Clinical Trials
Interventional Drug Clinical Trials
Type of drug | Name of drug (Study Name) | Sponsor | Patients who may be eligible | Phase | Enrollment (estimated) | Route of administration of study drug | Location of trial sites | Trial identifier ( Click for more information on clinicaltrials.gov | Email contact address | Study Website | Study Start (Estimated) | Primary Completion (Estimated) | Study Completion (Estimated) | Primary Endpoint | Key Secondaries | |||||||||||
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1 | Humanized IgG1 mAb targeting KLRG1+ Tcell | Ulviprubart ABC008 | Abcuro | Adults with IBM (NO LONGER RECRUITING) | 2/3 | 231 | SC every 8 weeks | INTERNATIONAL | NCT05721573 | IBM-201_clinicaltrial@abcuro.com | 28/2/2023 | 1/11/2025 | 1/12/2025 | |||||||||||||
2 | Humanized IgG1 mAb targeting KLRG1+ Tcell | Ulviprubart ABC008 | Abcuro | Adults with IBM ( Long term extension study; Active no longer recruiting ) | 3 | 270 | SC every 8 weeks | USA, AUSTRALIA | NCT06450886 | IBM-202_clinicaltrial@abcuro.com | 21/10/2024 | 1/1/2029 | 1/4/2029 | |||||||||||||
3 | mTOR inhibitor | Sirolimus | University of Kansas Medical Center, USA | Adults with IBM | 3 | 140 | Oral,once daily | USA, AUSTRALIA | NCT04789070 | aheim2@kumc.edu | 1/7/2022 | 1/9/2026 | 1/9/2026 | |||||||||||||
4 | Subcutaneous Immunoglobulin (SCIg) | IgPro20 Hizentra® (RECLAIIM) | CSL Behring | Adults with DM (NO LONGER RECRUITING ) | 3 | 126 | SC infusion weekly | INTERNATIONAL | NCT04044690 | clinicaltrials@cslbehring.com | 21/10/2019 | 22/5/2028 | 22/5/2028 | |||||||||||||
5 | Anti-ILT7 | HZN-7734 Daxdilimab | Amgen | Adults with DM and ASyS (NO LONGER RECRUITING ) | 2 | SC injection weekly | USA, AUSTRALIA | NCT05669014 | clinicaltrials@horizontherapeutics.com | 4/12/2023 | 12/3/2025 | 2/10/2025 | ||||||||||||||
6 | TYK2 /JAK1 inhibitor | Brepocitinib (VALOR) | Priovant | Adults with DM (NO LONGER RECRUITING ) | 3 | 241 | Oral,once daily | INTERNATIONAL | NCT05437263 | ValorStudyManager@PriovantTx.com | https://valorstudy.com/ | 31/10/2022 | 1/12/2024 | 1/12/2024 | ||||||||||||
7 | TYK2 /JAK1 inhibitor | Brepocitinib | Priovant | Adults with CADM ( Not yet recruiting ) | 2 | 5 | Oral,once daily | Not available | NCT06433999 | lindsey.rios@priovanttx.com matt.cascino@priovanttx.com | 1/8/2024 | 1/12/2024 | 1/1/2025 | |||||||||||||
8 | TYK2 inhibitor | GLPG3667 (GALARISSO) | Galapagos NV | Adults with DM | 2 | 62 | Oral,once daily | INTERNATIONAL | NCT05695950 | medicalinfo@glpg.com | https://www.glpg.com/innovation/clinical-trials/galarisso/ | 27/2/2023 | 1/3/2025 | 1/3/2025 | ||||||||||||
9 | TYK inhibitor | Nintedanib (MINT) | Boehringer Ingelheim | Myositis Associated Interstitial Lund Disease (MA-ILD) | 4 | 134 | Oral,twice daily | USA | NCT05799755 | wes48@pitt.edu | https://mint.pitt.edu/ | 1/8/2023 | 1/1/2025 | 1/6/2025 | ||||||||||||
10 | TLR7/8 inhibitor | Empatoran M5049 (NEPTUNIA) | EMD Serono | Adults with DM and PM | 2 | 40 | Oral,twice daily | INTERNATIONAL | NCT05650567 | service@emdgroup.com; eMediUSA@emdserono.com (US only ) | https://clinicaltrials.merckgroup.com/en/trial-details/?id=MS200569_0041 | 19/1/2023 | 16/7/2024 | 4/12/2024 | ||||||||||||
11 | JAK 1/2 inhibitor | Baricitinib (MYOCIT) | Assistance Publique - Hôpitaux de Paris | Children 3-18 years old with new onset JDM | 2 | 16 | Oral,once daily | FRANCE | NCT05524311 | brigitte.bader-meunier@aphp.fr laure.choupeaux@aphp.fr | 10/11/2022 | 1/5/2026 | 1/9/2026 | |||||||||||||
12 | JAK 1/2 inhibitor | Baricitinib (BIRD) | Assistance Publique - Hôpitaux de Paris | Adults with DM | 3 | 62 | Oral,once daily | FRANCE | NCT04972760 | yves.allenbach@aphp.fr sarra.pochon@aphp.fr | 31/8/2022 | 28/2/2026 | 28/2/2026 | |||||||||||||
13 | JAK 1 inhibitor | Filgotinib | UMC Utrecht | Adults with DM | 2 | 60 ( IIM, Behcet's IgG4RD) | Oral,once daily | NETHERLANDS | NCT06285539 | a.c.a.marijnissen@umcutrecht.nl | 12/3/2024 | 1/12/2026 | 1/12/2026 | |||||||||||||
14 | FcRn inhibitor | Efgartigimod PH20 SC (ALKIVIA) | Argenx | Adults with IIM (including DM, IMNM, PM, Asys) | 2/3 | 240 | SC injection weekly | INTERNATIONAL | NCT05523167 | ClinicalTrials@argenx.com | https://myositis-study.com/ | 12/10/2022 | 1/12/2026 | 1/2/2027 | ||||||||||||
15 | FcRn inhibitor | Nipocalimab (SPIREA) | Janssen | Adults with IIM (including DM, IMNM, PM, Asys) (NO LONGER RECRUITING ) | 2 | 36 | IV biweekly | INTERNATIONAL | NCT05379634 | Participate-In-This-Study@its.jnj.com | https://globaltrialfinder.janssen.com/trial/cr109210 | 5/7/2022 | 27/10/2025 | 14/9/2026 | ||||||||||||
16 | C1s inhibitor | RAY-121 (RAINBOW) | Chugai; Roche | Adults with DM and IMNM | 1 | 144(DM, IMNM, ITP, APS, Behcet's, Bullous Pemphigoid, | 1 IV infusion ; 2 SC injections | INTERNATIONAL | NCT06371417 | clinical-trials@chugai-pharm.co.jp | 10/6/2024 | 30/6/2026 | 30/6/2026 | |||||||||||||
17 | C2 inhibitor | Empasiprubart ARGX-117 (EMPACIFIC) | Argenx | Adults with DM | 2 | 42 | IV | USA | NCT06284954 | clinicaltrials@argenx.com | 20/8/2024 | 18/7/2025 | 20/1/2028 | |||||||||||||
18 | C5 inhibitor | Pozelimab/Cemdisiran | Austin Neuromuscular Center | Adults with IBM | 1 | 10 | SC injection monthly | USA | NCT06479863 | yessar@austinneuromuscle.com emil@austinneuromuscle.com | 8/8/2024 | 30/5/2027 | 30/8/2027 | |||||||||||||
19 | Type 1 IFN alpha and beta blocker | Anifrolumab (JASMINE) | AstraZeneca | Adults with DM and PM | 3 | 240 | INTERNATIONAL | NCT06455449 | information.center@astrazeneca.com | https://www.astrazenecaclinicaltrials.com/study/D3463C00003/ | 20/6/2024 | 14/5/2027 | 4/8/2028 | |||||||||||||
20 | IFN beta blocker | Dazukibart PF-06823859 | Pfizer | Adults with DM and PM | 3 | 270 | IV every 4 weeks | INTERNATIONAL | NCT05895786 | ClinicalTrials.gov_Inquiries@pfizer.com | 20/5/2023 | 23/7/2026 | 23/7/2026 | |||||||||||||
21 | Bispecific antibody targeting myeloid cells | DR-0201 | Dren Bio | Adults with DM and PM ( Not yet recruiting ) | 1 | 36 (SLE, CLE, pSS, PM/DM, dcSSc) | IV | INTERNATIONAL | NCT06647069 | clinops@drenbio.com | 1/11/2024 | 1/11/2026 | 1/11/2026 | |||||||||||||
22 | GLP-1 receptor agonist | PF1801 Froniglutide (FROG) | Immunoforge | Adults with DM and PM | 2 | 39 | SC injection weekly | KOREA | NCT05833711 | mini@immunoforge.com | 5/9/2023 | 1/3/2025 | 1/9/2025 | |||||||||||||
23 | Cell Therapy | Cell Therapy ADSVF | Assistance Publique - Hôpitaux de Paris | Adults with IBM | 1 | 32 | Injection of autologous uncultured adipose-derived stromal vascular fraction (ADSVF) | FRANCE | NCT05032131 | olivier.benveniste@aphp.fr | 1/2/2023 | 1/10/2023 | 1/4/2024 | |||||||||||||
24 | CD19 CAR-T Autologous | CABA-201 (RESET-Myositis) | Cabaletta Bio | Children 6 years to Adults 75 yrs old with refractory DM, ASyS, IMNM | 1/2 | 18 | infusion of CAR-T following preconditioning with fludarabine and cyclophosphamide | USA | NCT06154252 | clinicaltrials@cabalettabio.com | https://www.cabalettabio.com/patients/phase-12-trial-in-myositis | 20/12/2023 | 1/7/2028 | 1/7/2028 | ||||||||||||
25 | CD19 CAR-T Autologous | Rapcabtagene Autoleucel | Novartis | Adults with myositis | 2 | 123 | Single IV infusion CAR-T or comparator | Locations TBC | NCT06665256 | novartis.email@novartis.com | 30/10/2024 | 4/4/2029 | 4/4/2030 | |||||||||||||
26 | CD19 CAR-T Autologous | CC-97540 | Juno Therapeutics; BMS | Adults with IIM (including DM, IMNM, PM, Asys) | 1 | 129 | Infusions of CC-97540, Fludarabine, Cyclophosphamide, Tocilizumab as specified | INTERNATIONAL | NCT05869955 | Clinical.Trials@bms.com | https://www.bmsstudyconnect.com/es/en/clinical-trials/NCT05869955.html | 13/9/2023 | 15/11/2027 | 15/11/2027 | ||||||||||||
27 | CD19 CAR-T Allogenic | CNTY-101 (CALiPSO-1) +/-1 IL-2 | Century Therapeutics | Adults with DM, PM, ASyS | 1 | 48 ( SLE, LN, IIM, dcSSc ) | Lymphodepletion, IV infusion CAR-T, SC injection IL-2 | USA | NCT06255028 | calipso-1_clinicalteam@centurytx.com | 2/8/2024 | 1/8/2028 | 1/8/2028 | |||||||||||||
28 | CD19 CAR-T Autologous | KYV-101 (CARTIMMUNE) | University of Pennsylvania ; Kyverna | Adults with IIM (including DM, IMNM, PM ) | 1 | 24( PM, DM, IMNM, dcSSc, SLE, AAV) | infusion of CAR-T following preconditioning with fludarabine and cyclophosphamide | USA | NCT06152172 | Emily.Marcuson@Pennmedicine.upenn.edu Jacqui.Rick@pennmedicine.upenn.edu | 5/8/2024 | 1/8/2028 | 1/8/2028 | |||||||||||||
29 | CD19 CAR-T Autologous | KYV 101 | Stanford University | Adults >25<72 yrs Refractory DM | 1b | 21 | infusion of CAR-T following preconditioning with fludarabine and cyclophosphamide | USA | NCT06298019 | fiorentino@stanford.edu | 1/4/2024 | 1/4/2027 | 1/4/2039 | |||||||||||||
30 | CD7 CAR-T Allogenic | CD7 CAR T-cells | Zhejiang University | Child, Adult, Older adult with DM (UNKNOWN STATUS ) | 1 | 75 (Crohn's, UC, DM, Still's ) | Single IV infusion CAR-T or comparator | CHINA | NCT05239702 | huyongxian2000@aliyun.com hehuangyu@126.com | 28/2/2022 | 1/12/2024 | 1/12/2024 | |||||||||||||
31 | CD19 CAR-T Autologous | anti-CD19 CAR T cell therapy (CASTLE) | University of Erlangen-Nürnberg Medical School | Adults with IIM & other autoimmune diseases | 1/2 | 24 (PM, DM, SLE, SScl) | Single IV infusion CAR-T | Germany | NCT06347718 | georg.schett@uk-erlangen.de; daniela.bohr@uk-erlangen.de | 17/7/2023 | 31/5/2026 | 31/5/2026 | |||||||||||||
32 | CD19 CAR-T Autologous | CT103A (CARTinNS) | Tongji Hospital | Adults with IIM & other autoimmune diseases | 1 | 36 (NMOSD, MG, CIDP, IIM, MS, AE, MOGAD, POEMS ) | infusion of CAR-T following preconditioning with fludarabine and cyclophosphamide | CHINA | NCT04561557 | chuanqin@tjh.tjmu.edu.cn | 22/9/2020 | 22/2/2027 | 31/5/2027 | |||||||||||||
33 | CD19 CAR-T Autologous | CD19 CAR-T | Chongqing Precision Biotech Co | Adults with DM & other autoimmune diseases | 1 | 24(SLE, SS, SScl, DM, ANCA Vasculitis ) | Single IV infusion CAR-T | CHINA | NCT06056921 | 1315710223@qq.com | 31/8/2023 | 31/12/2025 | 31/8/2025 | |||||||||||||
34 | CD19 CAR-T Autologous | RD06-04 | Nanjing Bioheng Biotech | Adults with IIM & other autoimmune diseases | 1 | 20(SLE, SSc, AAV, IIM, and pSS) | Single IV infusion CAR-T | CHINA | NCT06548607 | peng.yu@bioheng.com ming.gao@bioheng.com | 29/7/2024 | 29/7/2026 | 29/7/2027 | |||||||||||||
35 | CD19 CAR-T Autologous | CD19 CAR-T | Chongqing Precision Biotech Co | Children with refractory JDM | 1 | 10 | Lymphodepletion, IV infusion CAR-T | CHINA | NCT06569472 | meipinglu@zju.edu.cn | 2/7/2024 | 31/7/2027 | 31/7/2028 | |||||||||||||
36 | CD19 CAR-T Allogenic | Anti-CD19 UCAR-T cells | Chongqing Precision Biotech Co | Children with refractory JDM | 1 | 18 | Lymphodepletion, IV infusion CAR-T | CHINA | NCT06686524 | meipinglu@zju.edu.cn | 11/11/2024 | 10/11/2026 | 10/11/2027 | |||||||||||||
37 | CD19 CAR-T Allogenic | UTAA09 | PersonGen BioTherapeutics (Suzhou) | Adults with IIM & other autoimmune diseases ( not yet recruiting | 1 | 10 ( IIM, SLE, SS, SScl, RA, ITP, PBC) | Single IV infusion CAR-T | CHINA | NCT06417398 | njwujian@163.com | 14/5/2024 | 1/12/2024 | 1/5/2025 | |||||||||||||
38 | CD19 CAR-T Allogenic | RD06-04 | Nanjing Bioheng Biotech | Adults with IIM & other autoimmune diseases | 1 | 12(SLE, SSc, AAV, IIM, and pSS) | Single IV infusion CAR-T | CHINA | NCT06549296 | peng.yu@bioheng.com ming.gao@bioheng.com | 31/8/2024 | 1/8/2026 | 1/8/2027 | |||||||||||||
39 | CD19 CAR-T Allogenic | CD19-CAR-DNT (RJMty19) Â | RenJi Hospital | Adults with IIM & other autoimmune diseases | 1 | 48(SLE, SSc IIM, and ANCA Vas) | Single IV infusion CAR-T | CHINA | NCT06285539 | fuqiong@renji.com | 30/10/2023 | 1/6/2024 | 1/6/2026 | |||||||||||||
40 | CD19 CAR-T Allogenic | BRL-301 | Bioray Laboratories | Adults with IIM & other autoimmune diseases (by invitation only) | N/A | 15(SLE, SS, SSc, IIM, ANCA Vasculitis, Antiphospholipid syndrome ) | Single IV infusion CAR-T | CHINA | NCT05859997 | N/A | 5/17/2023 | 5/27/2024 | 5/27/2025 | |||||||||||||
41 | Anti-CD19 CAR-NK Allogenic | n/a | Zhejiang University | Adults with IIM & other autoimmune diseases ( not yet recruiting) | 1 | 15( SS, SSc, IIM, ANCA Vasculitis, Antiphospholipid syndrome ) | Lymphodepletion then dose-escalated 3 IV infusions CAR-NK | CHINA | NCT06614270 | jingxue@zju.edu.cn | 11/20/2024 | 11/1/2025 | 11/1/2027 | |||||||||||||
42 | Anti-CD19 CAR-NK allogenic | NKX019 /Cyclophosphamide (Ntrust) | Nkarta, Inc. | Adults with IIM & other autoimmune diseases | 1 | 90 ( SSc, IIM, ANCA-AAV | Lymphodepletion then dose-escalation 3 infusions CAR-NK | US | NCT06733935 | medmonitor@nkartatx.com | 11/4/2024 | 10.2028 | 10.2028 |
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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