A Phase 3 Study Comparing TLL-018 to Tofacitinib in RA Subjects With Inadequate Response or Intolerance to bDMARDs

NCT06020144 | Active Not Recruiting Phase 3

• 1 other identifier: TLL-018-301
• Study Type: interventional
• Target: 459
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, double-dummy, positive-controlled, phase 3 study to assess the safety and efficacy of TLL-018 in active rheumatoid arthritis subjects who had an inadequate response or intolerance to Biologic DMARDs.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving American College of Rheumatology 50% (ACR50) Response

  ACR50 response: greater than or equal to (\>=) 50 percent (%) improvement in painful and tender joint count; \>= 50% improvement in swollen joint count; and \>= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP)at each visit.

  Week 24

Secondary Outcomes (7)

• Proportion of subjects achieving DAS28-hsCRP <2.6

  Week 24

• Proportion of subjects achieving American College of Rheumatology 20% (ACR20) and 70% (ACR70) Response

  Week 24

• Change From Baseline in Disease Activity Score Based on 28-Joints Count-High-Sensitivity C-reactive Protein (DAS28-hsCRP)

  Week 24

• Changes From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score

  Week 24

• Changes From Baseline in SF-36 Score

  Week 24

Study Arms (2)

sequence A

EXPERIMENTAL

TLL018 tablets, 2piece,BID

Drug: TLL-018

sequence B

ACTIVE COMPARATOR

Tofacitinib tablets, 1piece,BID

Drug: Tofacitinib

Interventions

TLL-018 DRUG

Oral tablets administered 2pieces BID for 52 weeks.

Also known as: TLL-018 tablets

sequence A

Tofacitinib DRUG

Oral tablets administered 1pieces BID for 52 weeks.

Also known as: Tofacitinib tablets

sequence B

Eligibility Criteria

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

You may qualify if:

• Aged between 18 and 65;
• Meet the diagnostic criteria of rheumatoid arthritis of the American College of Rheumatology/European Alliance against Rheumatism (ACR/EULAR,2010) with duration of at least 3 months;
• Meet the criteria for active rheumatoid arthritis；
• Have received at least one kind of bDMARDs for three months or longer and show inadequate response or intolerance to at least one kind of bDMARDs；
• Meet the ACR (1991) grading criteria of grade I, II or III；
• Discontinuation of bDMARDs or JAK inhibitors for more than four weeks；
• To sustain a stable status, oral administration of stable doses of glucocorticoids (≤ prednisone 10 mg/day or equivalent corticosteroids) and stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs) are allowed to use, provided that stable doses are maintained for at least one week prior to the study；
• BMI index is less than 35 kg/m2;
• Women of Child Bearing Potential (WOCBP) should not be pregnant or breastfeeding and the pregnancy test should be negative before randomization;
• Subjects (whether male or female) should have adequate barrier contraception during the whole treatment period and at least 90 days after treatment; subjects should avoid the sperm or ovum donation for at least six months after treatment；
• Subjects understand the informed consent form (ICF), volunteer for the study and sign the ICF;

You may not qualify if:

• With other rheumatic diseases;
• With other systemic inflammatory diseases;
• With progressive or uncontrolled symptoms of renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiovascular, neurologic, psychiatric, or cerebral disease;
• Previous history of severe hematologic diseases;
• Previous history of malignancy within five years, with exception of cured basal cell carcinoma or cutaneous squamous cell carcinoma or cervical carcinoma in situ.
• With active infection before randomization;
• Herpes zoster occurred within 1 year prior to randomization; disseminated or recurrent herpes zoster prior to randomization; disseminated herpes simplex before randomization;
• Previous history of active tuberculosis (TB) and no evidence of clinical cure or imaging evidence of active TB; or T-spot or PPD positive at screening but have received TB preventive therapy less than one month;
• HBsAg positive (or HBsAg negative but anti-HBc positive and HBV-DNA quantitative test positive), HCV antibody and HCV-RNA positive, or HIV antibody positive;
• Previous history of thrombocytopenia, coagulopathy, or platelet dysfunction;
• Previous history of cardiovascular and cerebrovascular accidents;
• Previous history of thromboembolism or risk factors;
• Previous history of gastrointestinal perforation;
• Temporary usage of NSAIDs within 48 hours prior to the baseline visit;
• Have received anti-rheumatic herb within 4 weeks before randomization;

Sponsors & Collaborators

• Hangzhou Highlightll Pharmaceutical Co., Ltd: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tofacitinib

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 31, 2023
• Study Start: November 15, 2023
• Primary Completion: January 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)