Trials / Recruiting
RecruitingNCT07261644
A Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis(AS)
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis (AS)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy and safety of 608 in patients with AS.
Detailed description
The purpose of this trial is to demonstrate the clinical efficacy at week 16; and to demonstrate safety and tolerability of 608 compared to placebo in patients with ankylosing spondylitis at week 16 and long term safety up to Week 60.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 608 dose | 608 subcutaneous (SC) injection. |
| DRUG | Placebo | Placebo subcutaneous (SC) injection. |
Timeline
- Start date
- 2025-11-07
- Primary completion
- 2027-01-14
- Completion
- 2027-11-18
- First posted
- 2025-12-03
- Last updated
- 2025-12-10
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07261644. Inclusion in this directory is not an endorsement.