Clinical Trials

Interventional Drug Clinical Trials

Please click on table and use scroll bars at bottom and right side of table to navigate . Last updated on: 12 Jan 2025 This list contains only interventional drug trials, for all other type of studies, please refer to clinicaltrials.gov
Type of drugName of drug (Study Name)SponsorPatients who may be eligiblePhaseEnrollment (estimated)Route of administration of study drugLocation of trial sitesTrial identifier ( Click for more information on clinicaltrials.govEmail contact addressStudy WebsiteStudy Start (Estimated)Primary Completion (Estimated)Study Completion (Estimated)Primary EndpointKey Secondaries
1Humanized IgG1 mAb targeting KLRG1+ Tcell Ulviprubart ABC008AbcuroAdults with IBM (NO LONGER RECRUITING) 2/3231SC every 8 weeksINTERNATIONALNCT05721573IBM-201_clinicaltrial@abcuro.com 28/2/20231/11/20251/12/2025
2Humanized IgG1 mAb targeting KLRG1+ Tcell Ulviprubart ABC008AbcuroAdults with IBM ( Long term extension study; Active no longer recruiting )3270SC every 8 weeksUSA, AUSTRALIANCT06450886IBM-202_clinicaltrial@abcuro.com21/10/20241/1/20291/4/2029
3mTOR inhibitorSirolimusUniversity of Kansas Medical Center, USAAdults with IBM3140Oral,once dailyUSA, AUSTRALIANCT04789070aheim2@kumc.edu1/7/20221/9/20261/9/2026
4Subcutaneous Immunoglobulin (SCIg)IgPro20 Hizentra® (RECLAIIM)CSL BehringAdults with DM (NO LONGER RECRUITING )3126SC infusion weeklyINTERNATIONALNCT04044690clinicaltrials@cslbehring.com 21/10/201922/5/202822/5/2028
5Anti-ILT7HZN-7734 DaxdilimabAmgenAdults with DM and ASyS (NO LONGER RECRUITING )2SC injection weeklyUSA, AUSTRALIANCT05669014clinicaltrials@horizontherapeutics.com 4/12/202312/3/20252/10/2025
6TYK2 /JAK1 inhibitorBrepocitinib (VALOR)PriovantAdults with DM (NO LONGER RECRUITING )3241Oral,once dailyINTERNATIONALNCT05437263ValorStudyManager@PriovantTx.com https://valorstudy.com/31/10/20221/12/20241/12/2024
7TYK2 /JAK1 inhibitorBrepocitinib PriovantAdults with CADM ( Not yet recruiting )25Oral,once dailyNot availableNCT06433999lindsey.rios@priovanttx.com
matt.cascino@priovanttx.com
1/8/20241/12/20241/1/2025
8TYK2 inhibitorGLPG3667 (GALARISSO)Galapagos NVAdults with DM262Oral,once dailyINTERNATIONALNCT05695950medicalinfo@glpg.com https://www.glpg.com/innovation/clinical-trials/galarisso/27/2/20231/3/20251/3/2025
9TYK inhibitorNintedanib (MINT)Boehringer Ingelheim Myositis Associated Interstitial Lund Disease (MA-ILD)4134Oral,twice dailyUSANCT05799755wes48@pitt.edu https://mint.pitt.edu/1/8/20231/1/20251/6/2025
10TLR7/8 inhibitorEmpatoran M5049 (NEPTUNIA)EMD SeronoAdults with DM and PM240Oral,twice dailyINTERNATIONALNCT05650567service@emdgroup.com; eMediUSA@emdserono.com (US only )https://clinicaltrials.merckgroup.com/en/trial-details/?id=MS200569_004119/1/202316/7/20244/12/2024
11JAK 1/2 inhibitorBaricitinib (MYOCIT)Assistance Publique - Hôpitaux de ParisChildren 3-18 years old with new onset JDM216Oral,once dailyFRANCENCT05524311brigitte.bader-meunier@aphp.fr
laure.choupeaux@aphp.fr
10/11/20221/5/20261/9/2026
12JAK 1/2 inhibitorBaricitinib (BIRD)Assistance Publique - Hôpitaux de ParisAdults with DM362Oral,once dailyFRANCENCT04972760yves.allenbach@aphp.fr
sarra.pochon@aphp.fr
31/8/202228/2/202628/2/2026
13JAK 1 inhibitorFilgotinibUMC UtrechtAdults with DM260 ( IIM, Behcet's IgG4RD)Oral,once dailyNETHERLANDSNCT06285539a.c.a.marijnissen@umcutrecht.nl12/3/20241/12/20261/12/2026
14FcRn inhibitorEfgartigimod PH20 SC (ALKIVIA)ArgenxAdults with IIM (including DM, IMNM, PM, Asys)2/3240SC injection weeklyINTERNATIONALNCT05523167 ClinicalTrials@argenx.com https://myositis-study.com/12/10/20221/12/20261/2/2027
15FcRn inhibitorNipocalimab (SPIREA)JanssenAdults with IIM (including DM, IMNM, PM, Asys) (NO LONGER RECRUITING )236IV biweeklyINTERNATIONALNCT05379634Participate-In-This-Study@its.jnj.comhttps://globaltrialfinder.janssen.com/trial/cr1092105/7/202227/10/202514/9/2026
16C1s inhibitorRAY-121 (RAINBOW)Chugai; RocheAdults with DM and IMNM1144(DM, IMNM, ITP, APS, Behcet's, Bullous Pemphigoid, 1 IV infusion ; 2 SC injectionsINTERNATIONALNCT06371417clinical-trials@chugai-pharm.co.jp10/6/202430/6/202630/6/2026
17C2 inhibitorEmpasiprubart ARGX-117 (EMPACIFIC)ArgenxAdults with DM242IVUSA NCT06284954clinicaltrials@argenx.com20/8/202418/7/202520/1/2028
18C5 inhibitorPozelimab/CemdisiranAustin Neuromuscular CenterAdults with IBM110SC injection monthlyUSA NCT06479863yessar@austinneuromuscle.com
emil@austinneuromuscle.com
8/8/202430/5/202730/8/2027
19Type 1 IFN alpha and beta blockerAnifrolumab (JASMINE)AstraZenecaAdults with DM and PM3240INTERNATIONALNCT06455449information.center@astrazeneca.comhttps://www.astrazenecaclinicaltrials.com/study/D3463C00003/20/6/202414/5/20274/8/2028
20IFN beta blockerDazukibart PF-06823859PfizerAdults with DM and PM3270IV every 4 weeksINTERNATIONALNCT05895786ClinicalTrials.gov_Inquiries@pfizer.com 20/5/202323/7/202623/7/2026
21Bispecific antibody targeting myeloid cellsDR-0201Dren BioAdults with DM and PM ( Not yet recruiting )136 (SLE, CLE, pSS, PM/DM, dcSSc)IVINTERNATIONALNCT06647069clinops@drenbio.com1/11/20241/11/20261/11/2026
22GLP-1 receptor agonistPF1801 Froniglutide (FROG)ImmunoforgeAdults with DM and PM239SC injection weeklyKOREANCT05833711mini@immunoforge.com5/9/20231/3/20251/9/2025
23Cell Therapy Cell Therapy ADSVFAssistance Publique - Hôpitaux de ParisAdults with IBM132Injection of autologous uncultured adipose-derived stromal vascular fraction (ADSVF)FRANCENCT05032131olivier.benveniste@aphp.fr 1/2/20231/10/20231/4/2024
24CD19 CAR-T AutologousCABA-201 (RESET-Myositis)Cabaletta BioChildren 6 years to Adults 75 yrs old with refractory DM, ASyS, IMNM1/218infusion of CAR-T following preconditioning with fludarabine and cyclophosphamideUSA NCT06154252clinicaltrials@cabalettabio.com https://www.cabalettabio.com/patients/phase-12-trial-in-myositis20/12/20231/7/20281/7/2028
25CD19 CAR-T AutologousRapcabtagene Autoleucel NovartisAdults with myositis 2123Single IV infusion CAR-T or comparatorLocations TBCNCT06665256novartis.email@novartis.com30/10/20244/4/20294/4/2030
26CD19 CAR-T AutologousCC-97540Juno Therapeutics; BMSAdults with IIM (including DM, IMNM, PM, Asys)1129Infusions of CC-97540, Fludarabine, Cyclophosphamide, Tocilizumab as specifiedINTERNATIONALNCT05869955Clinical.Trials@bms.comhttps://www.bmsstudyconnect.com/es/en/clinical-trials/NCT05869955.html13/9/202315/11/202715/11/2027
27CD19 CAR-T AllogenicCNTY-101 (CALiPSO-1) +/-1 IL-2Century TherapeuticsAdults with DM, PM, ASyS148 ( SLE, LN, IIM, dcSSc )Lymphodepletion, IV infusion CAR-T, SC injection IL-2USANCT06255028calipso-1_clinicalteam@centurytx.com2/8/20241/8/20281/8/2028
28CD19 CAR-T AutologousKYV-101 (CARTIMMUNE)University of Pennsylvania ; KyvernaAdults with IIM (including DM, IMNM, PM )124( PM, DM, IMNM, dcSSc, SLE, AAV)infusion of CAR-T following preconditioning with fludarabine and cyclophosphamideUSANCT06152172Emily.Marcuson@Pennmedicine.upenn.edu
Jacqui.Rick@pennmedicine.upenn.edu
5/8/20241/8/20281/8/2028
29CD19 CAR-T AutologousKYV 101 Stanford UniversityAdults >25<72 yrs Refractory DM1b21infusion of CAR-T following preconditioning with fludarabine and cyclophosphamideUSANCT06298019fiorentino@stanford.edu1/4/20241/4/20271/4/2039
30CD7 CAR-T AllogenicCD7 CAR T-cellsZhejiang UniversityChild, Adult, Older adult with DM (UNKNOWN STATUS )175 (Crohn's, UC, DM, Still's ) Single IV infusion CAR-T or comparatorCHINANCT05239702huyongxian2000@aliyun.com
hehuangyu@126.com
28/2/20221/12/20241/12/2024
31CD19 CAR-T Autologousanti-CD19 CAR T cell therapy (CASTLE)University of Erlangen-Nürnberg Medical SchoolAdults with IIM & other autoimmune diseases1/224 (PM, DM, SLE, SScl)Single IV infusion CAR-T GermanyNCT06347718georg.schett@uk-erlangen.de; daniela.bohr@uk-erlangen.de17/7/202331/5/202631/5/2026
32CD19 CAR-T AutologousCT103A (CARTinNS)Tongji HospitalAdults with IIM & other autoimmune diseases136 (NMOSD, MG, CIDP, IIM, MS, AE, MOGAD, POEMS )infusion of CAR-T following preconditioning with fludarabine and cyclophosphamideCHINANCT04561557chuanqin@tjh.tjmu.edu.cn22/9/202022/2/202731/5/2027
33CD19 CAR-T AutologousCD19 CAR-T Chongqing Precision Biotech CoAdults with DM & other autoimmune diseases124(SLE, SS, SScl, DM, ANCA Vasculitis )Single IV infusion CAR-T CHINANCT060569211315710223@qq.com31/8/202331/12/202531/8/2025
34CD19 CAR-T AutologousRD06-04 Nanjing Bioheng Biotech Adults with IIM & other autoimmune diseases120(SLE, SSc, AAV, IIM, and pSS)Single IV infusion CAR-T CHINANCT06548607peng.yu@bioheng.com
ming.gao@bioheng.com
29/7/202429/7/202629/7/2027
35CD19 CAR-T AutologousCD19 CAR-T Chongqing Precision Biotech CoChildren with refractory JDM110Lymphodepletion, IV infusion CAR-TCHINANCT06569472meipinglu@zju.edu.cn2/7/202431/7/202731/7/2028
36CD19 CAR-T AllogenicAnti-CD19 UCAR-T cellsChongqing Precision Biotech CoChildren with refractory JDM118Lymphodepletion, IV infusion CAR-TCHINANCT06686524meipinglu@zju.edu.cn11/11/202410/11/202610/11/2027
37CD19 CAR-T AllogenicUTAA09 PersonGen BioTherapeutics (Suzhou)Adults with IIM & other autoimmune diseases ( not yet recruiting110 ( IIM, SLE, SS, SScl, RA, ITP, PBC)Single IV infusion CAR-T CHINANCT06417398njwujian@163.com14/5/20241/12/20241/5/2025
38CD19 CAR-T AllogenicRD06-04 Nanjing Bioheng Biotech Adults with IIM & other autoimmune diseases112(SLE, SSc, AAV, IIM, and pSS)Single IV infusion CAR-T CHINANCT06549296peng.yu@bioheng.com
ming.gao@bioheng.com
31/8/20241/8/20261/8/2027
39CD19 CAR-T AllogenicCD19-CAR-DNT (RJMty19)  RenJi HospitalAdults with IIM & other autoimmune diseases148(SLE, SSc IIM, and ANCA Vas)Single IV infusion CAR-T CHINANCT06285539fuqiong@renji.com30/10/20231/6/20241/6/2026
40CD19 CAR-T AllogenicBRL-301Bioray LaboratoriesAdults with IIM & other autoimmune diseases (by invitation only)N/A15(SLE, SS, SSc, IIM, ANCA Vasculitis, Antiphospholipid syndrome )Single IV infusion CAR-T CHINANCT05859997N/A5/17/20235/27/20245/27/2025
41Anti-CD19 CAR-NK Allogenicn/aZhejiang UniversityAdults with IIM & other autoimmune diseases ( not yet recruiting)115( SS, SSc, IIM, ANCA Vasculitis, Antiphospholipid syndrome )Lymphodepletion then dose-escalated 3 IV infusions CAR-NK CHINANCT06614270jingxue@zju.edu.cn11/20/202411/1/202511/1/2027
42Anti-CD19 CAR-NK allogenicNKX019 /Cyclophosphamide (Ntrust)Nkarta, Inc.Adults with IIM & other autoimmune diseases190 ( SSc, IIM, ANCA-AAVLymphodepletion then dose-escalation 3 infusions CAR-NK USNCT06733935medmonitor@nkartatx.com11/4/202410.202810.2028
Abbreviations

AAV: Anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis

ASyS: Anti-Synthetase Syndrome

CLE: Cutaneous Lupus Erythematosus

dcSSC: diffuse cutaneous Systemic Sclerosis

DM: Dermatomyositis
JDM: Juvenile Dermatomyositis

FcRn: Neonatal fragment crystallizable receptor

GLP: Glucagon like peptide

JAK: Janus Kinase

KLRG1: Killer cell lectin-like receptor G1

IBM: Inclusion Body Myositis

IFN: Interferon

IIM: Idiopathic Inflammatory Myopathies

ILT: Immunoglobulin like transcript
IMNM: Immune-mediated Necrotising Myopathy
LN: Lupus Nephritis

mAb: monoclonal antibody

MA-ILD: Myositis Associated Interstitial Lung Disease

mTOR: mammalian Target of Rapamycin

PM: Polymyositis

SC: Subcutaneous

SLE: Systemic Lupus Erythematosus

TLR: Toll like receptor

TYK: Tyrosine Kinase

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