Trials / Unknown
UnknownNCT06242652
A Study to Evaluate 608 in Patients with Ankylosing Spondylitis (AS)
A Multicenter, Randomized, Double-blind, Double Dummy，placebo and Positive Controlled，phase II Clinical Study to Evaluate the Efficacy and Safety of 608 in Patients with Ankylosing Spondylitis (AS)
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the effect and safety of 608 in patients with AS.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 608 Dose A | 608 subcutaneous (SC) injection. |
| DRUG | 608 Dose B | 608 subcutaneous (SC) injection. |
| DRUG | 608 Dose C | 608 subcutaneous (SC) injection. |
| DRUG | Adalimumab | Adalimumab subcutaneous (SC) injection. |
| DRUG | Placebo | Placebo subcutaneous (SC) injection. |
Timeline
- Start date
- 2024-03-19
- Primary completion
- 2025-02-27
- Completion
- 2025-06-15
- First posted
- 2024-02-05
- Last updated
- 2024-10-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06242652. Inclusion in this directory is not an endorsement.