A Study to Evaluate the Safety, Tolerability, and PK Profile of Single and Multiple Doses TJ202 in Patient With Systemic Lupus Erythematosus

NCT05140824 | Terminated Phase 1

• 1 other identifier: TJ202001SLE101
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

A Multicenter, Randomized, Double-blind, Placebo-Controlled, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Doses of TJ202 in Patients with Systemic Lupus Erythematosus

Conditions

Systemic Lupus Erythematosus (SLE)

Keywords

Evaluate the Safety, Tolerability; A Multicenter, Randomized, Double-blind, Placebo-Controlled, Phase 1 Clinical Study

Outcome Measures

Primary Outcomes (8)

• Rate of Adverse Events

  Evaluate the rate of adverse events

  43 days post last dose for single dose

• Rate of Adverse Events

  Evaluate the rate of adverse events

  113 days post last dose for multi- dose

• Pharmacokinetic(PK) Parameters: Cmax

  Cmax

  43 days post last dose for single dose,

• Pharmacokinetic(PK) Parameters: Cmax

  Cmax

  113 days post last dose for multi- dose

• Pharmacokinetic(PK) Parameters: Tmax

  Tmax

  43 days post last dose for single dose,

• Pharmacokinetic(PK) Parameters: Tmax

  Tmax

  113 days post last dose for multi- dose

• Pharmacokinetic(PK) Parameters: AUC

  AUC0-tlast

  43 days post last dose for single dose,

• Pharmacokinetic(PK) Parameters: AUC

  AUC0-tlast

  113 days post last dose for multi- dose

Study Arms (2)

Placebo

PLACEBO COMPARATOR

0.9% sodium chloride solution

Drug: Placebo

TJ202

EXPERIMENTAL

TJ202 injection

Biological: TJ202 injection

Interventions

Placebo DRUG

0.9% sodium chloride solution

Placebo

TJ202 injection BIOLOGICAL

TJ202 injection

TJ202

Eligibility Criteria

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

You may qualify if:

• Single Dose:
• Male or female, 18-65 years old (inclusive), weight of ≥ 45 kg.
• Definite diagnosis of systemic lupus erythematosus (see Annex 3. SLE Classification Criteria by SLICC 2012 for diagnostic criteria), and an SLE disease activity index (SLEDAI) score of \< 15 (see Annex 4. SLE Disease Activity Score \[SLEDAI-2000\] for scoring criteria) . A positive antinucleus antibody (ANA) test result.
• If a subject is receiving SLE treatment, a stable SLE regimen must be maintained up to the date of the first dose of study drug (the permitted medications and their maximum doses are as follows):
• Glucocorticoids: prednisone 10 mg/day or other glucocorticoids with an equivalent dose. It should be stable for at least 4 weeks prior to receiving the first dose of study drug.
• Other immunosuppressive drugs alone or in combination with glucocorticoids include the following: azathioprine (maximum dose of 100 mg/day), methotrexate (maximum dose of 15 mg/week), mycophenolate mofetil (maximum dose of 1500 mg/day), tripterygium wilfordii polyglycosides (maximum dose of 60 mg/day), leflunomide (maximum dose of 20 mg/day), tacrolimus (maximum dose of 4 mg/day), ciclosporin (maximum dose of 100 mg/day). The above medications should be used for at least 12 weeks and stable for at least 4 weeks prior to receiving the first dose of study drug.
• Hydroxychloroquine: The maximum allowable dose is 400 mg/day, and combination with the immunosuppressants listed above is allowed. It should be used for at least 12 weeks and the dose should be stable for at least 4 weeks prior to receiving the first dose of study drug.
• The subject is willing to participate in the study and voluntarily sign the ICF.
• Subjects of childbearing potential or subjects with a partner of childbearing potential must agree to use effective contraceptive measures throughout the study (except oral estrogens, estrogenic vaginal ring, etc., refer to Annex 5. Contraceptive Measures, Definitions of Women of Childbearing Potential and Contraception Requirements for optional contraceptive methods).
• dsDNA antibody titer (ELISA) greater than or equal to 1.5 times the upper limit of normal (ULN).

You may not qualify if:

• Central nervous system (CNS) diseases: active central nervous system lupus (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, or CNS vasculitis), visual disturbance, cranial neuropathy within 60 days prior to screening, with intervention required.
• Renal disorders: nephrotic syndrome (protein urine \> 3.5 g/24 h) within 30 days prior to screening, or requiring protocol-prohibited medications (such as intravenous cyclophosphamide) for active nephritis, or requiring hemodialysis or high-dose glucocorticoids such as prednisone of ≥ 100 mg/day (or other glucocorticoids with equivalent doses).
• Cardiovascular disorders: history of acute myocardial infarction, or unstable angina, severe arrhythmia (multifocal frequent ventricular premature beats, ventricular tachycardia, ventricular fibrillation), etc. over the past six months; New York Heart Association (NYHA) Class III-IV (see Annex 6. NYHA for details).
• Subjects with a known history of moderate or severe persistent asthma (assessed by the Asthma Severity Scale of the National Heart, Lung, and Blood Institute \[NHLB\]) within the past 5 years, or who currently have uncontrolled asthma (of any grade).
• Asthma and specific dermatitis, etc. requiring glucocorticoid-dependent therapy (except topical glucocorticoids).
• Infections, requiring treatment for acute or chronic infections, as follows:
• Treatment with any inhibitory therapy currently for chronic infections (e.g., tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, zoster virus and atypical mycobacteriosis);
• Hospitalization for an infection within 60 days prior to dosing;
• Treatment with anti-infective drugs (antibacterials, antivirals, antifungals, or antiparasites) by parenteral administration (IV or IM) 60 days prior to dosing.
• Subjects with mycobacterium tuberculosis, including those with a positive "T-cell spot test for tuberculosis infection (T-SPOT)" (latent tuberculosis infection: except those who have completed tuberculosis prophylaxis for 4 weeks before their first dose), or those with a positive imaging result.
• Subjects with positive results from any of the following tests: hepatitis B surface antigen (HBs Ag), hepatitis B core antibody (HBc Ab), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), or treponema pallidum antibody (TPPA). Patients who tested positive for hepatitis B core antibody (HBc Ab) but negative for HBV-DNA should be excluded.
• Hematological system diseases or hematology abnormalities: subjects with previous or current hematological system diseases (including but not limited to: myelofibrosis, anemia aplastic aregenerative, leukemia, lymphoma, etc.), hematology with hemoglobin \< 100 g/L, white blood cells \< 3.0 × 109/L, granulocytes \< 2.5 × 109/L, lymphocytes \< 0.8 × 109/L, or platelets \< 100 × 109/L.
• Abnormal liver function: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or glutamyl transpeptidase (GGT) values \> 2 times ULN; or total bilirubin or alkaline phosphatase (ALP) values \> 1.5 times ULN.
• Abnormal renal function: creatinine (Cr) or urea nitrogen (BUN) values \> 1.5 times the upper limit of normal (ULN); pre-screening estimated glomerular filtration rate (eGFR) ≤ 60 mL/min. Calculate eGFR values using the MDRD formula: eGFR (mL/min × 1.73 m2) = 175 × blood creatinine (\[Scr (mg/dL)\])-1.154 × age-0.203 × sex (M = 1, F = 0.742).
• Cancer: history of malignancy within the last 5 years.

Sponsors & Collaborators

• TJ Biopharma Co., Ltd.: lead

Study Sites (2)

The Second Affiliated Hosptial Zhejiang University School of Medicine

Zhejiang, Hangzhou, China

Location

Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: November 4, 2021
• First Posted: December 1, 2021
• Study Start: December 30, 2021
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

CN (2)