New arthritis drug TLL-018 moves to Long-Term safety check in 350 patients
NCT ID NCT06887127
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is checking the long-term safety and effectiveness of an experimental drug called TLL-018 for people with rheumatoid arthritis. It is for adults who have already finished a previous study of this drug. The goal is to see how well the drug controls arthritis symptoms over time and to monitor any side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 350 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2025
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Rheumatoid arthritis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Peking Union Hospital, Chinese Academy of Medical Sciences
RECRUITINGBeijing, Beijing Municipality, 100022, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Scientists probe why rheumatic pain feels different for everyone
- A new ankle? researchers track 400 people with an implant meant to restore movement
- Can a Job-Focused rehab program keep arthritis patients employed?
- Do rheumatic diseases quietly damage the Eye's oil glands?
- Hidden kidney damage may lurk in rheumatoid arthritis patients
- Can a new injection calm rheumatoid arthritis? an early trial puts ZB002 to the test