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

Sunshine Guojian Pharmaceutical

Status and phase: Active, not recruiting; Phase 2

Conditions: Ankylosing Spondylitis

Treatments: Drug: Placebo; Drug: 608 Dose A; Drug: 608 Dose C; Drug: 608 Dose B; Drug: Adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06242652

SSGJ-608-AS-II-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 5 patient groups, including a placebo group

608 Dose A

Experimental group

Description:

608 Dose A subcutaneous (SC) injection.

Treatment:

Drug: 608 Dose A

608 Dose B

Experimental group

Description:

608 Dose B subcutaneous (SC) injection.

Treatment:

Drug: 608 Dose B

608 Dose C

Experimental group

Description:

608 Dose C subcutaneous (SC) injection.

Treatment:

Drug: 608 Dose C

Positive control group

Active Comparator group

Description:

Adalimumab subcutaneous (SC) injection.

Treatment:

Drug: Adalimumab

Placebo

Placebo Comparator group

Description:

Placebo subcutaneous (SC) injection.

Treatment:

Drug: Placebo