608 Dose C subcutaneous (SC) injection.

Drug: 608 Dose C

Positive control group

ACTIVE COMPARATOR

Adalimumab subcutaneous (SC) injection.

Drug: Adalimumab

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous (SC) injection.

Drug: Placebo

Interventions

608 Dose A DRUG

608 subcutaneous (SC) injection.

Also known as: SSGJ-608 Dose A

608 Dose A

608 Dose B DRUG

608 subcutaneous (SC) injection.

Also known as: SSGJ-608 Dose B

608 Dose B

608 Dose C DRUG

608 subcutaneous (SC) injection.

Also known as: SSGJ-608 Dose C

608 Dose C

Adalimumab DRUG

Adalimumab subcutaneous (SC) injection.

Also known as: Humira

Positive control group

Placebo DRUG

Placebo subcutaneous (SC) injection.

Placebo

Eligibility Criteria

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

You may qualify if:

• Female and male patients at least 18 years of age at the time of screening.
• Participant with a clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York criteria for AS.
• 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.
• 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.

You may not qualify if:

• Patients with other uncontrolled active inflammatory diseases.
• Clinical laboratory tests and other tests that reveal abnormalities with clinical significance
• Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
• History of cancer.
• Known or suspected history of immunosuppression.

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (1)

Site 01

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 5, 2024
• Study Start: March 19, 2024
• Primary Completion: February 27, 2025
• Study Completion: June 15, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)