Long-term evaluation of TLL-018 for rheumatoid arthritis patients

An Open-label, Long-term Extension Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of TLL-018 in Patients With Rheumatoid Arthritis

This study is testing a medication called TLL-018 to see how safe and effective it is for adults with rheumatoid arthritis over a long period of time.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hangzhou Highlightll Pharmaceutical Co., Ltd (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06887127 on ClinicalTrials.gov

What this trial studies

This study is an open-label extension designed to assess the long-term safety, tolerability, and efficacy of TLL-018 in adults with rheumatoid arthritis who have previously participated in a randomized controlled trial. Participants will receive TLL-018 at a dosage of 20 mg twice daily for 78 weeks. The study includes a screening period, treatment period, and follow-up period, with regular assessments of safety and efficacy through various clinical evaluations and questionnaires. The aim is to gather comprehensive data on the drug's performance over an extended duration.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 who have completed the preceding TLL-018-301 study within the last three months.

Not a fit: Patients who experienced severe allergic reactions to TLL-018 during the previous study will not benefit from this trial.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term management of rheumatoid arthritis with TLL-018.

How similar studies have performed: Previous studies involving similar long-term evaluations of treatments for rheumatoid arthritis have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Subjects have completed TLL-018-301 study within 3 months;
* Age (at the time of consent):\>＝18 years of age, \<＝75 years of age;
* Female subjects of childbearing potential (WOCBP), who should not be pregnant or breastfeeding, should not enter the study until after pregnancy testing (e.g., HCG beta subunit-based monitoring);
* All subjects and their partners voluntarily use contraception as deemed effective by the investigator for at least 90 days from the first dose of the investigational drug to the last dose of the investigational drug (Appendix I); no sperm or egg donation is planned by the subject for at least 6 months from the screening period to the last dose of the investigational drug.
* Subjects can understand the informed consent form, volunteer to participate in the study and sign the informed consent form.

Exclusion Criteria:

* Subjects have had severe allergic reaction related to the investigational drug during the TLL-018-301 study;
* Subjects have had herpes zoster, a major cardiovascular event (MACE), thromboembolism, or lymphoproliferative disorders from the time of TLL-018-301 study to the screening of OLE study;
* Subjects have a clinically significant cardiovascular, respiratory, or any other serious and/or non-stable disease, and there is security risk for subjects to participate in this study judged by the investigator;
* Subjects have abnormal and clinically significant laboratory test values at screening;
* Subjects who have taken traditional Chinese medicines, csDMARDs, immunosuppressive drugs, potent opioids, and other JAK inhibitors (except the investigational drugs in TLL-018-301 study) within 1 week before taking the first dose of the investigational drug in OLE study;
* Subjects have treated with flunomide, any bDMARDs, interferon, and other injected immunosuppressive drugs from TLL-018-301 study to the screening of OLE study;
* Subjects who have received any live vaccine within 2 months prior to taking the first dose of the investigational drug or who plan to receive a live vaccine during the study;
* Subjects have had active tuberculosis infection without evidence of clinical cure; have suspected tuberculosis symptoms judged by the investigator; have latent tuberculosis infection (LTBI) but not received preventive treatment regimens within 3 years prior to screening or not completed a course of therapy.

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)

Conditions Rheumatoid Arthritis