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Systemic Lupus ErythematosusPhase 3POETYK SLE-2NCT05620407

A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus

A Phase 3 study testing Deucravacitinib in people with Systemic Lupus Erythematosus, run by Bristol-Myers Squibb at 180 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
513 participants
Where
180 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.
  • 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).
Show all 9Show fewer
  • Taking more than 1 immunosuppressant at screening.
  • In Japan only: Participants with positive result of β - D-glucan assay.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

180 sites in 22 countries.

180 sites in 22 countries

United States39 sites

  • Emory University School of Medicine- Grady Campus

    Atlanta, Georgia, 30303

  • Local Institution - 0060

    Boston, Massachusetts, 02114

  • Local Institution - 0056

    Boston, Massachusetts, 02215

  • Local Institution - 0069

    Brooklyn, New York, 11201

  • Local Institution - 0081

    Charleston, South Carolina, 29425

  • Local Institution - 0178

    Charlotte, North Carolina, 28210

  • Local Institution - 0213

    Clearwater, Florida, 33765

  • Local Institution - 0005

    Cleveland, Ohio, 44106

  • Local Institution - 0001

    Colleyville, Texas, 76034

  • Local Institution - 0133

    Danville, Virginia, 24541

  • Local Institution - 0164

    El Paso, Texas, 79902

  • Local Institution - 0225

    Florence, South Carolina, 29501

  • Local Institution - 0152

    Grand Blanc, Michigan, 48439

  • Local Institution - 0217

    Great Neck, New York, 11021

  • Local Institution - 0002

    Jackson, Tennessee, 38305

  • Local Institution - 0059

    Jacksonville, Florida, 32256

  • Local Institution - 0169

    Katy, Texas, 77494

  • Local Institution - 0063

    La Jolla, California, 92037

  • Local Institution - 0241

    La Mesa, California, 91942

  • Local Institution - 0216

    Las Vegas, Nevada, 89102

  • Local Institution - 0075

    Margate, Florida, 33063

  • Local Institution - 0137

    Marietta, Georgia, 30060

  • Local Institution - 0231

    New Orleans, Louisiana, 70112

  • Local Institution - 0150

    New York, New York, 10021

  • Local Institution - 0102

    New York, New York, 10032

  • Local Institution - 0007

    Oakland Park, Florida, 33334

  • Local Institution - 0043

    Oklahoma City, Oklahoma, 73104

  • Local Institution - 0089

    Orland Park, Illinois, 60467

  • Local Institution - 0165

    Paramus, New Jersey, 07652

  • Local Institution - 0205

    Pittsburgh, Pennsylvania, 15224

  • Local Institution - 0239

    Plant City, Florida, 33160

  • Local Institution - 0072

    Rochester, Minnesota, 55905

  • Local Institution - 0242

    San Diego, California, 92128

  • Local Institution - 0143

    San Leandro, California, 94578

  • Local Institution - 0147

    Santa Monica, California, 90404

  • Local Institution - 0041

    Skokie, Illinois, 60076

  • Local Institution - 0145

    Syracuse, New York, 13210

  • Local Institution - 0201

    Temple, Texas, 76508

  • Local Institution - 0084

    Worcester, Massachusetts, 01605

Other trials in United States

Japan30 sites

  • Local Institution - 0082

    Asahikawa, Hokkaido, 0708644

  • Local Institution - 0173

    Bunkyo-ku, Tokyo, 113-8519

  • Local Institution - 0046

    Bunkyo-ku, Tokyo, 1138431

  • Local Institution - 0047

    Chiba, Chiba, 260-8712

  • Local Institution - 0086

    Eiheiji-cho,Yoshida-gun, Fukui, 910-1193

  • Local Institution - 0227

    Fukuoka, 812-8582

  • Local Institution - 0050

    Fukushima, 960-1295

  • Local Institution - 0167

    Gifu, 501-1112

  • Local Institution - 0022

    Kawagoe, Saitama, 350-8550

  • Local Institution - 0162

    Kita, Kagawa-ken, 761-0701

  • Local Institution - 0117

    Kitakyushu, Fukuoka, 807-8556

  • Local Institution - 0045

    Meguro-ku, Tokyo, 1538515

  • Local Institution - 0126

    Nagasaki, 852-8501

  • Local Institution - 0053

    Nagoya, Aichi-ken, 457-8511

  • Local Institution - 0156

    Nagoya, Aichi-ken, 466-8560

  • Local Institution - 0131

    Niigata, 951-8520

  • Local Institution - 0085

    Okayama, 700-8558

  • Local Institution - 0108

    Osaka, 545-8586

  • Local Institution - 0111

    Sagamihara, Kanagawa, 252-0375

  • Local Institution - 0048

    Sapporo, Hokkaido, 0608648

  • Local Institution - 0113

    Sasebo, Nagasaki, 8571195

  • Local Institution - 0021

    Sendai, Miyagi, 980-8574

  • Local Institution - 0171

    Shimotsuga, Tochigi, 321-0293

  • Local Institution - 0064

    Shinjyuku-ku, Tokyo, 162-8655

  • Local Institution - 0054

    Tokyo, 104-8560

  • Local Institution - 0051

    Tokyo, 1608582

  • Local Institution - 0083

    Toyoake, Aichi-ken, 470-1192

  • Local Institution - 0226

    Toyoma, Toyama, 930-0194

  • Local Institution - 0148

    Wakayama, 641-8510

  • Local Institution - 0157

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

Poland12 sites

  • Local Institution - 0224

    Chorzów, Silesian Voivodeship, 41-500

  • Local Institution - 0016

    Elblag, Warmian-Masurian Voivodeship, 82-300

  • Local Institution - 0029

    Krakow, Lesser Poland Voivodeship, 30-727

  • Local Institution - 0187

    Lodz, Łódź Voivodeship, 90-368

  • Local Institution - 0186

    Lublin, Lublin Voivodeship, 20-607

  • Local Institution - 0017

    Poznan, Greater Poland Voivodeship, 61-545

  • Local Institution - 0071

    Szczecin, 71-252

  • Local Institution - 0219

    Warsaw, Masovian Voivodeship, 02-665

  • Local Institution - 0185

    Warsaw, Masovian Voivodeship, 02-672

  • Local Institution - 0119

    Warsaw, Masovian Voivodeship, 03-291

  • Local Institution - 0014

    Warsaw, 00-874

  • Local Institution - 0031

    Wroclaw, 52-416

Other trials in Poland

Brazil11 sites

  • Local Institution - 0175

    Barretos, São Paulo, 14784400

  • Local Institution - 0028

    Lajeado, Rio Grande do Sul, 95900-000

  • Local Institution - 0154

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Local Institution - 0023

    Porto Alegre, Rio Grande do Sul, 90560032

  • Local Institution - 0230

    Porto Velho, Rondônia, 76801-098

  • Local Institution - 0087

    Rio de Janeiro, 22061-080

  • Local Institution - 0115

    São Bernardo do Campo, São Paulo, 09715-090

  • Local Institution - 0161

    São Paulo, 01327-001

  • Local Institution - 0062

    São Paulo, 01409-901

  • Local Institution - 0190

    São Paulo, 04266-010

  • Local Institution - 0160

    Vitória, Espírito Santo, 29055450

Other trials in Brazil

Mexico10 sites

  • Local Institution - 0106

    Chihuahua City, 31350

  • Local Institution - 0010

    Cuernavaca, Morelos, 62290

  • Local Institution - 0077

    Guadajalara, Jalisco, 44600

  • Local Institution - 0009

    León, Guanajuato, 37160

  • Local Institution - 0024

    Mexico City, Mexico City, 03100

  • Local Institution - 0011

    Mexico City, Mexico City, 06760

  • Local Institution - 0124

    Monterrey, Nuevo León, 64020

  • Local Institution - 0074

    Oaxaca City, 68000

  • Local Institution - 0107

    Torreón, Coahuila, 27000

  • Local Institution - 0026

    Zapopan, Jalisco, 45070

Other trials in Mexico

Argentina9 sites

  • Local Institution - 0146

    Ciudad de Buenos Aires, Buenos Aires, 1180

  • Local Institution - 0088

    La Plata, Buenos Aires, 1900

  • Local Institution - 0078

    Pergamino, Buenos Aires, B2700

  • Local Institution - 0125

    Pilar, Buenos Aires, 1629

  • Local Institution - 0018

    Quilmes, Buenos Aires F.D., 1879

  • Local Institution - 0020

    San Juan Bautista, Buenos Aires, 1888

  • Local Institution - 0013

    SAN M. de Tucuman, Tucumán Province, T4000AXL

  • Local Institution - 0136

    San Miguel, Buenos Aires, 1663

  • Local Institution - 0027

    San Miguel de Tucumán, Tucumán Province, T4000

Other trials in Argentina

India8 sites

  • Local Institution - 0234

    Ahmedabad, Gujarat, 380013

  • Local Institution - 0233

    Ahmedabad, Gujarat, 382443

  • Local Institution - 0191

    Hubli, Karnataka, 580021

  • Local Institution - 0235

    Hyderabad, Telangana, 500016

  • Local Institution - 0222

    Mysore, Karnataka, 570004

  • Local Institution - 0229

    Nagpur, Maharashtra, 440012

  • Local Institution - 0199

    Secundarabad, Telangana, 500003

  • Local Institution - 0210

    Vellore, Tamil Nadu, 632 004

Other trials in India

Spain8 sites

  • Local Institution - 0038

    Barcelona, Barcelona [Barcelona], 08035

  • Local Institution - 0110

    Bilbao, Basque Country, 48013

  • Local Institution - 0103

    Cordoba, Madrid, 14004

  • Local Institution - 0151

    Mérida, Badajoz, 06800

  • Local Institution - 0061

    Santander, Cantabria, 39008

  • Local Institution - 0052

    Seville, 41010

  • Local Institution - 0058

    Valencia, 46026

  • Local Institution - 0067

    Valladolid, 47012

Other trials in Spain

Chile7 sites

  • Local Institution - 0139

    La Serena, Coquimbo Region, 1720430

  • Local Institution - 0220

    Santiago, Santiago Metropolitan, 7500571

  • Local Institution - 0101

    Santiago, Santiago Metropolitan, 7500710

  • Local Institution - 0183

    Santiago, Santiago Metropolitan, 7501126

  • Local Institution - 0140

    Santiago, Santiago Metropolitan, 8330032

  • Local Institution - 0203

    Santiago, Santiago Metropolitan, 8380465

  • Local Institution - 0153

    Santiago, 7550000

Other trials in Chile

Taiwan7 sites

  • Local Institution - 0094

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301

  • Local Institution - 0040

    Taichung, Taichung, 402

  • Local Institution - 0065

    Taichung, 404332

  • Local Institution - 0114

    Taichung, 407

  • Local Institution - 0039

    Tainan, 71004

  • Local Institution - 0181

    Taipei, 10002

  • Local Institution - 0122

    Taipei, 11217

Other trials in Taiwan

Australia5 sites

  • Local Institution - 0177

    Ivanhoe, Victoria, 3079

  • Local Institution - 0179

    Liverpool, New South Wales, 2170

  • Local Institution - 0066

    Maroochydore, Queensland, 4558

  • Local Institution - 0182

    Parramatta, New South Wales, 2150

  • Local Institution - 0129

    Victoria Park, Western Australia, 6100

Other trials in Australia

United Kingdom5 sites

  • Local Institution - 0168

    Central Middlesbrough, Middlesbrough, TS4 3BW

  • Local Institution - 0223

    London, England, NW32QG

  • Local Institution - 0090

    London, Greater London, SE5 9RS

  • Local Institution - 0091

    London, London, City of, SE1 9RT

  • Local Institution - 0130

    Oxford, OX3 7LD

Other trials in United Kingdom

Hungary4 sites

  • Local Institution - 0035

    Gyula, Bekes County, 5700

  • Local Institution - 0057

    Pécs, Baranya, 7632

  • Local Institution - 0134

    Szeged, Csongrád megye, 6725

  • Local Institution - 0034

    Veszprém, Veszprém City, 8200

Other trials in Hungary

Peru4 sites

  • Local Institution - 0208

    Lima, 15046

  • Local Institution - 0176

    Lima, 15072

  • Local Institution - 0118

    Lima, 15419

  • Local Institution - 0121

    Lima, LIMA 31

Other trials in Peru

Portugal4 sites

  • Local Institution - 0105

    Lisbon, Lisbon District, 1649-035

  • Local Institution - 0144

    Lisbon, 1050-034

  • Local Institution - 0073

    Lisbon, 2720-276

  • Local Institution - 0109

    Vila Nova de Gaia, Porto District, 4434-502

Other trials in Portugal

Bulgaria3 sites

  • Local Institution - 0158

    Plovdiv, 4001

  • Local Institution - 0159

    Rousse, 7002

  • Local Institution - 0163

    Sofia, Sofia (stolitsa), 1463

Other trials in Bulgaria

Greece3 sites

  • Local Institution - 0123

    Athens, Attikí (Region), 115 27

  • Local Institution - 0116

    Athens, Attikí, 11527

  • Local Institution - 0138

    Larissa, Thessalía, 411 10

Other trials in Greece

Turkey (Türkiye)3 sites

  • Local Institution - 0184

    Ankara, 06230

  • Local Institution - 0166

    Antalya, 07059

  • Local Institution - 0188

    Gaziantep, 27090

Other trials in Turkey (Türkiye)

Czechia2 sites

  • Local Institution - 0174

    Ostrava, Ostrava Město, 70300

  • Local Institution - 0036

    Prague, 12850

Other trials in Czechia

Puerto Rico2 sites

  • Local Institution - 0240

    Caguas, 00725

  • Local Institution - 0194

    San Juan, 00909

Other trials in Puerto Rico

Singapore2 sites

  • Local Institution - 0135

    Singapore, 169608

  • Local Institution - 0127

    Singapore, 529889

Other trials in Singapore

Thailand2 sites

  • Local Institution - 0212

    Bangkok, Bangkok, 10400

  • Local Institution - 0211

    Bangkok, Bangkok, 10700

Other trials in Thailand

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-2)

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 NCT05620407
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 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

  6. 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

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

    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 posted17 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
513 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05620407
Sponsor's protocol ID
IM011-247
Other IDs
2022-500700-22
Acronym
POETYK SLE-2
Status last verified
Nov 2025
First submitted
10 Nov 2022
Last updated
2 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 180 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 9 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 2 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 180 sites in United States, Japan, Poland, Brazil, Mexico 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 NCT05620407, 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 2 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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