Active — Not RecruitingPhase 2

A Phase II Trial of SHR-3045 Injection in Patients With Rheumatoid Arthritis

China30 participantsStarted 2026-01-19

Plain-language summary

This study is ongoing to explore the efficacy and safety of different strengths of SHR-3045 injection in moderate to severe active rheumatoid arthritis.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Voluntarily sign the informed consent form before the start of activities related to this study, be able to understand the procedures and methods of this study, and be willing to strictly follow the clinical research protocol to complete this study.
. Age 18 to 75 years (including both ends) at the time of signing the informed consent form, with no gender restrictions.
. Suffer from moderate to severe active rheumatoid arthritis (RA).
. Have shown an inadequate response or intolerance to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD), biologic disease-modifying antirheumatic drug (bDMARD), or targeted synthetic disease-modifying antirheumatic drug (tsDMARD) during screening.
. Have a body mass index (BMI = weight (kg) / height² (m²)) of ≥ 18 kg/m² at the time of screening.

Exclusion criteria

. General conditions: (1) Pregnant or breastfeeding women; (2) Have not used or refused to use the contraceptive measures specified in the study protocol within 6 months after the last intake of medication (except for subjects or partners who are infertile); (3) Drug abuse; (4) The researcher judges that there are factors affecting the safety and efficacy evaluation of the study drug.
. Within 4 weeks prior to the random visit, the following conditions are identified in laboratory tests and 12-lead electrocardiogram (ECG): (1) White blood cell count \< 3.0 × 10⁹/L; (2) Neutrophil count \< 1.5 × 10⁹/L; (3) Hemoglobin \< 90.0 g/L; (4) Platelet count \< 100 × 10⁹/L; (5) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 times the upper limit of normal (ULN), or total bilirubin (T-BIL) \> 1.5 times the upper limit of normal (ULN); (6) Estimated glomerular filtration rate (eGFR) calculated by the Modification of Diet in Renal Disease (MDRD) formula \< 60 mL/min/1.73 m² (see details in Section 13.4 of the Appendix); (7) Glycated hemoglobin (HbA1c) ≥ 8.0%; (8) Positive anti-hepatitis C virus (HCV) antibody with HCV RNA exceeding the upper limit of normal, positive human immunodeficiency virus (HIV) antibody, or positive syphilis antibody; (9) 12-lead ECG indicates clinically significant abnormalities that may affect the safety of the subject, including but not limited to acute myocardial ischemia, myocardial infarction, severe arrhythmia, or significant QTc prolongation (QTc \> 500 ms).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The percentage of subjects who achieved a 20% improvement in the American College of Rheumatology Rheumatoid Arthritis (RA) disease activity assessment core set.

Timeframe: After 14 weeks of treatment.

Trial details

NCT IDNCT07233655

SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-21

View on ClinicalTrials.gov More Moderate to Severe Active Rheumatoid Arthritis trials