Recruiting

TLL-018 Safety and Efficacy in Rheumatoid Arthritis

What is being tested

TLL-018

Drug

Who is being recruted

Arthritis+6

+ Arthritis, Rheumatoid

+ Autoimmune Diseases

From 18 to 75 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: March 2025

See protocol details

Summary

Principal SponsorHangzhou Highlightll Pharmaceutical Co., Ltd

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 10, 2025

Actual date on which the first participant was enrolled.

This study is designed to further examine the long-term effects and safety of a drug called TLL-018 in adults who have rheumatoid arthritis (RA). These patients have already participated in a previous study with TLL-018. RA is a chronic condition that causes pain and swelling in the joints, and this study aims to see if TLL-018 can effectively manage these symptoms over an extended period. The study is important because it could provide insights into the long-term use of TLL-018, potentially offering a new treatment option for those living with RA. Participants in the study will take TLL-018 as a pill, 20 mg twice a day, for 78 weeks. The study will check the safety of the drug through regular physical exams, lab tests, and monitoring for any side effects at various intervals during the treatment. To evaluate how well the drug works, assessments will be done on joint health, patient health questionnaires, and other measures of RA symptoms at several points throughout the study. This helps to determine the drug's effectiveness in improving the quality of life for those with RA.

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

NCT06887127

Principal SponsorHangzhou Highlightll Pharmaceutical Co., Ltd

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

350 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisArthritis, RheumatoidAutoimmune DiseasesConnective Tissue DiseasesImmune System DiseasesJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSkin and Connective Tissue Diseases

Criteria

5 inclusion criteria required to participate

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.

Show More Criteria

8 exclusion criteria prevent from participating

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;

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants received a two-stage treatment period in Study TLL-018-301, with treatment of 24 weeks of TLL-018 20 mg BID or tofacitinib 5 mg BID in Stage 1. In Stage 2, the participants with tofacitinib who didn't achieve ACR50 were transferred to TLL-018, and other participants maintained the original treatment. Upon completion of Study TLL-018-301, qualified participants can enter the OLE study, and all participants will receive TLL-018 20 mg BID, i.e., 2 tablets of TLL-018 10 mg orally twice daily, for 78 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Peking Union Hospital, Chinese Academy of Medical Sciences

Beijing, ChinaOpen Peking Union Hospital, Chinese Academy of Medical Sciences in Google Maps

Recruiting

One Study Center