Systemic Lupus ErythematosusPhase 2PREVAIL-2NCT05087628
PRV-3279-2a Trial in Systemic Lupus
A Phase 2 study testing PRV-3279 in people with Systemic Lupus Erythematosus, run by Provention Bio, a Sanofi Company at 36 sites in 4 countries.
Trial summary
The PREVAIL-2 study was designed to assess the safety and potential efficacy of PRV-3279 in flare prevention in systemic lupus erythematosus (SLE) participants with active disease after amelioration induced by corticosteroid treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- PRV-3279
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 36 sitesin 4 countries
- Study dates
- 20 Jan 2022to 24 Jun 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of SLE for at least 6 months prior to the Screening visit
- Meet the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) criteria for SLE at Screening
- Have moderate to severe disease activity despite stable standard-of-care medication defined as:
- At screening: hSLEDAI score ≥6 (≥4 points of which must come from non-serological finding), OR at least one BILAG A or one B score; At randomization: ≥4-point drop in hSLEDAI, OR one BILAG letter grade improvement in at least one A or B score present at Screening, and investigator or central adjudication committee (CAC) rating of definite improvement or major or complete improvement
- Able and willing to stop all lupus treatments, except antimalarials, corticosteroids (prednisone equivalent ≤ 10 mg), and NSAIDs
Who cannot join
- Active lupus nephritis or active central nervous system manifestations of SLE
- Other inflammatory or autoimmune diseases that, in the opinion of the Investigator or CAC, may confound efficacy evaluations
- Common variable immunodeficiency syndrome or any other clinically significant immunodeficiency
- Known COVID-19 infection in the 4 weeks before Screening or positive SARS-CoV-2 RNA test
- Received a live attenuated vaccine within 2 months of Screening, received a non-live or mRNA vaccine within 2 weeks of Screening, or expecting to receive any vaccine during the study period
- Any recent infection requiring antibiotics within two weeks of Screening or any recent infection requiring IV antibiotics or hospitalization within 1 month of Screening
Show all 11Show fewer
- Any condition for which, in the opinion of the Investigator or CAC, participation in the study would not be in the best interest of the patient (e.g., compromise their well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participated in any interventional clinical trial within 42 days prior to Screening or within five half-lives of the investigational product, whichever is longer
- Received rituximab or equivalent treatment that depletes B cells within 6 months of Screening unless return of B cells to pre-treatment value or normal range can be demonstrated.
- Received tumor necrosis factor inhibitors, interleukin antagonists, or other biologics, including belimumab, within 42 days or five half-lives of the agent, whichever is longer.
- Received IV immunoglobulin (IVIG) or IV cyclophosphamide within 2 months, prednisone ≥ 100 mg/day for more than 30 days within 2 months, or plasmapheresis within two months of the Screening visit.
Trial locations and contacts
36 sites in 4 countries.
36 sites in 4 countries
United States22 sites
Medvin Clinical Research - Apple Valley- Site Number : 133
Apple Valley, California, 92307
Highlands Advanced Rheumatology & Arthritis Center- Site Number : 116
Avon Park, Florida, 33825
Medvin Clinical Research - Covina - West San Bernardino Road- Site Number : 106
Covina, California, 91722
Center for Rheumatology, Immunology and Arthritis- Site Number : 109
Fort Lauderdale, Florida, 33309
Grapevine Rheumatology Clinic- Site Number : 103
Grapevine, Texas, 76051
Accurate Clinical Management - Greenhouse Road- Site Number : 104
Houston, Texas, 77084
Accurate Clinical Research - Houston Resource Parkway- Site Number : 105
Houston, Texas, 77089
University of California San Diego - La Jolla- Site Number : 108
La Jolla, California, 92037
University of California Los Angeles Medical Center- Site Number : 122
Los Angeles, California, 90095
Facey Medical Group - Los Angeles- Site Number : 126
Los Angeles, California, 91345
Ochsner Medical Center - Jefferson Highway- Site Number : 113
New Orleans, Louisiana, 70121
Millennium Research- Site Number : 111
Ormond Beach, Florida, 32174
Yale University School of Medicine- Site Number : 125
Pittsburgh, Pennsylvania, 15213-2536
Desert Medical Advances- Site Number : 114
Rancho Mirage, California, 92270
Sun Research Institute- Site Number : 121
San Antonio, Texas, 78215
D&H Tamarac Research Center- Site Number : 123
Tamarac, Florida, 33321
Florida Hospital Tampa- Site Number : 107
Tampa, Florida, 33613
University of Toledo Medical Center- Site Number : 110
Toledo, Ohio, 43614
Revival Research Corporation - Michigan - ClinEdge - PPDS- Site Number : 124
Troy, Michigan, 48084
Medvin Clinical Research - Tujunga- Site Number : 119
Tujunga, California, 91042
Vernon Hills Medical Associates- Site Number : 128
Vernon Hills, Illinois, 60061
Medvin Clinical Research - Whittier- Site Number : 118
Whittier, California, 90602
China9 sites
Investigational Site Number : 310
Beijing, 100050
Investigational Site Number : 301
Beijing, 100730
Investigational Site Number : 309
Changchun, 130021
Investigational Site Number : 302
Guangzhou, 510080
Investigational Site Number : 303
Nanchang, 330006
Investigational Site Number : 307
Nanjing, 210008
Investigational Site Number : 306
Shanghai, 200127
Investigational Site Number : 305
Tianjin, 300052
Investigational Site Number : 304
Wuhan, 430030
Puerto Rico3 sites
Centro Reumatologico de Caguas- Site Number : 112
Caguas, 00725
Private Practice - Dr. Karina Vila Rivera- Site Number : 117
San Juan, 00917
BCR Medical Center Inc.- Site Number : 129
San Juan, 909
Hong Kong2 sites
Investigational Site Number : 202
Pok Fu Lam, 999077
Investigational Site Number : 201
Tuenmen, 999077
About this study
Official title: Phase 2a, Randomized, Double-blind, Placebo-controlled Trial of PRV-3279 EVAluation In Lupus
The PREVAIL-2 study was designed to assess the safety and potential efficacy of PRV-3279 in flare prevention in systemic lupus erythematosus (SLE) participants with active disease after amelioration induced by corticosteroid treatment.
Read the detailed description
This was a randomized, double-blind, placebo-controlled study in adult participants with active SLE. Approximately 100 eligible participants were randomized at a 1:1 ratio to receive treatment with either PRV-3279 or placebo.
Eligible participants included male or female adults, 18 to 70 years of age, with a diagnosis of SLE for at least 6 months.
The study drug was administered every 4 weeks for 20 weeks in a double-blind fashion, followed by an 8-week safety follow-up period.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- PRV-3279, Placebo
- Keywords
- SLE, Systemic Lupus Erythematosus
- 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.
PRV-3279Biological
Also called SAR446811
Bi-specific antibody-based molecule
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| PRV-3279 | Experimental | Sterile solution for intravenous administration, every 4 weeks Receives: Biological: PRV-3279 |
| Placebo | Experimental | Sterile solution for intravenous administration, every 4 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Maintained the Improvement in Systemic Lupus Erythematosus (SLE) Disease Activity From Baseline to Week 24
Improvement in SLE disease activity:no lupus flare during baseline to Week 24. Lupus flare:Investigator's assessment that SLE activity met Lupus Foundation of America international consensus definition for flare (defined as measurable increase in disease activity in 1 or more organ systems involving new or worse clinical signs and symptoms and/or laboratory measurements,must be considered clinically significant by the assessor,and usually there would be at least consideration of a change or an increase in treatment);a score of "definite worsening" or "severe worsening" on Clinician's Global Impression of Change;and at least 1 of following occurrences: an increase of >=4 points from baseline in hybrid Safety of Estrogens in Lupus Erythematosus National Assessment- Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score (hSLEDAI),or >=1 organ with an A score (severe) or B score (moderate) item rated new or worse on British Isles Lupus Assessment Group (BILAG) Index.
Measured: Baseline (Day 1) to Week 24
Secondary outcomes (8)
Time to Treatment Failure From Baseline to Week 24
Treatment failure was defined compared to baseline as the occurrence of an SLE flare (as defined in the primary outcome measure #1); or missing 2 consecutive doses or 3 or more total doses of the study treatment for any reason; or initiation of a new SLE medication; or increased dose of current SLE medication, with the exception of nonsteroidal anti-inflammatory drugs; or participant withdrawal from the study before the Week 24 visit. Baseline was defined as the last non-missing value prior to the first dose of study treatment. Estimations were based on the Kaplan-Meier method.
Measured: Baseline (Day 1) to Week 24
Percentage of Participants Who Met European League Against Rheumatism (EULAR)-Recommended Goal of Low Disease Responders From Baseline Until Week 24
EULAR recommended goal of low disease responders were defined as participants who met either of following criteria: hSLEDAI score <3 (lower disease activity) or all BILAG scores were C (mild disease activity), or D (no disease activity in an organ previously affected) or E (organ inactive and never previously active). Baseline was defined as the last non-missing value prior to the first dose of study treatment. Percentages are rounded off to the tenth decimal place.
Measured: Baseline (Day 1) and Weeks 4, 8, 12, 16, 20 and 24
Change From Screening Until Week 24 in the Physical Component Score (PCS) in the Short Form 36 (SF-36) Health Survey
SF-36 health survey consisted of 36 items which measured 8 subscales relevant to quality of life (QOL):physical functioning(PF),general health(GH),mental health(MH),vitality(VT),role physical(RP),role emotional(RE),bodily pain(BP), and social functioning(SF).Score range for each of 8 subscales was from 0(maximum disability) to 100(no disability);higher scores indicated good health condition. Responses on SF-36 were used to calculate 2 summary scores: PCS contributed by PF,RP,BP and GH and mental component summary(MCS) contributed by MH,RE, SF and VT. Summations of item scores of same domain gave sub-scale scores, which were transformed to calculate summary scores of PCS and MCS. Both PCS and MCS score ranges from 0(worst) to 100(best); higher scores indicated less disability and better QoL. Change from screening (post-screening value minus screening value) until Week 24 in PCS in SF-36 health survey is presented. Baseline:last non-missing value prior to first dose of study treatment.
Measured: Screening (Days -42 to -1), Baseline (Day 1) and Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants Who Met the Criteria for Systemic Lupus Erythematosus Responder Index-4 (SRI-4) From Baseline Until Week 24
SRI-4 was defined as a hSLEDAI score decrease of >=4 points; and no new organs with a BILAG A (severe) score; and no more than 1 new organ with a BILAG B (moderate) score; and no SELENA-SLEDAI physician's global assessment (ssPGA) score increase of >0.3 points. Baseline was defined as the last non-missing value prior to the first dose of study treatment. Percentages are rounded off to the tenth decimal place.
Measured: Baseline (Day 1) and Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants Who Met the British Isles Lupus Assessment Group-Based Combined Lupus Assessment (BICLA) Criteria From Baseline Until Week 24
BICLA criteria was defined as reduction by >=1 grade in all organs with BILAG A (severe) or B (moderate) scores; and no worsening of SLEDAI or other BILAG organs; and no ssPGA score increase of >=0.3 points. Baseline was defined as the last non-missing value prior to the first dose of study treatment. Percentages are rounded off to the tenth decimal place.
Measured: Baseline (Day 1) and Weeks 4, 8, 12, 16, 20 and 24
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), TEAEs Leading to Treatment Discontinuation and Treatment-Emergent Adverse Events of Special Interest (TEAESIs)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or any other medically important event. A TEAE was defined as an AE that developed, worsened or became serious during the TE period. An AESI was defined as a TEAE including SAE, that were of scientific and medical concern specific to PRV-3279, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was considered appropriate.
Measured: From first dose of study treatment (Day 1) up to 56 days post last dose of study treatment, up to 29.1 weeks
Serum Concentrations of PRV-3279
Serum samples were collected at specified timepoints to evaluate serum concentration of PRV-3279.
Measured: Pre-dose and 2 hours post-dose on Days 1, 29, 57, 86, 113, 141, 169 and 197; 24, 48, 72, 168, 336 hours post-dose on Days 1 and 141
Number of Participants With Anti-Drug Antibodies (ADAs) Against PRV-3279
Blood samples were collected at specified timepoints to evaluate the presence of ADA against PRV-3279. Treatment-emergent ADA was defined as at least 1 treatment-induced or treatment-boosted ADA at any time after first study treatment administration. Treatment-induced ADA was defined as ADA that developed at any time after first study treatment administration and without pre-existing ADA (including participants without pre-treatment samples). Treatment-boosted ADA was defined as pre-existing ADA that boosted during the TE period to a significant higher titer than the baseline. Number of participants with treatment-emergent ADA is presented.
Measured: From first dose of study treatment (Day 1) up to 56 days post last dose of study treatment, up to 29.1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start20 Jan 2022
- Primary completion14 May 2024
- Study completion24 Jun 2024
Why it stopped: Termination for Strategic Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Provention Bio, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087628
- Sponsor's protocol ID
- PRV-3279-2a
- Other IDs
- ACT18113
- Acronym
- PREVAIL-2
- Status last verified
- Mar 2026
- First submitted
- 27 Sep 2021
- Last updated
- 3 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a, Randomized, Double-blind, Placebo-controlled Trial of PRV-3279 EVAluation In Lupus
- ClinicalTrials.gov ID
- NCT05087628
- Acronym / sponsor ID
- PREVAIL-2 / PRV-3279-2a
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- SLE, Systemic Lupus Erythematosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination for Strategic Reasons
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Provention Bio, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Posted 3 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PREVAIL-2 study was designed to assess the safety and potential efficacy of PRV-3279 in flare prevention in systemic lupus erythematosus (SLE) participants with active disease after amelioration induced by corticosteroid treatment.
Detailed description
This was a randomized, double-blind, placebo-controlled study in adult participants with active SLE. Approximately 100 eligible participants were randomized at a 1:1 ratio to receive treatment with either PRV-3279 or placebo.
Eligible participants included male or female adults, 18 to 70 years of age, with a diagnosis of SLE for at least 6 months.
The study drug was administered every 4 weeks for 20 weeks in a double-blind fashion, followed by an 8-week safety follow-up period.
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 |
|---|---|---|
| PRV-3279 | Experimental | Biological: PRV-3279Sterile solution for intravenous administration, every 4 weeks |
| Placebo | Experimental | Other: PlaceboSterile solution for intravenous administration, every 4 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A diagnosis of SLE for at least 6 months prior to the Screening visit
- Meet the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) criteria for SLE at Screening
- Have moderate to severe disease activity despite stable standard-of-care medication defined as:
- At screening: hSLEDAI score ≥6 (≥4 points of which must come from non-serological finding), OR at least one BILAG A or one B score; At randomization: ≥4-point drop in hSLEDAI, OR one BILAG letter grade improvement in at least one A or B score present at Screening, and investigator or central adjudication committee (CAC) rating of definite improvement or major or complete improvement
- Able and willing to stop all lupus treatments, except antimalarials, corticosteroids (prednisone equivalent ≤ 10 mg), and NSAIDs
Key exclusion criteria (11 listed)
- Active lupus nephritis or active central nervous system manifestations of SLE
- Other inflammatory or autoimmune diseases that, in the opinion of the Investigator or CAC, may confound efficacy evaluations
- Common variable immunodeficiency syndrome or any other clinically significant immunodeficiency
- Known COVID-19 infection in the 4 weeks before Screening or positive SARS-CoV-2 RNA test
- Received a live attenuated vaccine within 2 months of Screening, received a non-live or mRNA vaccine within 2 weeks of Screening, or expecting to receive any vaccine during the study period
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 |
|---|---|---|
| PRV-3279Also: SAR446811Bi-specific antibody-based molecule | Biological | PRV-3279 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Percentage of Participants Who Maintained the Improvement in Systemic Lupus Erythematosus (SLE) Disease Activity From Baseline to Week 24
Time frame: Baseline (Day 1) to Week 24
Improvement in SLE disease activity:no lupus flare during baseline to Week 24. Lupus flare:Investigator's assessment that SLE activity met Lupus Foundation of America international consensus definition for flare (defined as measurable increase in disease activity in 1 or more organ systems involving new or worse clinical signs and symptoms and/or laboratory measurements,must be considered clinically significant by the assessor,and usually there would be at least consideration of a change or an increase in treatment);a score of "definite worsening" or "severe worsening" on Clinician's Global Impression of Change;and at least 1 of following occurrences: an increase of >=4 points from baseline in hybrid Safety of Estrogens in Lupus Erythematosus National Assessment- Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score (hSLEDAI),or >=1 organ with an A score (severe) or B score (moderate) item rated new or worse on British Isles Lupus Assessment Group (BILAG) Index.
8 secondary outcomes
Time to Treatment Failure From Baseline to Week 24
Time frame: Baseline (Day 1) to Week 24
Percentage of Participants Who Met European League Against Rheumatism (EULAR)-Recommended Goal of Low Disease Responders From Baseline Until Week 24
Time frame: Baseline (Day 1) and Weeks 4, 8, 12, 16, 20 and 24
Change From Screening Until Week 24 in the Physical Component Score (PCS) in the Short Form 36 (SF-36) Health Survey
Time frame: Screening (Days -42 to -1), Baseline (Day 1) and Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants Who Met the Criteria for Systemic Lupus Erythematosus Responder Index-4 (SRI-4) From Baseline Until Week 24
Time frame: Baseline (Day 1) and Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants Who Met the British Isles Lupus Assessment Group-Based Combined Lupus Assessment (BICLA) Criteria From Baseline Until Week 24
Time frame: Baseline (Day 1) and Weeks 4, 8, 12, 16, 20 and 24
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), TEAEs Leading to Treatment Discontinuation and Treatment-Emergent Adverse Events of Special Interest (TEAESIs)
Time frame: From first dose of study treatment (Day 1) up to 56 days post last dose of study treatment, up to 29.1 weeks
Serum Concentrations of PRV-3279
Time frame: Pre-dose and 2 hours post-dose on Days 1, 29, 57, 86, 113, 141, 169 and 197; 24, 48, 72, 168, 336 hours post-dose on Days 1 and 141
Number of Participants With Anti-Drug Antibodies (ADAs) Against PRV-3279
Time frame: From first dose of study treatment (Day 1) up to 56 days post last dose of study treatment, up to 29.1 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Clinical Sciences & Operations study director
Sanofi
36 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRV-3279 in people with Systemic Lupus Erythematosus, run by Provention Bio, a Sanofi Company at 36 sites in 4 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 5 inclusion and 11 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 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, China, Puerto Rico, Hong Kong. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Maintained the Improvement in Systemic Lupus Erythematosus (SLE) Disease Activity From Baseline to Week 24 (time frame: Baseline (Day 1) to Week 24). 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 3 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.