A Long-term Extension Clinical Study of TLL-018 in Patients With Rheumatoid Arthritis

Launched by HANGZHOU HIGHLIGHTLL PHARMACEUTICAL CO., LTD · Mar 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called TLL-018, aimed at understanding its long-term safety and effectiveness in patients with rheumatoid arthritis (RA). This study is for people who have previously participated in another trial of TLL-018 and are now looking to see how well it works for a longer period. The trial is currently recruiting participants aged 18 to 75, including both men and women.

To qualify for the study, participants must have completed the earlier trial with TLL-018 within the last three months and should not have serious health issues that could make participation unsafe. Women who can become pregnant must not be pregnant or breastfeeding and will need to undergo pregnancy testing before joining. Participants can expect to receive TLL-018 and will be monitored for any side effects or changes in their condition throughout the study. Overall, this trial aims to provide more information about how TLL-018 can help manage rheumatoid arthritis over time.

Gender

ALL

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.