Systemic Lupus Erythematosus

Immunology
80
Pipeline Programs
30
Companies
50
Clinical Trials
10 recruiting
4
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
28
4
26
0
16
6
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
1464%
Cell Therapy
418%
Small Molecule
314%
Peptide
15%
+ 56 programs with unclassified modality

On Market (4)

Approved therapies currently available

GSK
BENLYSTAApproved
belimumab
GSK
B Lymphocyte Stimulator-specific Inhibitor [EPC]injection2011
AbbVie
RINVOQApproved
upadacitinib
AbbVie
Janus Kinase Inhibitor [EPC]oral2019
AbbVie
RINVOQ LQApproved
upadacitinib
AbbVie
Janus Kinase Inhibitor [EPC]oral2024
Bristol Myers Squibb
SOTYKTUApproved
deucravacitinib
Bristol Myers Squibb
Tyrosine Kinase 2 Inhibitor [EPC]oral2022

Competitive Landscape

38 companies ranked by most advanced pipeline stage

GSK
GSKLONDON, United Kingdom
5 programs
2
2
1
Belimumab plus Early VaccinationPhase 41 trial
Belimumab 1 mg/kgPhase 31 trial
belimumabPhase 3Monoclonal Antibody1 trial
BENLYSTA(Belimumab)Phase 2Monoclonal Antibody1 trial
belimumab 10mg/kgPhase 21 trial
Active Trials
NCT00583362Completed298Est. Feb 2016
NCT01649765Completed93Est. Sep 2025
NCT00724867Completed268Est. Mar 2015
+2 more trials
Bristol Myers Squibb
3 programs
2
1
1
DeucravacitinibPhase 3Small Molecule5 trials
AfimetoranPhase 22 trials
BMS-986165Phase 21 trial
Active Trials
NCT05901714Completed65Est. Apr 2024
NCT04895696Active Not Recruiting268Est. Apr 2029
NCT03920267Completed261Est. Mar 2025
+5 more trials
AbbVie
AbbVieNORTH CHICAGO, IL
1 program
1
1
UpadacitinibPhase 3Small Molecule1 trial
Active Trials
NCT05843643Recruiting1,000Est. Oct 2027
Alliance Pharmaceuticals
1 program
1
AtorvastatinPhase 4Small Molecule1 trial
Active Trials
NCT00120887Completed200Est. Dec 2005
UP
13 programs
1
4
8
DZPPhase 31 trial
DZPPhase 31 trial
Dapirolizumab pegolPhase 31 trial
EpratuzumabPhase 3Monoclonal Antibody1 trial
EpratuzumabPhase 3Monoclonal Antibody1 trial
+8 more programs
Active Trials
NCT02306629Completed42Est. Apr 2015
NCT01534403Completed17Est. Feb 2015
NCT00660881Completed210Est. Dec 2011
+10 more trials
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
5 programs
1
3
1
AnifrolumabPhase 3Monoclonal Antibody1 trial
ICI 182,780Phase 21 trial
MEDI-545Phase 21 trial
MEDI-546Phase 21 trial
AZD5492Phase 11 trial
Active Trials
NCT06916806Recruiting72Est. Jun 2027
NCT00417430Completed20Est. Dec 2006
NCT01031836Completed30Est. Jul 2016
+2 more trials
Teva
TevaIsrael - Petach Tikva
3 programs
2
1
CEP-33457Phase 31 trial
CEP-33457Phase 21 trial
edratidePhase 2Peptide1 trial
Active Trials
NCT01135459Completed183Est. Jun 2012
NCT00203151Terminated340Est. Feb 2007
NCT01240694Terminated136Est. Jun 2012
Vor Biopharma
2 programs
2
TelitaciceptPhase 31 trial
TelitaciceptPhase 31 trial
Active Trials
NCT05306574Terminated91Est. Jan 2025
NCT06456567Withdrawn0Est. Jan 2025
Amgen
6 programs
5
1
DaxdilimabPhase 2Monoclonal Antibody1 trial
AMG 557Phase 12 trials
AMG 570Phase 11 trial
AMG 623Phase 11 trial
AMG 811Phase 12 trials
+1 more programs
Active Trials
NCT00774943Completed58Est. May 2012
NCT02391259Completed57Est. Nov 2011
NCT02618967Completed56Est. Dec 2018
+7 more trials
Galapagos
Galapagos2800 MECHELEN, Belgium
2 programs
1
1
GLPG3667Phase 21 trial
GLPG3970 film-coated tabletPhase 11 trial
Active Trials
NCT04700267Terminated11Est. Oct 2021
NCT05856448Active Not Recruiting186Est. Mar 2026
Nektar Therapeutics
Nektar TherapeuticsSAN FRANCISCO, CA
2 programs
1
1
LY3471851Phase 2
LY3471851Phase 1
CT
1
1
TQB3702 TabletsPhase 21 trial
TQB3702 tabletsPhase 11 trial
Active Trials
NCT06448273RecruitingEst. Oct 2024
NCT06859931Not Yet RecruitingEst. Dec 2026
VP
1 program
1
ALPN-101Phase 21 trial
Active Trials
NCT04835441CompletedEst. Jul 2024
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
1 program
1
BI 3000202Phase 21 trial
Active Trials
NCT07409181Not Yet Recruiting405Est. Jun 2029
Biotest Pharmaceuticals
1
BT063Phase 21 trial
Active Trials
NCT02554019CompletedEst. Oct 2017
Rigel Pharmaceuticals
Rigel PharmaceuticalsSOUTH SAN FRANCISCO, CA
1 program
1
Fostamatinib DisodiumPhase 21 trial
Active Trials
NCT00752999WithdrawnEst. Mar 2010
Corbus Pharmaceuticals
1 program
1
JBT-101Phase 21 trial
Active Trials
NCT03093402Completed109Est. Jul 2021
Allergy Therapeutics
1
LeukapheresisPhase 21 trial
Active Trials
NCT00230035Withdrawn
Zenas BioPharma
Zenas BioPharmaWALTHAM, MA
1 program
1
ObexelimabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT06559163Recruiting190Est. Sep 2026
Xencor
XencorPASADENA, CA
1 program
1
XmAb5871Phase 21 trial
Active Trials
NCT02725515CompletedEst. Jul 2018
AB
Active BiotechSweden - Lund
1 program
1
paquinimodPhase 21 trial
Active Trials
NCT00997100CompletedEst. Sep 2010
Pfizer
PfizerNEW YORK, NY
3 programs
1
1
Arthritis Self Management ProgramPhase 1/21 trial
TRU-015Phase 11 trial
Web-based Genetic Research on LupusN/A1 trial
Active Trials
NCT02530944Completed5,000Est. Oct 2017
NCT00479622Terminated20Est. May 2008
NCT01351662Completed30Est. Oct 2011
InnoCare
InnoCareChina - Beijing
2 programs
1
1
ICP-022Phase 1/21 trial
ICP-022Phase 11 trial
Active Trials
NCT03189017Completed64Est. Oct 2018
NCT04305197Completed60Est. Apr 2022
Cabaletta Bio
Cabaletta BioPHILADELPHIA, PA
1 program
1
CABA-201Phase 1/21 trial
Active Trials
NCT06121297Recruiting28Est. Dec 2029
Novartis
NovartisBASEL, Switzerland
1 program
1
YTB323Phase 1/22 trials
Active Trials
NCT06704269Recruiting15Est. Oct 2029
NCT05798117Active Not Recruiting21Est. Sep 2026
Precision BioSciences
4 programs
4
BCMA/CD70 CAR-T cellsPhase 1Cell Therapy1 trial
CD19 CAR-T cellsPhase 1Cell Therapy1 trial
PTOC1Phase 11 trial
anti-CD19-CAR-T cellsPhase 1Cell Therapy1 trial
Active Trials
NCT07318259Recruiting18Est. Aug 2028
NCT07331467Recruiting18Est. Aug 2028
NCT07403097Recruiting18Est. Dec 2028
+1 more trials
M&
Merck & Co.RAHWAY, NJ
2 programs
2
GardasilPhase 15 trials
MK-1045Phase 11 trial
Active Trials
NCT07224477Not Yet Recruiting525Est. Apr 2028
NCT06688058Active Not Recruiting72Est. Nov 2026
NCT06623409Active Not Recruiting72Est. Nov 2026
+3 more trials
Takeda
TakedaTOKYO, Japan
1 program
1
Anti-Macrophage Migration Inhibitory FactorPhase 12 trials
Active Trials
NCT01765790Completed68Est. Jul 2016
NCT01541670Terminated4Est. Dec 2012
Biogen
1 program
1
BIIB059Phase 11 trial
Active Trials
NCT02106897Completed109Est. May 2016
Climb Bio
Climb BioMA - Wellesley Hills
1 program
1
BudoprutugPhase 11 trial
Active Trials
NCT07011043RecruitingEst. Apr 2027

+8 more companies

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Bristol Myers SquibbDeucravacitinib
Merck & Co.Gardasil
Bristol Myers SquibbDeucravacitinib
Bristol Myers SquibbDeucravacitinib
Bristol Myers SquibbDeucravacitinib
Merck & Co.Gardasil
Merck & Co.Gardasil
Merck & Co.Gardasil
Merck & Co.Gardasil
GSKBelimumab plus Early Vaccination
Merck & Co.Gardasil
Alliance PharmaceuticalsAtorvastatin
Bristol Myers SquibbDeucravacitinib
Bristol Myers SquibbDeucravacitinib
Bristol Myers SquibbDeucravacitinib

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 127,745 patients across 50 trials

A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132

Start: Feb 2026Est. completion: Dec 202635 patients
Phase 4Recruiting

Faster Elimination of HPV Infection and Cervical Cancer Using Concomitant HPV Vaccination and HPV Screening: A Demonstration Project in Rwanda

Start: Sep 2024Est. completion: Mar 2026100,000 patients
Phase 4Not Yet Recruiting

A Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants

Start: Jun 2024Est. completion: Nov 20248 patients
Phase 4Completed

A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis

Start: Oct 2023Est. completion: Apr 2025130 patients
Phase 4Terminated

Correction of Psoriatic T Cell Signatures by Deucravacitinib

Start: Oct 2023Est. completion: Jun 202625 patients
Phase 4Recruiting

HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini

Start: Apr 2022Est. completion: Dec 20241,403 patients
Phase 4Completed

An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen

Start: Dec 2020Est. completion: Jun 2026352 patients
Phase 4Active Not Recruiting

HPV Vaccination Study in Postpartum Women

Start: Aug 2020Est. completion: Feb 2023225 patients
Phase 4Completed

Postpartum HPV Vaccination

Start: Apr 2019Est. completion: Dec 2020195 patients
Phase 4Completed
NCT01597492GSKBelimumab plus Early Vaccination

A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)

Start: May 2012Est. completion: Sep 201579 patients
Phase 4Completed

Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers

Start: Oct 2009Est. completion: Aug 2011200 patients
Phase 4Completed

Lupus Atherosclerosis Prevention Study

Start: Apr 2002Est. completion: Dec 2005200 patients
Phase 4Completed

A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis

Start: Dec 2025Est. completion: Aug 2034366 patients
Phase 3Recruiting

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

Start: Sep 2025Est. completion: Jan 20313,040 patients
Phase 3Recruiting

A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis

Start: Mar 2025Est. completion: Mar 203160 patients
Phase 3Recruiting

A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

Start: Nov 2024Est. completion: May 2028450 patients
Phase 3Recruiting

A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2)

Start: Sep 2024Est. completion: Jan 20250
Phase 3Withdrawn

An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants

Start: Mar 2024Est. completion: Jan 2030100 patients
Phase 3Recruiting

A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

Start: Sep 2023Est. completion: Nov 2028774 patients
Phase 3Active Not Recruiting
NCT05843643AbbVieUpadacitinib

Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus

Start: Jul 2023Est. completion: Oct 20271,000 patients
Phase 3Recruiting

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

Start: Jan 2023Est. completion: Nov 2028513 patients
Phase 3Active Not Recruiting

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

Start: Jan 2023Est. completion: Nov 2028516 patients
Phase 3Active Not Recruiting

A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)

Start: Jun 2022Est. completion: Jan 202591 patients
Phase 3Terminated
NCT04976322UCB PharmaDapirolizumab pegol

A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus

Start: Jul 2021Est. completion: Aug 2030760 patients
Phase 3Enrolling By Invitation

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

Start: Jul 2021Est. completion: Nov 2026729 patients
Phase 3Active Not Recruiting

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

Start: Jul 2021Est. completion: Jun 2027670 patients
Phase 3Active Not Recruiting

A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis

Start: Mar 2021Est. completion: Sep 2033153 patients
Phase 3Recruiting

A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

Start: Aug 2020Est. completion: Jun 2024321 patients
Phase 3Completed

Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis

Start: Aug 2019Est. completion: Jul 20261,466 patients
Phase 3Active Not Recruiting

Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus

Start: Jul 2011Est. completion: Feb 20161,250 patients
Phase 3Completed

A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Participants With Systemic Lupus Erythematosus

Start: Dec 2010Est. completion: Jun 2012136 patients
Phase 3Terminated

Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus

Start: Dec 2010Est. completion: May 2015793 patients
Phase 3Completed

Tolerability and Immunogenicity of Gardasil in Females Between 16 and 23 Years of Age in India (V501-034)

Start: Oct 2009Est. completion: Oct 20130
Phase 3Withdrawn
NCT00724867GSKBelimumab 1 mg/kg

A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States

Start: Aug 2008Est. completion: Mar 2015268 patients
Phase 3Completed

A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057

Start: May 2008Est. completion: Dec 2016738 patients
Phase 3Completed

Study of Epratuzumab in Systemic Lupus Erythematosus

Start: Jan 20070
Phase 3Withdrawn

Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)

Start: May 2006Est. completion: May 2007843 patients
Phase 3Completed

Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025)

Start: Apr 2006Est. completion: Apr 20071,042 patients
Phase 3Completed

Study of Epratuzumab in Systemic Lupus Erythematosus

Start: Jun 2005Est. completion: Mar 2007510 patients
Phase 3Terminated

Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

Start: May 2005Est. completion: Mar 200754 patients
Phase 3Terminated

Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)

Start: Dec 2002Est. completion: Feb 20093,055 patients
Phase 3Completed

Immunogenicity Bridge Between an Investigational Monovalent Vaccine and the Equivalent Component of Gardasil (V501) a Quadrivalent Vaccine (V501-012)(COMPLETED)

Start: Jun 2002Est. completion: Aug 20083,882 patients
Phase 3Completed

A Clinical Study of V540A in Healthy Female Participants (V540A-005)

Start: Jul 2026Est. completion: Apr 2028525 patients
Phase 2Not Yet Recruiting

A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)

Start: Apr 2026Est. completion: Jun 2029405 patients
Phase 2Not Yet Recruiting

Clinical Trial of TQB3702 Tablets in Subjects With Systemic Lupus Erythematosus (SLE)

Start: Mar 2025Est. completion: Dec 2026
Phase 2Not Yet Recruiting

Tyrosine Kinase 2 (TYK2) for GA and CS

Start: Mar 2025Est. completion: Jun 20260
Phase 2Withdrawn

Deucravacitinib Rosacea

Start: Nov 2024Est. completion: Jan 20260
Phase 2Withdrawn

A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

Start: Sep 2024Est. completion: Sep 2026190 patients
Phase 2Recruiting

Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo Hidradenitis Suppurativa (HS).

Start: Nov 2023Est. completion: Apr 20257 patients
Phase 2Terminated

A Study Evaluating the Effects of GLPG3667 Administered as Oral Treatment in Adult Participants With Active Systemic Lupus Erythematosus

Start: Jun 2023Est. completion: Mar 2026186 patients
Phase 2Active Not Recruiting

Related Jobs in Immunology

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

16 late-stage (Phase 3) programs — potential near-term approvals
10 actively recruiting trials targeting 127,745 patients
30 companies competing in this space