NCT06394063

Brief Summary

This study is a randomized, double-blind, placebo-controlled single-center clinical trial. The aim of this study is to investigate the efficacy and safety of low-dose telitacicept for prevention of flares in SLE patients with low disease activity.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Jun 2024Jun 2027

First Submitted

Initial submission to the registry

April 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 28, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

3 years

First QC Date

April 28, 2024

Last Update Submit

July 2, 2024

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with disease flares

    Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).

    52 weeks

Secondary Outcomes (8)

  • Percentage of patients with mild/moderate flares

    52 weeks

  • Percentage of patients with major flares

    52 weeks

  • Time to first disease flare

    52 weeks

  • Prednisone dose at each visit

    52 weeks

  • PGA score at each visit

    52 weeks

  • +3 more secondary outcomes

Other Outcomes (1)

  • Subgroup analysis

    52 weeks

Study Arms (2)

Telitacicept

EXPERIMENTAL

Telitacicept 160mg is administered subcutaneously every other week for 26 times on the background of standard therapy.

Biological: Telitacicept

Placebo

PLACEBO COMPARATOR

Placebo is administered subcutaneously every other week for 26 times on the background of standard therapy.

Drug: Placebo

Interventions

TelitaciceptBIOLOGICAL

Telitacicept 160 mg SC every other week

Telitacicept
PlaceboDRUG

Placebo to Telitacicept

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years;
  • SLE patients with low disease activity (SELENA-SLEDAI score\< 8 at screening ); disease duration more than 3 months；no British Isles Lupus Assessment Group (BILAG) A and no more than one B;
  • A stable treatment regimen with fixed doses of prednisone (≤ 30mg/day), antimalarial, or immunosuppressive drugs (mycophenolate mofetil/azathioprine/ciclosporin /tacrolimus/methotrexate/leflunomide) for at least 3 months;
  • Sign the informed consent.

You may not qualify if:

  • Hepatic or renal dysfunction: alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \> 2 times upper normal limits; GFR \< 60ml/min;
  • Exposure to cyclophosphamide within past 6 months before screening;
  • Exposure to any B cell targeted therapy (Rituximab/Belimumab/Telitacicept) within past 6 months before screening;
  • Pregnant women, lactating women;
  • History of Malignancy within the last 5 years, excluding adequately treated skin tumors (basal cell or squamous cell carcinoma) or carcinoma in situ of cervix;
  • Active hepatitis or a history of severe liver disease;
  • Current infections (HIV/tuberculosis/COVID-19, etc.) at screening;
  • A significant decrease in immunoglobulin level, IgG\<5g/L;
  • Not suitable for the study in the opinion of the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ren Ji Hospital

Shanghai, 201112, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

telitacicept

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Ting Li

CONTACT

+8613916927066leeting007@163.com

Shuang Ye

CONTACT

ye_shuang2000@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2024

First Posted

May 1, 2024

Study Start

June 28, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations

CN(1)