Systemic Lupus ErythematosusPhase 3NCT05306574
A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)
A Phase 3 study testing Telitacicept in people with Systemic Lupus Erythematosus, run by Vor Biopharma at 78 sites in 15 countries.
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
- 91 participants
- Where
- 78 sitesin 15 countries
- Study dates
- 20 Jun 2022to 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 defined 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.
Show all 9Show fewer
- 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
Trial locations and contacts
78 sites in 15 countries.
78 sites in 15 countries
Poland16 sites
Bydgoszcz Site
Bydgoszcz, 85-065
Bydgoszcz Site 2
Bydgoszcz, 85-168
Bydgoszcz Site 3
Bydgoszcz, 85-605
Bytom Site
Bytom, 41-902
Katowice Site
Katowice, 40-748
Krakow Site 1
Krakow, 31-501
Lodz Site
Lodz, 90-368
Malbork Site
Malbork, 82-200
Poznan Site 2
Poznan, 60-681
Poznan SIte
Poznan, 61-113
Poznań Site
Poznan, 61-731
Szczecin Site
Szczecin, 71-252
Warszawa Site 2
Warsaw, 00-874
Warszawa Site 3
Warsaw, 02-637
Warszawa Site
Warsaw, 04-305
Wroclaw Site 2
Wroclaw, 50-556
United States12 sites
Anniston, Alabama Site
Anniston, Alabama, 36207
Baytown Site
Baytown, Texas, 77521
Colleyville, Texas Site
Colleyville, Texas, 76034
Grand Blanc Site
Grand Blanc, Michigan, 48439
Houston Site
Houston, Texas, 77084
Miami, FL Site
Miami, Florida, 33014
Mission Hills Site
Mission Hills, California, 91345
Orange Site
Orange, California, 92868
Tampa, Florida Site
Tampa, Florida, 33765
Thousands Oaks Site
Thousand Oaks, California, 91360
Waco Site
Waco, Texas, 76710
Wheaton, Maryland Site
Wheaton, Maryland, 20902
Bulgaria9 sites
Pleven Site
Pleven, 5800
Plovdiv Site
Plovdiv, 4023
Ruse Site
Rousse, 7002
Sevlievo Site
Sevlievo, 5400
Sofia Site 1
Sofia, 1431
Sofia Site 4
Sofia, 1463
Sofia Site 5
Sofia, 1463
Sofia Site 3
Sofia, 1612
Stara Zagora Site
Stara Zagora, 6000
Argentina7 sites
Ciudad Autonoma Buenos Aires Site 2
Ciudad Autonoma Buenos Aires, C1046AAQ
Cordoba Site
Córdoba, X5000AVE
Quilmes Site
Quilmes, Buenos Aires, B1878DVB
Rosario Site
Rosario, Santa Fe Province, S2000PBJ
San Juan Site
San Juan, 5400
San Miguel de Tucuman Site 1
San Miguel de Tucumán, Tucumán Province, T4000AXL
San Miguel de Tucuman Site 2
San Miguel de Tucumán, Tucumán Province, T4000ICL
Colombia6 sites
Barranquilla site
Barranquilla, 080002
Barranquilla site
Barranquilla, 080020
Bucaramanga site
Bucaramanga, 680003
Medellin Site 1
Medellín, 050025
Medellin site 2
Medellín, 50021
Monteria site
Montería, 230002
Mexico5 sites
Cuernavaca Site
Cuernavaca, 62448
Guadalajara Site
Guadalajara, 44670
Mexico site 1
México, 06760
Mexico Site 2
México, 67000
Ciudad de Mexico Site
Mexico City, 06700
Philippines5 sites
Batangas Site
Batangas, 4217
Cagayan de Oro City Site
Cagayan de Oro, 9000
Los Baños Site
Los Baños, 4030
Makati City Site
Makati City, 1229
Manila Site
Manila, 1012
Chile4 sites
Santiago Site 4
Santiago, 7500010
Santiago Site 1
Santiago, 7500710
Santiago Site 3
Santiago, 7501126
Santiago Site 2
Santiago, 8330336
Hungary3 sites
Budapest Site
Budapest, 1097
Debrecen Site
Debrecen, 4032
Gyula Site
Gyula, 5700
Spain3 sites
Sevilla Site 1
Seville, 41010
Sevilla Site 2
Seville, 41013
Valencia Site
Valencia, 46017
Australia2 sites
Garran Site
Garran, Austl. Cap. Terr., 2605
Murdoch Site
Murdoch, Western Australia, 6150
Germany2 sites
Koeln Site
Cologne, North Rhine-Westphalia, 50937
Muenster Site
Münster, North Rhine-Westphalia, 48149
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Stage Trial to Evaluate Efficacy and Safety of Telitacicept Compared to Placebo in Patients With Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)
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 Phase 3 study is a 2-stage study to evaluate the efficacy and safety of telitacicept compared to placebo in patients with moderately to severely active SLE while receiving SoC treatment in a global patient population with active SLE disease.
- Stage 1: a study to evaluate the efficacy, safety, pharmacokinetics (PK) and PD of two treatment arms of telitacicept compared to placebo in patients with moderately to severely active SLE while receiving SoC treatment.
- Stage 2: a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of telitacicept added to SoC compared to placebo with SoC therapy in patients 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
Also called RC18, RC18-L
Subcutaneous injection weekly for 52 weeks
PlaceboBiological
Subcutaneous injection weekly for 52 weeks
| 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: Biological: 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 at Week 52
Measured: Week 52
Secondary outcomes (6)
SLE Responder Index (SRI-4)
Proportion of subjects achieving an SLE Responder Index (SRI-4) response at Week 24
Measured: Week 24
Achieve and sustain a low dose of corticosteriods
Proportion of subjects achieving the target of corticosteroids reduction through Week 52.
Measured: Weeks 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: 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 posted1 Apr 2022
- Study start20 Jun 2022
- Primary completion6 Jan 2025
- Study completion6 Jan 2025
Why it stopped: 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
- 91 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
- NCT05306574
- Sponsor's protocol ID
- RC18G001
- Status last verified
- Jan 2026
- First submitted
- 23 Mar 2022
- 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, 2-Stage Trial to Evaluate Efficacy and Safety of Telitacicept Compared to Placebo in Patients With Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)
- ClinicalTrials.gov ID
- NCT05306574
- Acronym / sponsor ID
- RC18G001
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, SLE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Vor BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 1 Apr 2022 (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 Phase 3 study is a 2-stage study to evaluate the efficacy and safety of telitacicept compared to placebo in patients with moderately to severely active SLE while receiving SoC treatment in a global patient population with active SLE disease.
- Stage 1: a study to evaluate the efficacy, safety, pharmacokinetics (PK) and PD of two treatment arms of telitacicept compared to placebo in patients with moderately to severely active SLE while receiving SoC treatment.
- Stage 2: a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of telitacicept added to SoC compared to placebo with SoC therapy in patients 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 | Biological: 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 defined by the following:
- Clinical SLEDAI score of ≥4 at Day 0 prior to randomization.
Key exclusion criteria (3 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
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 |
|---|---|---|
| TelitaciceptAlso: RC18, RC18-LSubcutaneous injection weekly for 52 weeks | Biological | Telitacicept |
| PlaceboSubcutaneous injection weekly for 52 weeks | Biological | Placebo |
Primary outcome
SLE Responder Index (SRI-4)
Time frame: Week 52
Proportion of subjects achieving an SLE Responder Index (SRI-4) response at Week 52
6 secondary outcomes
SLE Responder Index (SRI-4)
Time frame: Week 24
Achieve and sustain a low dose of corticosteriods
Time frame: Weeks 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: Week 52
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Time frame: Week 52
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
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.
78 sites in 15 countries: 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 78 sites in 15 countries.
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 3 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: stopped early, 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 78 sites in Poland, United States, Bulgaria, Argentina, Colombia and 10 more countries. 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 stopped early (reason given: Business decision). Results are not available in the source record.
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.