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

NCT06887127 | Recruiting Phase 3

• 1 other identifier: TLL-018-304
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to evaluate the long-term safety, tolerability, and efficacy of TLL-018 in patients with rheumatoid arthritis (RA) who have completed a preceding randomized controlled trial with TLL-018.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Number of occurrences and Percentage of Participants with AEs and SAEs

  Evaluation includes vital signs, physical examination, ECG examination, laboratory tests, AE, SAE, etc.

  At Weeks 6, 12, 24, 36, 48, 60, 72, 78

Secondary Outcomes (14)

• Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time

  At Weeks 12, 24, 36, 48, 60, 72, 78

• Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time

  At Weeks 12, 24, 36, 48, 60, 72, 78

• Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time

  At Weeks 12, 24, 36, 48, 60, 72, 78

• Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time

  At Weeks 12, 24, 36, 48, 60, 72, 78

• Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time

  At Weeks 12, 24, 36, 48, 60, 72, 78

Study Arms (1)

TLL-018

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.

Drug: TLL-018

Interventions

TLL-018 DRUG

TLL-018 20 mg BID for 78 weeks

TLL-018

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Highlightll Pharmaceutical Co., Ltd: lead

Study Sites (1)

Peking Union Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100022, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)