A Phase 2 interventional study of TLL-018 and Placebo in Rheumatoid Arthritis (RA), sponsored by Hangzhou Highlightll Pharmaceutical Co., Ltd. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Hangzhou Highlightll Pharmaceutical Co., Ltd · Phase 2, Interventional, and Treatment
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Among 249 studies in Arthritis, Rheumatoid with a site in China — 63 open to participants now, 72 under way, 3 of them phase 3. Arthritis, Rheumatoid · China.
Among the 249 studies in Arthritis, Rheumatoid with a site in China, this one is the 130th largest by planned enrollment of the 217 interventional ones that give a count, is one of 19 that started in 2026, is one of 34 in phase 2, reaches primary completion later than 43 of the 71 other live ones, and was the 246th registered.
3,334 studies on the registry are indexed under Arthritis, Rheumatoid; 444 are open to participants now.
Browse Arthritis, Rheumatoid studies →63 of the 249 studies in Arthritis, Rheumatoid with a site in China are open now. Recruiting first, the newest first:
Bristol-Myers Squibb · Sites in China, United States, Belgium and 8 more countries
Ages 18–65
Peking University People's Hospital · Sites in China
Ages 18+
Jacobio Pharmaceuticals Co., Ltd. · Sites in China
Ages 18–75
Peking Union Medical College Hospital · Sites in China
Ages 18–65
The First Affiliated Hospital with Nanjing Medical University · Sites in China
Ages 18–70
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
249 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 58 · Phase 2 46 · Phase 3 52 · Phase 4 28
First in 2003; this study’s year is marked. 19 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 90 is close to the median of 95 across 2,221 interventional studies indexed under Arthritis, Rheumatoid.
Median enrollment 134 across the 217 interventional studies, 287 across the 32 observational. Of the 115 that completed or were terminated, 28 (24%) have results posted.
This tab as a report to print or save as PDF → With an account.
129 of 249 have an industry lead sponsor. The 10 most frequent:
Hangzhou Highlightll Pharmaceutical Co., Ltd is the lead sponsor of 14 studies on the registry; 5 are open to participants now.
Hangzhou Highlightll Pharmaceutical Co., Ltd has 4 studies filed under Arthritis, Rheumatoid — fewer than ten, so there is no comparison to draw.
16 of the studies in Arthritis, Rheumatoid with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06887127Phase 3Hangzhou Highlightll Pharmaceutical Co., LtdA Long-term Extension Clinical Study of TLL-018 in Patients With Rheumatoid Arthritis | 2026-12-31 |
| NCT07408024Toll Biotech Co. Ltd. (Beijing)Safety and Efficacy of TollB-001 Tablets in Moderate to Severe Rheumatoid Arthritis | 2026-12 |
| NCT07045896Peking University People's HospitalFucoidan in the Treatment of Active Rheumatoid Arthritis | 2026-12 |
| NCT06945666Jie ChangA Study of Iguratimod in Combination With Tofacitinib in RA Patients | 2027-01-31 |
| NCT07491016Zhejiang Provincial People's HospitalEfficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis | 2027-03-30 |
Add all 16 to your calendar (.ics) → With an account.
Among the 249 studies in Arthritis, Rheumatoid with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a randomized, double-blind, placebo-controlled parallel-group Phase II study. The study aims to evaluate the efficacy and safety of TLL-018 in adult patients with moderate to severe active rheumatoid arthritis who have inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).
The study will consist of a 35-day screening period, a 12-week randomized, double-blind, parallel-group, placebo-controlled treatment period (Period 1: primary efficacy observation period), a 12-week open-label treatment period with TLL-018 (Period 2: extension observation period), and a 14-day safety follow-up period.
Approximately 90 study participants will be randomized at a 2:1 ratio to the TLL-018 20 mg group (treatment group, 60 participants, administered twice daily [BID]) or the placebo group (placebo group, 30 participants, administered twice daily [BID]).
Treatment group: TLL-018 20 mg BID in Period 1 → TLL-018 20 mg BID in Period 2 Placebo group: Placebo BID in Period 1 → TLL-018 20 mg BID in Period 2
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1 Aged 18 to 70 years inclusive, any sex; [BMI = weight (kg)/height² (m²)] ≤ 35 kg/m².
2 "Meets the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for active rheumatoid arthritis (RA), with a disease duration of at least 3 months at the screening visit： Has received conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for ≥ 3 months prior to screening, with a stable dose for at least 4 weeks before randomization； Active rheumatoid arthritis meeting all of the following criteria: ≥6 swollen joints (SJC, 66-joint count) and ≥6 tender joints (TJC, 68-joint count) at screening and baseline visits. Joints that have undergone major surgery or received intra-articular injection within 4 weeks before randomization will be excluded from SJC and TJC counts. High-sensitivity C-reactive protein (hsCRP) > (ULN) or ≥5 mg/L at baseline (CRP testing is acceptable; hsCRP is preferred)." 3 Functional Class I, II, or III according to the 1991 American College of Rheumatology (ACR) rheumatoid arthritis functional classification criteria.
4 "Organ function must satisfy the following laboratory criteria: Bone marrow: ≥90 g/L; ≥100 ×10⁹/L; ≥1.5 ×10⁹/L; lymphocyte count ≥0.8 ×10⁹/L; white blood cell count ≥2.5 ×10⁹/L.
Hepatic function: total ≤1.5 × ULN; (AST) OR alanine aminotransferase (ALT) ≤1.5 × ULN.
Renal function: serum creatinine \<1.2 × ULN. Urinalysis: urine protein ≤1+. If urine protein >1+, a 24-hour urine protein collection is required, with total urinary protein ≤1 g." 5 Women of (WOCBP) must not be pregnant or breastfeeding. A pregnancy test (e.g., β-HCG assay) must be performed prior to study entry (last menstrual period will be documented). All participants and their partners must agree to use effective (as judged by the Investigator) from the first dose of product until at least 90 days after the last dose (see Appendix 12). Participants must have no plans to donate sperm or ova from screening through at least 6 months after the last study drug administration.
6 The participant understands the form, voluntarily agrees to participate in the study, and provides written informed consent. Informed consent must be obtained prior to performance of any study-related procedures.
Exclusion Criteria:
1 Evidence or diagnosis of other rheumatic diseases prior to screening (secondary Sjögren's syndrome excluded), including systemic lupus erythematosus, psoriatic arthritis, mixed connective tissue disease, primary Sjögren's syndrome, dermatomyositis, polymyositis, systemic sclerosis, and ankylosing spondylitis.
2 Presence of active fibromyalgia that, in the Investigator's judgment, may interfere with the evaluation of rheumatoid arthritis disease activity.
3 Prior diagnosis of other systemic inflammatory diseases, including but not limited to juvenile chronic arthritis, inflammatory bowel disease, active vasculitis (excluding venous rheumatoid nodules), spondyloarthropathy, and psoriatic arthritis.
4 Diagnosis of Felty's syndrome (rheumatoid arthritis with splenomegaly). 5 Presence of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric, or cerebral diseases that, in the Investigator's opinion, would place the participant at unacceptable risk.
6 A history of lymphoproliferative disorders (including but not limited to EBV-associated lymphoproliferative diseases, lymphoma, and leukemia), or presence of any current signs or symptoms suggestive of active lymphoproliferative disease.
7 A previous history of severe hematological diseases such as aplastic anemia and myelodysplastic syndrome, or any disease condition that may cause hemolysis or erythrocyte instability, including malaria and hemolytic anemia.
8 Current or previous history of thrombocytopenia, coagulation disorders, or function disorders.
9 History of cardiovascular or cerebrovascular events or surgeries within 12 months prior to screening, including but not limited to myocardial infarction, unstable angina, acute coronary syndrome, cerebral hemorrhage, cerebral infarction, coronary stent implantation, percutaneous transluminal coronary angioplasty, and coronary artery bypass grafting.
10 History of thromboembolic events within 12 months prior to screening (e.g., pulmonary thromboembolism, deep vein thrombosis, mesenteric arterial embolism), or presence of current high thromboembolic risk factors, such as immobilization within 12 weeks before screening, congenital or hereditary thrombophilia, or antiphospholipid antibody syndrome.
11 History of gastrointestinal perforation prior to screening (perforation caused by appendicitis or trauma is excluded).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TLL-018 20 mg, administered orally twice daily (BID) for 12 weeks during the double-blind treatment period. Eligible participants completing the double-blind phase may continue to receive TLL-018 in the subsequent 12-week open-label extension period.
Drug: TLL-018
Matching placebo for TLL-018, administered orally twice daily (BID) for 12 weeks during the double-blind treatment period. Eligible participants completing the double-blind phase may transition to receive TLL-018 in the subsequent 12-week open-label extension period.
Drug: Placebo
Treatment group: TLL-018 20 mg BID in Period 1 → TLL-018 20 mg BID in Period 2
Placebo group: Placebo BID in Period 1 → TLL-018 20 mg BID in Period 2
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Participants who met all of the following 3 conditions for improvement from baseline were classified as achieving the ACR20 response criteria: 1. ≥ 20% improvement in tender joint count (68 joints); 2. ≥ 20% improvement in swollen joint count (66 joints); and 3. ≥ 20% improvement in at least 3 of the following 5 parameters: 1. Physician's Global Assessment of Disease Activity (PGA); 2. Patient's Global Assessment of Disease Activity (PtGA); 3. Patient self-assessed pain (VAS); 4. Health Assessment Questionnaire Disability Index (HAQ-DI); 5. High-sensitivity C-reactive protein (hsCRP); C-reactive protein (CRP) is also acceptable.
Time frame: Week 12
Percentage of Participants With an American College of Rheumatology 20/50/70% (ACR20/50/70) Response
Participants who met all of the following 3 conditions for improvement from baseline were classified as achieving the ACR20/50/70 response criteria: 1. ≥ 20/50/70% improvement in tender joint count (68 joints); 2. ≥ 20/50/70% improvement in swollen joint count (66 joints); and 3. ≥ 20/50/70% improvement in at least 3 of the following 5 parameters: 1. Physician's Global Assessment of Disease Activity (PGA); 2. Patient's Global Assessment of Disease Activity (PtGA); 3. Patient self-assessed pain (VAS); 4. Health Assessment Questionnaire Disability Index (HAQ-DI); 5. High-sensitivity C-reactive protein (hsCRP); C-reactive protein (CRP) is also acceptable.
Time frame: Week 2 to Week 24 (ACR20, excluding Week 12)
Change From Baseline in Disease Activity Score 28 (DAS28) (hsCRP)
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Time frame: Baseline to Week 24
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(hsCRP)
Low disease activity based on DAS28 (hsCRP) is defined a DAS28 (hsCRP) score of ≤ 3.2.
Time frame: Week 2 to Week 24
Percentage of Participants Achieving Clinical Remission Based on DAS28 (hsCRP)
Clinical remission (CR) based on DAS28 (hsCRP) is defined as achieving a DAS28 (hsCRP) score of less than 2.6.
Time frame: Week 2 to Week 24
Change From Baseline in CDAI Scores
Change from baseline in Clinical Disease Activity Index (CDAI) at scheduled assessment time points. CDAI = tender joint count (68 joints) + swollen joint count (66 joints) + Physician's Global Assessment + Patient's Global Assessment.
Time frame: Baseline to Week 24
Change From Baseline in SDAI Scores
Change from baseline in Simplified Disease Activity Index (SDAI) at scheduled assessment time points. SDAI = CDAI + high-sensitivity C-reactive protein (hsCRP).
Time frame: Baseline to Week 24
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
he Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.
Time frame: Baseline to Week 24
Change From Baseline in Duration of Morning Stiffness
Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days. A negative change from Baseline indicates improvement.
Time frame: Baseline to Week 24
Change From Baseline in Patient's Assessment of Pain
Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale (VAS) from 0 to 10. A score of 0 indicates "no pain" and a score of 10 indicates "worst possible pain." A negative change from Baseline indicates improvement.
Time frame: Baseline to Week 24
Change From Baseline in Patient's Global Assessment of Disease Activity (PtGA)
Participants rated their disease activity for the past 24 hours using a Patient's Global Assessment of Disease Activity Global visual analogue scale (VAS). The range is 0 to 10 cm, with 0 representing no disease activity and 10 representing severe disease activity. Negative values indicate improvement from baseline.
Time frame: Baseline to Week 24
Change From Baseline in Physician's Global Assessment of Disease Activity (PGA)
The physician assessed a participant's disease activity at the time of the visit using a Physician's Global Assessment of Disease visual analogue scale (VAS). The range is 0 to 100 cm, with 0 representing no disease activity and 10 representing severe disease activity. Negative values indicate improvement from baseline.
Time frame: Baseline to Week 24
Change From Baseline in Morning Stiffness Severity
Morning stiffness severity was assessed by a numeric rating-scale (NRS). Participants rated the severity of morning stiffness during the past week from 0 to 10 with 0 representing "not severe" and 10 "very severe". Negative values indicate improvement from baseline.
Time frame: Baseline to Week 24
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria
The CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Low Disease Activity (LDA) based on CDAI is defined as achieving a total CDAI score of less than or equal to 10.
Time frame: Week 2 to Week 24
Plan to share: Undecided — The decision regarding IPD sharing is pending and will be made based on the study results and sponsor's data sharing policy.
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Jul 2027, 10 months after the start.
Of 116 industry-sponsored phase 2 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 24. This study's planned 10 months is below that.
Counting every sponsor, half of 158 studies reached it within 18 months; a quarter within 13 and three quarters within 30.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Sep 2026, on Sep 28, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drug tested here: TLL-018
Hangzhou Highlightll Pharmaceutical Co., Ltd →