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Systemic Lupus ErythematosusPhase 3POETYK SLE-1NCT05617677

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

A Phase 3 study testing Deucravacitinib in people with Systemic Lupus Erythematosus, run by Bristol-Myers Squibb at 197 sites in 22 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Deucravacitinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
516 participants
Where
197 sitesin 22 countries
Study dates
12 Jan 2023to 13 Nov 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the screening visit.
  • Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE.
  • One of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti dsDNA OR positive anti Smith (anti Sm) as determined by the central laboratory at screening.
  • Total Systemic Lupus Erythematosus Disease Activity Index-2K (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI 2K score ≥ 4 points with joint involvement, and/or cutaneous vasculitis, and/or rash.
  • Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers must be recorded on SLEDAI 2K, if indicated, but do not count toward the points required for screening at entry.
  • At least one SLE background therapy (immunosuppressant and/or antimalarial) is required for ≥ 12 weeks before the screening visit, must be at a stable dose for ≥ 8 weeks before the screening visit, and must remain stable until randomization and throughout study participation.
  • Oral corticosteroid (OCS; prednisone or equivalent) background therapy is permitted but not required. For participants taking OCS, the dose must be stable for ≥ 2 weeks before the screening visit, cannot exceed 30 mg/day at screening, and must remain stable until the Week 4 visit. Participants can be on an OCS as well as an antimalarial and/or an immunosuppressant.

Who cannot join

  • Diagnosis of drug-induced SLE rather than idiopathic SLE.
  • Other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded.
  • SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease are excluded.
  • Active or unstable lupus neuropsychiatric manifestations, including, but not limited to, any condition defined by BILAG A criteria.
  • Active, severe Class III, and IV, lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS.
  • History of congenital or acquired immunodeficiency.
Show all 10Show fewer
  • Known active infection, or any major episode of infection requiring hospitalization or treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics antiviral, antifungal, or antiparasitic agents) within 30 days of randomization, or treatment with oral antimicrobial agents within 2 weeks of randomization.
  • Currently on any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus, invasive bacterial or fungal infections, or atypical mycobacteria).
  • Taking more than 1 immunosuppressant at screening.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

197 sites in 22 countries.

197 sites in 22 countries

United States48 sites

  • Local Institution - 0064

    Allen, Texas, 75013

  • Local Institution - 0204

    Atlanta, Georgia, 30318

  • Local Institution - 0012

    Birmingham, Alabama, 35205

  • Local Institution - 0245

    Charlotte, North Carolina, 28207

  • Local Institution - 0155

    Charlotte, North Carolina, 28211

  • Local Institution - 0249

    Coral Springs, Florida, 33065

  • Local Institution - 0065

    Dallas, Texas, 75390

  • Local Institution - 0099

    Denver, Colorado, 80230

  • Local Institution - 0006

    Detroit, Michigan, 48202

  • Local Institution - 0179

    Eagan, Minnesota, 55121

  • Kaiser Permanente

    Fontana, California, 92335

  • Local Institution - 0088

    Fort Worth, Texas, 76177

  • Local Institution - 0063

    Franklin, Wisconsin, 53132

  • Local Institution - 0010

    Gainesville, Florida, 32610

  • Local Institution - 0250

    Houston, Texas, 77090

  • Local Institution - 0108

    Indianapolis, Indiana, 46202

  • Local Institution - 0247

    La Mesa, California, 91942

  • Local Institution - 0090

    La Palma, California, 90623

  • Local Institution - 0228

    Lawrenceville, Georgia, 30044

  • Local Institution - 0147

    Lawrenceville, Georgia, 30046

  • Local Institution - 0124

    Los Angeles, California, 90095

  • Local Institution - 0219

    Lubbock, Texas, 79415

  • Local Institution - 0180

    Manhasset, New York, 11030

  • Local Institution - 0003

    Memphis, Tennessee, 38119

  • Local Institution - 0087

    Miami, Florida, 33136

  • Local Institution - 0227

    Morton Grove, Illinois, 60053

  • Lake Cumberland Rheumatology

    New Albany, Indiana, 47150

  • Local Institution - 0054

    New Haven, Connecticut, 06510

  • Local Institution - 0225

    New Orleans, Louisiana, 70121

  • Local Institution - 0085

    New York, New York, 10016

  • Local Institution - 0007

    Orlando, Florida, 32806

  • Local Institution - 0229

    Phoenix, Arizona, 85006

  • Local Institution - 0242

    Plantation, Florida, 33317

  • Local Institution - 0009

    Roanoke, Virginia, 24016

  • Local Institution - 0098

    Rochester, New York, 14642

  • Local Institution - 0248

    Sacramento, California, 95817

  • Local Institution - 0253

    San Diego, California, 92128

  • Local Institution - 0128

    Santa Barbara, California, 93108

  • Local Institution - 0077

    Schaumburg, Illinois, 60195

  • Local Institution - 0011

    Seattle, Washington, 98122

  • Local Institution - 0139

    Seattle, Washington, 98195

  • Local Institution - 0246

    Summerville, South Carolina, 29486

  • Local Institution - 0177

    Summit, New Jersey, 07901

  • Local Institution - 0002

    Tamarac, Florida, 33321

  • Local Institution - 0165

    Tampa, Florida, 33614

  • Local Institution - 0159

    The Bronx, New York, 10467

  • Local Institution - 0005

    The Woodlands, Texas, 77382

  • Local Institution - 0193

    Tucson, Arizona, 85724

Other trials in United States

China32 sites

  • Local Institution - 0153

    Baoding, Hebei, 071030

  • Local Institution - 0070

    Beijing, Beijing Municipality, 100730

  • Local Institution - 0110

    Bengbu, Anhui, 233017

  • Local Institution - 0044

    Changsha, Hunan, 410008

  • Local Institution - 0129

    Changzhou, Jiangsu, 213003

  • Local Institution - 0116

    Chengdu, Sichuan, 610041

  • Local Institution - 0029

    Guangzhou, Guangdong, 510000

  • Local Institution - 0051

    Guangzhou, Guangdong, 510080

  • Local Institution - 0080

    Guangzhou, Guangdong, 510120

  • Local Institution - 0132

    Hangzhou, Zhejiang, 310003

  • Local Institution - 0089

    Hohhot, Inner Mongolia, 010050

  • Local Institution - 0149

    Jinan, Shandong, 250001

  • Local Institution - 0031

    Jiujiang, Jiangxi, 332000

  • Local Institution - 0133

    Luoyang, Henan, 471003

  • Local Institution - 0071

    Nanchang, Jiangxi, 330006

  • Local Institution - 0117

    Nanchang, Jiangxi, 330006

  • Local Institution - 0220

    Nanchang, Jiangxi, 330006

  • Local Institution - 0028

    Pingxiang, Jiangxi, 337055

  • Local Institution - 0079

    Shanghai, Shanghai Municipality, 200025

  • Local Institution - 0045

    Shanghai, Shanghai Municipality, 200040

  • Local Institution - 0049

    Shanghai, Shanghai Municipality, 200127

  • Local Institution - 0039

    Shenyang, Liaoning, 110001

  • Local Institution - 0092

    Shenyang, Liaoning, 110004

  • Local Institution - 0037

    Shenzhen, Guangdong, 518020

  • Local Institution - 0158

    Taiyuan, 030032

  • Local Institution - 0053

    Tianjin, Tianjin Municipality, 300052

  • Local Institution - 0043

    Ürümqi, Xinjiang, 830001

  • Local Institution - 0135

    Wenzhou, Zhejiang, 325000

  • Local Institution - 0137

    Wuhan, Hubei, 430022

  • Local Institution - 0107

    Xiamen, Fujian, 361003

  • Local Institution - 0023

    Zhengzhou, Henan, 450000

  • Local Institution - 0021

    Zhuzhou, Hunan, 412007

Other trials in China

Brazil12 sites

  • Local Institution - 0042

    Belo Horizonte, Minas Gerais, 30150-221

  • Local Institution - 0185

    Campinas, São Paulo, 13015-001

  • Local Institution - 0190

    Curitiba, Paraná, 80730-150

  • Local Institution - 0041

    Juiz de Fora, Minas Gerais, 36010-570

  • Local Institution - 0096

    Lago Sul, Federal District, 71635580

  • Local Institution - 0181

    Porto Alegre, Rio Grande do Sul, 90610000

  • Local Institution - 0187

    Ribeirão Preto, São Paulo, 14051-140

  • Local Institution - 0186

    Rio de Janeiro, 20551-030

  • Local Institution - 0224

    Salvador, Estado de Bahia, 40150-150

  • Local Institution - 0066

    São José do Rio Preto, São Paulo, 15090000

  • Local Institution - 0191

    São Paulo, São Paulo, 04038-002

  • Local Institution - 0125

    São Paulo, 05403-000

Other trials in Brazil

Poland11 sites

  • Local Institution - 0211

    Bełchatów, Łódź Voivodeship, 97-400

  • Local Institution - 0035

    Bialystok, 15-707

  • Local Institution - 0040

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • Local Institution - 0047

    Katowice, Silesian Voivodeship, 40-081

  • Local Institution - 0033

    Krakow, Lesser Poland Voivodeship, 30-363

  • Velocity Clinical Research, Lublin

    Lublin, 20-362

  • Local Institution - 0034

    Nadarzyn, Masovian Voivodeship, 05-830

  • Local Institution - 0036

    Poznan, Greater Poland Voivodeship, 60-218

  • Local Institution - 0212

    Poznan, 60-702

  • Local Institution - 0164

    Warsaw, Masovian Voivodeship, 02-118

  • Local Institution - 0166

    Warsaw, Masovian Voivodeship, 02-637

Other trials in Poland

Argentina10 sites

  • Local Institution - 0013

    Buenos Aires, Buenos Aires F.D., C1121ABE

  • Local Institution - 0032

    Buenos Aires, 1123

  • Local Institution - 0240

    Buenos Aires, C1023AAB

  • Local Institution - 0022

    Buenos Aires, C1221ADC

  • Local Institution - 0140

    Buenos Aires, CP1280AEB

  • Local Institution - 0020

    CABA, Buenos Aires F.D., 1406

  • Local Institution - 0138

    Córdoba, 5004

  • Local Institution - 0017

    Mendoza, 5500

  • Local Institution - 0078

    Quilmes, Buenos Aires, 1878

  • Local Institution - 0123

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Mexico10 sites

  • Local Institution - 0018

    Chihuahua City, 31000

  • Local Institution - 0082

    León, Guanajuato, 37000

  • Local Institution - 0015

    Mexicali, Estado de Baja California, 21100

  • Local Institution - 0026

    Mexico City, Mexico City, 01120

  • Local Institution - 0027

    Mexico City, Mexico City, 03720

  • Local Institution - 0016

    Mexico City, Mexico City, 06700

  • Local Institution - 0050

    Mexico City, Mexico City, 06700

  • Local Institution - 0112

    Mexico City, Mexico City, 14080

  • Local Institution - 0083

    Puebla City, 72160

  • Local Institution - 0024

    Zapopan, Jalisco, 45116

Other trials in Mexico

Romania10 sites

  • Local Institution - 0148

    Bucharest, Bucharest, 011053

  • Local Institution - 0076

    Bucharest, Bucharest, 011172

  • Local Institution - 0152

    Bucharest, Bucharest, 014142

  • Local Institution - 0141

    Bucharest, Bucharest, 020125

  • Local Institution - 0215

    Bucharest, Bucharest, 041303

  • Local Institution - 0210

    Bucharest, Bucharest, 30463

  • Local Institution - 0142

    Craiova, Dolj, 200347

  • Local Institution - 0216

    Iași, Iaşi, 700127

  • Local Institution - 0094

    Râmnicu Vâlcea, Vâlcea County, 247065

  • Local Institution - 0143

    Timișoara, 300766

Other trials in Romania

Germany8 sites

  • Local Institution - 0195

    Chemnitz, 09117

  • Local Institution - 0061

    Cologne, 50937

  • Local Institution - 0146

    Dresden, Saxony, 01307

  • Local Institution - 0120

    Erlangen, 91054

  • Local Institution - 0151

    Lübeck, Schleswig-Holstein, 23538

  • Local Institution - 0176

    Munich, Bavaria, 80336

  • Local Institution - 0111

    Planegg, 82152

  • Local Institution - 0109

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Italy8 sites

  • Local Institution - 0069

    Brescia, 25123

  • Local Institution - 0095

    Milan, Lombardy, 20122

  • Local Institution - 0072

    Milan, 20132

  • Local Institution - 0154

    Naples, 80131

  • Local Institution - 0097

    Padova, Veneto, 35128

  • Local Institution - 0060

    Pisa, Tuscany, 56126

  • Local Institution - 0084

    Rome, Lazio, 00161

  • Local Institution - 0161

    Verona, 37134

Other trials in Italy

Colombia7 sites

  • Local Institution - 0056

    Barranquilla, Atlántico, 080002

  • Local Institution - 0100

    Bogotá, 110221

  • Local Institution - 0170

    Bogotá, 110231

  • Local Institution - 0086

    Bucaramanga, Santander Department, 680003

  • Local Institution - 0093

    Cali, 760035

  • Local Institution - 0057

    Chía, 250001

  • Local Institution - 0174

    Medellín, Antioquia, 050021

Other trials in Colombia

India7 sites

  • Local Institution - 0200

    Ahmedabad, Gujarat, 380015

  • Local Institution - 0202

    Bengaluru, Karnataka, 560010

  • Local Institution - 0208

    Gurugram, Haryana, 122001

  • Local Institution - 0222

    Hyderabad, Telangana, 500038

  • Local Institution - 0205

    Hyderabad, Telangana, 500082

  • Local Institution - 0243

    Surat, Gujarat, 395010

  • Local Institution - 0213

    Vizianagaram, Andhra Pradesh, 0

Other trials in India

Canada5 sites

  • Local Institution - 0126

    Calgary, Alberta, T2N 4N1

  • Local Institution - 0160

    Hamilton, Ontario, L8S 4K1

  • Local Institution - 0114

    London, Ontario, N6A 4V2

  • Local Institution - 0136

    Rimouski, Quebec, G5L 5T1

  • Local Institution - 0115

    Toronto, Ontario, M5T 2S8

Other trials in Canada

France4 sites

  • Local Institution - 0173

    Le Kremlin-Bicêtre, 94270

  • Local Institution - 0068

    Nantes, Loire-Atlantique, 44093 Cedex 1

  • Local Institution - 0150

    Strasbourg, Alsace, 67091

  • Local Institution - 0156

    Tours, 37032

Other trials in France

Ireland4 sites

  • Local Institution - 0130

    Cork, T12 E8YV

  • Local Institution - 0157

    Dublin, D08 E9P6

  • Local Institution - 0172

    Dublin, D15 X40D

  • Local Institution - 0119

    Manorhamilton, Leitrim, 0

Other trials in Ireland

Peru4 sites

  • Local Institution - 0199

    Arequipa, 05154

  • Local Institution - 0104

    Lima, 15046

  • Local Institution - 0122

    Lima, 15047

  • Local Institution - 0103

    Lima, 33

Other trials in Peru

South Korea4 sites

  • Local Institution - 0102

    Gwangju, Kwangju-Kwangyǒkshi, 61469

  • Local Institution - 0144

    Seoul, Seoul-teukbyeolsi [Seoul], 06591

  • Local Institution - 0169

    Seoul, 04763

  • Local Institution - 0101

    Suwon, Kyǒnggi-do, 16499

Other trials in South Korea

Bulgaria3 sites

  • Local Institution - 0163

    Plovdiv, 4000

  • Local Institution - 0217

    Sofia, 1407

  • Local Institution - 0162

    Sofia, 1784

Other trials in Bulgaria

Puerto Rico3 sites

  • Local Institution - 0203

    Caguas, 00725

  • Local Institution - 0252

    San Juan, 00909

  • Local Institution - 0197

    San Juan, 00917

Other trials in Puerto Rico

Turkey (Türkiye)3 sites

  • Local Institution - 0184

    Ankara, 06560

  • Local Institution - 0168

    Istanbul, 34098

  • Local Institution - 0189

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Moldova2 sites

  • Local Institution - 0238

    Chisinau, Chișinău, MD-2051

  • Local Institution - 0236

    Chisinau, 2025

Other trials in Moldova

Hong Kong1 site

  • Local Institution - 0067

    Tuenmen, 999077

Other trials in Hong Kong

Lithuania1 site

  • Local Institution - 0167

    Kaunas, Kaunas County, LT-50161

Other trials in Lithuania

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-1)

The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.

Being tested
Deucravacitinib, Placebo
Keywords
Autoimmune Diseases, Immune System Diseases, Connective Tissue Diseases, Immune-mediated Diseases, Active Systemic Lupus Erythematosus, Lupus, SLE, Deucravacitinib, Tyk2, POETYK, POETYK SLE
Medical subject headings
Lupus Erythematosus, Systemic, Autoimmune Diseases, Immune System Diseases, Connective Tissue Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DeucravacitinibDrug

    Specified dose on specified days

  • PlaceboOther

    Specified dose on specified days

Study groups in NCT05617677
Study groupRoleWhat they receive
Arm 1: DeucravacitinibExperimentalNot described
Receives: Drug: Deucravacitinib
Arm 2: PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response

    Measured: At week 52

Secondary outcomes (15)

  1. Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response

    Measured: At week 52

  2. Proportion of participants who achieve both SRI(4) and BICLA (dual responders)

    Measured: At week 52

  3. Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score

    Measured: At week 52

  4. Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS)

    Measured: At week 52

  5. Proportion of participants with ≥ 6 active (tender + swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints

    Measured: At week 52

  6. Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue

    Measured: At week 52

  7. Proportion of participants with oral corticosteroid (OCS) ≥ 7.5 mg/day of prednisone at baseline who are receiving ≤ 5 mg/day of prednisone at Week (Wk) 40 which is maintained through Wk52 and who achieve an SRI(4) response at Wk52.

    Measured: At Week 52

  8. Number of participants with adverse events (AEs)

    Measured: Up to 156 weeks

  9. Number of participants with serious adverse events (SAEs)

    Measured: Up to 156 weeks

  10. Number of participants with AEs leading to discontinuation of treatment

    Measured: Up to 156 weeks

  11. Number of participants with AEs leading to study discontinuation

    Measured: Up to 156 weeks

  12. Number of participants with target adverse events of special interest (AESIs)

    Measured: Up to 156 weeks

  13. Number of participants with laboratory abnormalities

    Measured: Up to 156 weeks

  14. Number of participants with electrocardiogram (ECG) abnormalities

    Measured: Up to 156 weeks

  15. Number of participants with vital sign abnormalities

    Measured: Up to 156 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2022
  2. Study start12 Jan 2023
  3. Primary completion19 Oct 2026 (estimated)
  4. Study completion13 Nov 2028 (estimated)

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
516 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05617677
Sponsor's protocol ID
IM011-246
Other IDs
2022-500699-76
Acronym
POETYK SLE-1
Status last verified
Nov 2025
First submitted
8 Nov 2022
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Publications

  • Kahlenberg JM, Wu C, Vital E, Catlett IM, Crow MK, Sanz I, Saxena A, Arriens C, Hobar C, Hu Y. Pharmacodynamic analysis of TYK2 inhibition by deucravacitinib: results from the phase 2 PAISLEY SLE trial in patients with active systemic lupus erythematosus. Ann Rheum Dis. 2026 Aug 27:S0003-4967(26)00437-1. doi: 10.1016/j.ard.2026.07.013. Online ahead of print.

    PubMed 42660739

  • Arriens C, Morand EF, Askanase AD, Furie R, van Vollenhoven RF, Tanaka Y, Connors K, Davey M, Young K, Franchin G, Meier R, Shah V, de Oliveria CL, Hobar C. Design of Two Randomized, Placebo-Controlled, Phase 3 Trials of Deucravacitinib, an Oral, Selective, Allosteric TYK2 Inhibitor, in Systemic Lupus Erythematosus. Adv Ther. 2025 Nov;42(11):5830-5844. doi: 10.1007/s12325-025-03299-0. Epub 2025 Sep 8.

    PubMed 40920289

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Deucravacitinib in people with Systemic Lupus Erythematosus, run by Bristol-Myers Squibb at 197 sites in 22 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 7 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 197 sites in United States, China, Brazil, Poland, Argentina and 17 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?

This study is still under way. Results are not available in the source record yet.

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?

Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response (time frame: At week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05617677, which also lists 2 linked publications.

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 Dec 2025.

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