WITHDRAWN

A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2)

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Telitacicept Compared to Placebo in Patients With Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2)

Quick Facts

Study Start:2024-09

Study Completion:2025-01-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:WITHDRAWN

Study ID

NCT06456567

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 12-70 years at screening. 2. Has a diagnosis of SLE for at least 6 months prior to the screening visit. 3. Meets the 2019 EULAR/ACR Classification criteria for SLE. 4. Moderately to severely active SLE definined by the following: 1. SELENA SLEDAI total score ≥6 points with clinical SLEDAI score ≥4 points at screening; 2. BILAG organ system scores of at least 1A or 2B at screening. 5. Clinical SLEDAI score of ≥4 at Day 0 prior to randomization. 6. At least one positive serologic parameter within the screening period. 7. Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.	1. Active lupus nephritis undergoing induction therapy or unstable renal diseases within 12 weeks prior to screening. 2. Active or unstable neuropsychiatric SLE. 3. Autoimmune or rheumatic disease other than SLE. 4. History of arterial or venous thromboembolism or microangiopathy within 12 months prior to screening. 5. History of non-SLE disease requiring treatment with oral or parenteral. glucocorticosteroids for more than a total of 2 weeks within the last 24 weeks prior to screening.

Inclusion Criteria

Exclusion Criteria

1. Age 12-70 years at screening.
2. Has a diagnosis of SLE for at least 6 months prior to the screening visit.
3. Meets the 2019 EULAR/ACR Classification criteria for SLE.
4. Moderately to severely active SLE definined by the following:
1. SELENA SLEDAI total score ≥6 points with clinical SLEDAI score ≥4 points at screening;
2. BILAG organ system scores of at least 1A or 2B at screening.
5. Clinical SLEDAI score of ≥4 at Day 0 prior to randomization.
6. At least one positive serologic parameter within the screening period.
7. Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.

1. Active lupus nephritis undergoing induction therapy or unstable renal diseases within 12 weeks prior to screening.
2. Active or unstable neuropsychiatric SLE.
3. Autoimmune or rheumatic disease other than SLE.
4. History of arterial or venous thromboembolism or microangiopathy within 12 months prior to screening.
5. History of non-SLE disease requiring treatment with oral or parenteral. glucocorticosteroids for more than a total of 2 weeks within the last 24 weeks prior to screening.

Contacts and Locations

Study Locations (Sites)

Hemet site

Hemet, California, 92543

United States

Menifee site

Menifee, California, 92586

United States

Rockford site

Rockford, Illinois, 61114

United States

Stafford site

Stafford, Texas, 77477

United States

Collaborators and Investigators

Sponsor: Vor Biopharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09

Study Completion Date2025-01-06

Study Record Updates

Study Start Date2024-09

Study Completion Date2025-01-06

Terms related to this study

Keywords Provided by Researchers

Systemic Lupus Erythematosus
SLE

Additional Relevant MeSH Terms

Systemic Lupus Erythematosus