Systemic Lupus ErythematosusPhase 3NCT06456567
A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2)
A Phase 3 study testing Telitacicept in people with Systemic Lupus Erythematosus, run by Vor Biopharma at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Telitacicept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2024to 6 Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 12-70 years at screening.
- Has a diagnosis of SLE for at least 6 months prior to the screening visit.
- Meets the 2019 EULAR/ACR Classification criteria for SLE.
- Moderately to severely active SLE definined by the following:
- SELENA SLEDAI total score ≥6 points with clinical SLEDAI score ≥4 points at screening;
- BILAG organ system scores of at least 1A or 2B at screening.
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- Clinical SLEDAI score of ≥4 at Day 0 prior to randomization.
- At least one positive serologic parameter within the screening period.
- Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.
Who cannot join
- Active lupus nephritis undergoing induction therapy or unstable renal diseases within 12 weeks prior to screening.
- Active or unstable neuropsychiatric SLE.
- Autoimmune or rheumatic disease other than SLE.
- History of arterial or venous thromboembolism or microangiopathy within 12 months prior to screening.
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hemet site
Hemet, California, 92543
Menifee site
Menifee, California, 92586
Rockford site
Rockford, Illinois, 61114
Stafford site
Stafford, Texas, 77477
About this study
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)
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.
Read the detailed description
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease with heterogeneous manifestations and disease course. Despite advances in medical care, there are still significant unmet needs in SLE with diminished health-related quality of life (HRQoL), persistent disease activity, disease flares, intolerance to standard of care (SOC) therapies, and development of organ damage and co-morbidities.
Telitacicept is a fully human TACI-Fc fusion protein that targets B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). Blocking the interaction of BLyS and APRIL with their cell membrane receptors (TACI, B-cell maturation antigen (BCMA), and B-cell activating factor receptor (BAFF-R) would inhibit B cell proliferation and maturation, suppresses immune responses and may alleviate autoimmune symptoms.
This is a multicenter, randomized, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of telitacicept added to standard of care (SoC) therapy compared to placebo with SoC therapy in subjects with moderately to severely active SLE.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Telitacicept, Placebo
- Keywords
- Systemic Lupus Erythematosus, SLE
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelitaciceptBiological
Subcutaneous injection
PlaceboDrug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Telitacicept | Experimental | Telitacicept + Standard of Care (SOC) Receives: Biological: Telitacicept |
| Placebo | Placebo comparator | Placebo + Standard of Care (SOC) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SLE Responder Index (SRI-4)
Proportion of subjects achieving an SLE Responder Index (SRI-4) response
Measured: Week 52
Secondary outcomes (6)
SLE Responder Index (SRI-4)
Proportion of subjects achieving an SLE Responder Index (SRI-4) response
Measured: Week 24
Achieve and sustain a low dose of corticosteriods
Proportion of subjects achieving the target of corticosteroids reduction.
Measured: Week 52
SLE Responder Index (SRI-4) and sustaining a low dose of corticosteriods
Proportion of patients achieving an SRI-4 response at Week 52, while achieving and maintaining corticosteroids reduction.
Measured: Week 52
BILAG-based Combined Lupus Assessment (BICLA) Response
Proportion of patients achieving a BILAG-based Combined Lupus Assessment (BICLA) response at Week 52
Measured: Week 52
Time to Flare
Time to flare assessed by SELENA-SLEDAI Flare Index (SFI) from baseline through Week 52
Measured: Up to Week 52
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Proportion of patients achieving clinically meaningful improvement in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study startSep 2024 (estimated)
- Primary completion2 Jan 2025
- Study completion6 Jan 2025
Why it stopped: Sponsor business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vor Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456567
- Sponsor's protocol ID
- RC18G002
- Status last verified
- Jan 2026
- First submitted
- 7 Jun 2024
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06456567
- Acronym / sponsor ID
- RC18G002
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, SLE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vor BiopharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2024 (estimated)
- Primary completion
- 2 Jan 2025 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.
Detailed description
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease with heterogeneous manifestations and disease course. Despite advances in medical care, there are still significant unmet needs in SLE with diminished health-related quality of life (HRQoL), persistent disease activity, disease flares, intolerance to standard of care (SOC) therapies, and development of organ damage and co-morbidities.
Telitacicept is a fully human TACI-Fc fusion protein that targets B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). Blocking the interaction of BLyS and APRIL with their cell membrane receptors (TACI, B-cell maturation antigen (BCMA), and B-cell activating factor receptor (BAFF-R) would inhibit B cell proliferation and maturation, suppresses immune responses and may alleviate autoimmune symptoms.
This is a multicenter, randomized, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of telitacicept added to standard of care (SoC) therapy compared to placebo with SoC therapy in subjects with moderately to severely active SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telitacicept | Experimental | Biological: TelitaciceptTelitacicept + Standard of Care (SOC) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo + Standard of Care (SOC) |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age 12-70 years at screening.
- Has a diagnosis of SLE for at least 6 months prior to the screening visit.
- Meets the 2019 EULAR/ACR Classification criteria for SLE.
- Moderately to severely active SLE definined by the following:
- Clinical SLEDAI score of ≥4 at Day 0 prior to randomization.
Key exclusion criteria (5 listed)
- Active lupus nephritis undergoing induction therapy or unstable renal diseases within 12 weeks prior to screening.
- Active or unstable neuropsychiatric SLE.
- Autoimmune or rheumatic disease other than SLE.
- History of arterial or venous thromboembolism or microangiopathy within 12 months prior to screening.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelitaciceptSubcutaneous injection | Biological | Telitacicept |
| PlaceboSubcutaneous injection | Drug | Placebo |
Primary outcome
SLE Responder Index (SRI-4)
Time frame: Week 52
Proportion of subjects achieving an SLE Responder Index (SRI-4) response
6 secondary outcomes
SLE Responder Index (SRI-4)
Time frame: Week 24
Achieve and sustain a low dose of corticosteriods
Time frame: Week 52
SLE Responder Index (SRI-4) and sustaining a low dose of corticosteriods
Time frame: Week 52
BILAG-based Combined Lupus Assessment (BICLA) Response
Time frame: Week 52
Time to Flare
Time frame: Up to Week 52
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Time frame: Week 52
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telitacicept in people with Systemic Lupus Erythematosus, run by Vor Biopharma at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLE Responder Index (SRI-4) (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.