Rheumatoid Arthritis (RA)Phase 2NCT07748728
TLL-018 in Patients With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response or Intolerance to csDMARDs
A Phase 2 study testing TLL-018 in people with Rheumatoid Arthritis (RA), run by Hangzhou Highlightll Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- TLL-018
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 Aged 18 to 70 years inclusive, any sex; body mass index [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) > upper limit of normal (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: hemoglobin ≥90 g/L; platelets ≥100 ×10⁹/L; absolute neutrophil count ≥1.5 ×10⁹/L; lymphocyte count ≥0.8 ×10⁹/L; white blood cell count ≥2.5 ×10⁹/L.
- Hepatic function: total bilirubin ≤1.5 × ULN; aspartate aminotransferase (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 childbearing potential (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 contraception (as judged by the Investigator) from the first dose of investigational 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 informed consent 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.
Who cannot join
- 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.
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- 8 Current or previous history of thrombocytopenia, coagulation disorders, or platelet 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of TLL-018 in Patients With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response or Intolerance to csDMARDs
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).
Read the detailed description
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
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- TLL-018, Placebo
- Keywords
- TLL-018 tablet, Arthritis, Rheumatoid, Janus Kinase Inhibitors, Antirheumatic Agents, Drug Resistance, Treatment Failure
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLL-018Drug
Treatment group: TLL-018 20 mg BID in Period 1 → TLL-018 20 mg BID in Period 2
PlaceboDrug
Placebo group: Placebo BID in Period 1 → TLL-018 20 mg BID in Period 2
| Study group | Role | What they receive |
|---|---|---|
| TLL-018 20mg | Experimental | 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. Receives: Drug: TLL-018 |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- ≥ 20% improvement in tender joint count (68 joints);
- ≥ 20% improvement in swollen joint count (66 joints); and
- ≥ 20% improvement in at least 3 of the following 5 parameters:
- Physician's Global Assessment of Disease Activity (PGA);
- Patient's Global Assessment of Disease Activity (PtGA);
- Patient self-assessed pain (VAS);
- Health Assessment Questionnaire Disability Index (HAQ-DI);
- High-sensitivity C-reactive protein (hsCRP); C-reactive protein (CRP) is also acceptable.
Measured: Week 12
Secondary outcomes (13)
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:
- ≥ 20/50/70% improvement in tender joint count (68 joints);
- ≥ 20/50/70% improvement in swollen joint count (66 joints); and
- ≥ 20/50/70% improvement in at least 3 of the following 5 parameters:
- Physician's Global Assessment of Disease Activity (PGA);
- Patient's Global Assessment of Disease Activity (PtGA);
- Patient self-assessed pain (VAS);
- Health Assessment Questionnaire Disability Index (HAQ-DI);
- High-sensitivity C-reactive protein (hsCRP); C-reactive protein (CRP) is also acceptable.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 2 to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start18 Sep 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Highlightll Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zeng Xiaofeng Zeng, PhD, Principal investigator, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748728
- Sponsor's protocol ID
- TLL-018-208
- Status last verified
- Sep 2026
- First submitted
- 31 Jul 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding IPD sharing is pending and will be made based on the study results and sponsor's data sharing policy.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of TLL-018 in Patients With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response or Intolerance to csDMARDs
- ClinicalTrials.gov ID
- NCT07748728
- Acronym / sponsor ID
- TLL-018-208
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- TLL-018 tablet, Arthritis, Rheumatoid, Janus Kinase Inhibitors, Antirheumatic Agents, Drug Resistance, Treatment Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hangzhou Highlightll Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TLL-018 20mg | Experimental | Drug: TLL-018TLL-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. |
| Placebo | Placebo comparator | Drug: PlaceboMatching 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1 Aged 18 to 70 years inclusive, any sex; body mass index [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) > upper limit of normal (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: hemoglobin ≥90 g/L; platelets ≥100 ×10⁹/L; absolute neutrophil count ≥1.5 ×10⁹/L; lymphocyte count ≥0.8 ×10⁹/L; white blood cell count ≥2.5 ×10⁹/L.
- Hepatic function: total bilirubin ≤1.5 × ULN; aspartate aminotransferase (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 childbearing potential (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 contraception (as judged by the Investigator) from the first dose of investigational 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLL-018Treatment group: TLL-018 20 mg BID in Period 1 → TLL-018 20 mg BID in Period 2 | Drug | TLL-018 20mg |
| PlaceboPlacebo group: Placebo BID in Period 1 → TLL-018 20 mg BID in Period 2 | Drug | Placebo |
Primary outcome
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Time frame: 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.
13 secondary outcomes
Percentage of Participants With an American College of Rheumatology 20/50/70% (ACR20/50/70) Response
Time frame: Week 2 to Week 24 (ACR20, excluding Week 12)
Change From Baseline in Disease Activity Score 28 (DAS28) (hsCRP)
Time frame: Baseline to Week 24
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(hsCRP)
Time frame: Week 2 to Week 24
Percentage of Participants Achieving Clinical Remission Based on DAS28 (hsCRP)
Time frame: Week 2 to Week 24
Change From Baseline in CDAI Scores
Time frame: Baseline to Week 24
Change From Baseline in SDAI Scores
Time frame: Baseline to Week 24
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: Baseline to Week 24
Change From Baseline in Duration of Morning Stiffness
Time frame: Baseline to Week 24
Change From Baseline in Patient's Assessment of Pain
Time frame: Baseline to Week 24
Change From Baseline in Patient's Global Assessment of Disease Activity (PtGA)
Time frame: Baseline to Week 24
Change From Baseline in Physician's Global Assessment of Disease Activity (PGA)
Time frame: Baseline to Week 24
Change From Baseline in Morning Stiffness Severity
Time frame: Baseline to Week 24
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria
Time frame: Week 2 to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Undecided. The decision regarding IPD sharing is pending and will be made based on the study results and sponsor's data sharing policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zeng Xiaofeng Zeng, PhD principal investigator
Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TLL-018 in people with Rheumatoid Arthritis (RA), run by Hangzhou Highlightll Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.