The Safety and Efficacy of TLL-018 in Active Rheumatoid Arthritis

  • STATUS
    Recruiting
  • End date
    Jun 25, 2023
  • participants needed
    100
  • sponsor
    Hangzhou Highlightll Pharmaceutical Co., Ltd
Updated on 25 April 2022
methotrexate
tofacitinib
hydroxychloroquine
DMARD
sulfasalazine
rheumatism
leflunomide
chloroquine
rheumatoid factor
antirheumatics

Summary

This is a randomized, double-blind, double-dummy, tofacitinib-parallel-group, phase 2A study to assess the safety and efficacy of TLL-018 in active rheumatoid arthritis subject who had an inadequate response or intolerance to methotrexate.

Details
Condition Rheumatoid Arthritis
Treatment tofacitinib, TLL-018
Clinical Study IdentifierNCT05133297
SponsorHangzhou Highlightll Pharmaceutical Co., Ltd
Last Modified on25 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosed with RA based on either the 1987-revised American College of Rheumatology (ACR) classification criteria or the 2010 ACR/European League against Rheumatism (EULAR) criteria and have an inadequate response or intolerance to methotrexate
Subjects must have been receiving oral or parenteral methotrexate therapy ≥ 3 months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to Baseline Visit
Have active RA as defined by the following minimum disease activity criteria
≥ 6 swollen joints (based on 66 joint counts) at Screening and Baseline Visits
≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits
high-sensitivity C-reactive protein (hsCRP) > upper limit of normal (ULN) OR positive for both rheumatoid factor and anti-cyclic citrullinated peptide (CCP) at Screening
For subjects with inadequate response to methotrexate, subjects must have discontinued
all oral disease-modifying anti-rheumatic drugs (DMARDs) prior to Baseline
Visit as specified below or for at least five times the mean terminal
elimination half-life of a drug, whichever is longer
≥4 weeks prior to Baseline Visit for minocycline, penicillamine, sulfasalazine, hydroxychloroquine, chloroquine, azathioprine, gold formulations, cyclophosphamide
≥12 weeks prior to Baseline Visit for leflunomide if no elimination procedure was followed, or adhere to a washout procedure (i.e., 11 days washout with colestyramine, or 30 days washout with activated charcoal)
The organ function level must meet the following requirements
Bone marrow: Blood routine results showed hemoglobin ≥90g/L, platelet ≥100×109/L
neutrophil absolute count ≥1.5×109/L; Liver: serum bilirubin ≤1.5 times the upper limit of
normal value, aspartate aminotransferase (AST) ≤1.5 times the upper limit of normal value
alanine aminotransferase (ALT) ≤1.5 times the upper limit of normal value; Serum creatinine
<1.5 times the upper limit of normal value; Urine protein ≤1+, if urine protein >1+, urine
protein should be collected for 24 hours, the total amount should be ≤1 g. Female subjects
of childbearing potential must test negative for pregnancy

Exclusion Criteria

History of Felty syndrome (Rheumatoid arthritis - Splenomegaly syndrome)
A history of herpes zoster or disseminated herpes simplex
Treatment with any JAK inhibitor (tofacitinib, baricitinib, ruxolitinib) within 2
weeks prior to study start
Subjects have severe, progressive or uncontrollable symptoms of kidney, liver, blood
gastrointestinal, lung, cardiovascular, neurological or brain disease
Current treatment or treatment within 4 weeks or 5 half-lives (whichever is longer)
prior to the first dose of study medication with another investigational medication or
current enrollment in another investigational drug protocol
If the laboratory T-Spot test (or other TB diagnostic test) is positive, the
investigator will determine the activity based on the history and clinical
manifestations, and the patients diagnosed as active TB should be excluded
Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface
antigen (HBsAg), or hepatitis C antibody
Pregnant or breastfeeding female
Clear my responses

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