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DRUG CLASS:

TNFα inhibitor

1d
Daratumumab for Patients With Light Chain Amyloidosis (clinicaltrials.gov)
P=N/A, N=100, Recruiting, Nanjing University School of Medicine
New trial
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pomalidomide • Darzalex Faspro (daratumumab/hyaluronidase)
2d
ADDORA: Adalimumab Drug Optimisation in Rheumatoid Arthritis Using Therapeutic Drug Monitoring (clinicaltrials.gov)
P4, N=267, Recruiting, Reade Rheumatology Research Institute | Trial primary completion date: Dec 2023 --> Dec 2024
Trial primary completion date
2d
MCLENA-1: A Clinical Trial for the Assessment of Lenalidomide in Amnestic MCI Patients (clinicaltrials.gov)
P2, N=30, Recruiting, St. Joseph's Hospital and Medical Center, Phoenix | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2023 --> Sep 2024
Trial completion date • Trial primary completion date
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IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL10 (Interleukin 10) • IL1B (Interleukin 1, beta)
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lenalidomide
3d
Frontline Lenalidomide for AL Amyloidosis Involving Myocardium (clinicaltrials.gov)
P3, N=2, Completed, Seoul National University Hospital | Unknown status --> Completed | N=30 --> 2
Trial completion • Enrollment change
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NPPB (Natriuretic Peptide B)
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lenalidomide
3d
SAPHIR: Assessment of Predictive Factors for Persistence of Treatment After Substitution of Reference Adalimumab With the Fresenius Kabi Adalimumab Biosimilar in Patients With Chronic Inflammatory Diseases (clinicaltrials.gov)
P=N/A, N=600, Recruiting, Fresenius Kabi, France | Trial completion date: Nov 2024 --> Sep 2025 | Trial primary completion date: Nov 2023 --> Sep 2025
Trial completion date • Trial primary completion date
3d
Trial primary completion date
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Entyvio (vedolizumab)
3d
The Effect of Sulfasalazine on CRH Levels in Pregnant Women (clinicaltrials.gov)
P2, N=50, Recruiting, Rutgers, The State University of New Jersey | Trial completion date: Jul 2024 --> Jun 2026 | Trial primary completion date: Jan 2024 --> Jan 2026
Trial completion date • Trial primary completion date
4d
Trial primary completion date
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pomalidomide
4d
COMBAT-ALS: Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS (clinicaltrials.gov)
P2/3, N=230, Recruiting, MediciNova | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
Trial completion date • Trial primary completion date
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Eyevinal (ibudilast)
8d
Activated and Naïve Allogenic Human Placental Mesenchymal Stromal Cells Exert an Immunomodulatory Effect on Hidradenitis Suppurativa Patient Peripheral Blood Mononuclear Cells. (PubMed, J Interferon Cytokine Res)
The PBMCs of patients with HS were co-cultured with naïve MSCs (n-MSCs), activated with tumor necrosis factor (TNF)-α (10 ng/mL) and interferon (IFN)-γ (10 ng/mL) MSCs (a-MSCs), or adalimumab (30 μg/mL)...Moreover, the preactivation of MSCs with IFN-γ and TNF-α before use can enhance their therapeutic effectiveness. Nevertheless, a larger sample size is imperative to validate these results.
Journal • Immunomodulating • Stroma
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IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL17A (Interleukin 17A) • IL1B (Interleukin 1, beta)
9d
Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients (clinicaltrials.gov)
P4, N=30, Recruiting, Taizhou Mabtech Pharmaceutical Co.,Ltd | Not yet recruiting --> Recruiting
Enrollment open
11d
Trial completion
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lenalidomide
11d
Population Pharmacokinetic Study Based on Quantitative Pharmacology in Patients With Lenalidomide (clinicaltrials.gov)
P=N/A, N=38, Completed, Qianfoshan Hospital | Recruiting --> Completed | N=60 --> 38 | Trial completion date: May 2024 --> May 2023 | Trial primary completion date: Dec 2023 --> May 2023
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
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ABCB1 (ATP Binding Cassette Subfamily B Member 1)
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lenalidomide
11d
Indoxyl sulphate-TNFα axis mediates uremic encephalopathy in rodent acute kidney injury. (PubMed, Acta Pharmacol Sin)
In this study we investigated the CNS behaviors and expression/function of BBB OAT3 in AKI rats and mice, which received intraperitoneal injection of cisplatin 8 and 20 mg/kg, respectively...The alterations caused by TNFα and CMs in vitro, and by AKI and TNFα in vivo were abolished by infliximab, a monoclonal antibody designed to intercept and neutralize TNFα, suggesting that AKI impaired the expressions of OAT3, synaptophysin and MAP2 in the brain via IS-induced TNFα release from macrophages or microglia (termed as IS-TNFα axis)...We conclude that AKI inhibits the expressions of OAT3, synaptophysin and MAP2 due to IS-induced TNFα release from macrophages or microglia. TNFα impairs the expressions of OAT3, synaptophysin and MAP2 partly via activating NF-κB pathway and inhibiting Nrf2-HO-1 pathway.
Preclinical • Journal
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TNFA (Tumor Necrosis Factor-Alpha) • SYP (Synaptophysin) • RELA (RELA Proto-Oncogene)
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RELA expression
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cisplatin
12d
Multiple myeloma with IgH::MYC and multiple extramedullary lesions (PubMed, Rinsho Ketsueki)
Complete remission was maintained for over one year with lenalidomide maintenance therapy. A solitary IgH::MYC chromosomal translocation is extremely rare in multiple myeloma and may be associated with high tumor proliferative capacity, multiple extramedullary lesions, and poor prognosis. Combined therapeutic modalities with novel and conventional chemotherapy and radiation might be a promising treatment strategy for patients with this type of multiple myeloma.
Journal
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SDC1 (Syndecan 1)
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MYC positive
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lenalidomide
12d
Trial primary completion date • Metastases
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dacarbazine • Fibromun (onfekafusp alfa)
12d
Enrollment change • Trial withdrawal • Combination therapy
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MGMT (6-O-methylguanine-DNA methyltransferase)
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lomustine • Fibromun (onfekafusp alfa)
12d
FIBROSARC: A Study Comparing the Efficacy of L19TNF+Doxorubicin vs Doxorubicin Alone as First-line Therapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma (clinicaltrials.gov)
P3, N=102, Recruiting, Philogen S.p.A. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025
Trial completion date • Trial primary completion date • Metastases
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doxorubicin hydrochloride • Fibromun (onfekafusp alfa)
12d
DOXO75: Dose Finding Study of L19TNF and Doxorubicin in Patients With STS (clinicaltrials.gov)
P1, N=2, Active, not recruiting, Philogen S.p.A. | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
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doxorubicin hydrochloride • Fibromun (onfekafusp alfa)
12d
Pediatric Arthritis Study of Certolizumab Pegol (clinicaltrials.gov)
P3, N=193, Completed, UCB BIOSCIENCES GmbH | Active, not recruiting --> Completed
Trial completion
12d
Trial primary completion date
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MGMT (6-O-methylguanine-DNA methyltransferase)
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IDH wild-type
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lomustine • Fibromun (onfekafusp alfa)
15d
Etanercept-synthesizing adipose-derived stem cell secretome: A promising therapeutic option for inflammatory bowel disease. (PubMed, World J Gastrointest Surg)
These results suggest that the secretome derived from ASCs that synthesize etanercept has potential as a therapeutic agent for the treatment of IBD, potentially enhancing treatment efficacy by merging the anti-inflammatory qualities of the ASC secretome with etanercept's targeted approach to better address the multifaceted pathophysiology of IBD.
Journal
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IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CCL2 (Chemokine (C-C motif) ligand 2)
15d
Trial completion date
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lenalidomide
15d
Trial completion date
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lenalidomide • bortezomib • Hemady (dexamethasone tablets)
16d
Protective effects of sinomenine against dextran sulfate sodium-induced ulcerative colitis in rats via alteration of HO-1/Nrf2 and inflammatory pathway. (PubMed, Inflammopharmacology)
The results clearly indicate that sinomenine demonstrated a protective effect against DSS-induced inflammation, potentially through the modulation of inflammatory pathways and gut microbiota.
Preclinical • Journal
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IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • ICAM1 (Intercellular adhesion molecule 1) • IL10 (Interleukin 10) • MMP2 (Matrix metallopeptidase 2) • IL18 (Interleukin 18) • IL17A (Interleukin 17A) • IL1B (Interleukin 1, beta) • MMP1 (Matrix metallopeptidase 1) • NLRP3 (NLR Family Pyrin Domain Containing 3) • RIPK1 (Receptor Interacting Serine/Threonine Kinase 1) • VCAM1 (Vascular Cell Adhesion Molecule 1)
16d
Assessment of the activity of the immune system in patients with inflammatory bowel diseases and asymptomatic COVID-19. (PubMed, Prz Gastroenterol)
However, the effect of the applied treatment on the concentration of some cytokines was found: a negative association of infliximab, vedolizumab, and prednisone with IL-2, a positive correlation of steroids, thiopurines with IL-10, and in the case of tumor necrosis factor-α (TNF-α), negative with infliximab, and positive with vedolizumab. The increased concentration of IL-2 may result from its regulatory role in inhibiting excessive activation of the immune system; however, considering the studies of patients with severe COVID-19, its role in the initial phase of SARS-CoV-2 infection requires further research.
Journal
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IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • IL2 (Interleukin 2) • IL10 (Interleukin 10) • IL17A (Interleukin 17A) • IL1A (Interleukin 1, alpha) • IL23A (Interleukin 23 Subunit Alpha) • IL13 (Interleukin 13) • IL1B (Interleukin 1, beta) • IL4 (Interleukin 4) • IL5 (Interleukin 5)
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prednisone • Entyvio (vedolizumab)
17d
An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis (clinicaltrials.gov)
P2, N=94, Enrolling by invitation, Xentria, Inc. | Not yet recruiting --> Enrolling by invitation
Enrollment open
18d
Molecular Profiling of Axial Spondyloarthritis Patients Reveals an Association between Innate and Adaptive Cell Populations and Therapeutic Response to Tumor Necrosis Factor Inhibitors. (PubMed, Biomolecules)
In conclusion, innate and adaptive immune cell type composition at baseline may be a major contributor to response to adalimumab in axSpA patients. A model including clinical and gene expression variables should also be considered.
Journal
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APOA1 (Apolipoprotein A-I) • AFF3 (AF4/FMR2 Family Member 3) • CRP (C-reactive protein)
19d
Novel bispecific nanobody mitigates experimental intestinal inflammation in mice by targeting TNF-α and IL-23p19 bioactivities. (PubMed, Clin Transl Med)
A bispecific nanobody (BsNb) was created to target TNF-α and IL-23p19, exhibiting high affinity and remarkable stability. BsNb-Fc inhibited the release of cytokines in CD4+T cells during co-culture experiments. BsNb-Fc effectively alleviated colitis severity in mouse model with acute colitis induced by DSS or TNBS, outperforming the IFX&UST combination.
Preclinical • Journal
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TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • IL23A (Interleukin 23 Subunit Alpha)
19d
Engineered therapeutic antibodies with mannose 6-phosphate analogues as a tool to degrade extracellular proteins. (PubMed, Front Immunol)
The improvement of the therapeutic potential by AMFA engineering was investigated using two antibodies directed against soluble antigens: infliximab (IFX), directed against tumor necrosis factor α (TNF-α), and bevacizumab (BVZ), directed against the vascular endothelial growth factor (VEGF). These results demonstrate that AMFA grafting induces the degradation of soluble antigens and a significant increase in the therapeutic efficacy. Engineering with mannose 6-phosphate analogues has the potential to develop a new class of antibodies for autoimmune and inflammatory diseases.
Journal
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TNFA (Tumor Necrosis Factor-Alpha)
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Avastin (bevacizumab)
22d
Enrollment change
22d
An in vitro study elucidating the synergistic effects of aqueous cinnamon extract and an anti-TNF-α biotherapeutic: implications for a complementary and alternative therapy for non-responders. (PubMed, BMC Complement Med Ther)
In conclusion, cinnamon acted synergistically with infliximab to mitigate inflammation when used as an extract. Purified bioactive TCA also showed synergistic activity. Thus, aCE, or cinnamon bioactive may be used as a CAM to improve patients' quality of life.
Preclinical • Journal
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JAK2 (Janus kinase 2) • BCL2L1 (BCL2-like 1) • STAT3 (Signal Transducer And Activator Of Transcription 3) • ICAM1 (Intercellular adhesion molecule 1) • TIMP1 (Tissue inhibitor of metalloproteinases 1) • TLR4 (Toll Like Receptor 4) • MMP1 (Matrix metallopeptidase 1) • VCAM1 (Vascular Cell Adhesion Molecule 1) • MMP3 (Matrix metallopeptidase 3)
23d
TNFRSF1B Signaling Blockade Protects Airway Epithelial Cells from Oxidative Stress. (PubMed, Antioxidants (Basel))
Moreover, a blockade of TNFR signaling through its ligand lymphotoxin-α (LTA), overexpressed in airway epithelial cells under oxidative stress conditions, using the anti-tumor necrosis factor (TNF) biologic etanercept significantly increased the viability of these cells from a toxic oxidizing agent. Furthermore, bioinformatic analyses considering our previous RNA interference (RNAi) screening output highlight the relevance of TNFRSF1B and of other genes within the TNF pathway leading to epithelial cell death. Thus, the inhibition of the LTα3-TNFR2 axis could represent a useful therapeutic strategy to protect the respiratory airway epithelial lining from the oxidative stress challenge because of recurrent infection/inflammation cycles faced by CF patients.
Journal
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TNFA (Tumor Necrosis Factor-Alpha) • TNFRSF1B (TNF Receptor Superfamily Member 1B)
23d
New P2 trial • Combination therapy
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lomustine • Fibromun (onfekafusp alfa)
23d
Application of N-of-1 Rheumatoid Arthritis (clinicaltrials.gov)
P=N/A, N=18, Not yet recruiting, Tufts Medical Center | Trial completion date: Jan 2025 --> May 2025 | Initiation date: Jan 2024 --> May 2024 | Trial primary completion date: Jan 2025 --> May 2025
Trial completion date • Trial initiation date • Trial primary completion date
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CRP (C-reactive protein)
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Kevzara (sarilumab)
24d
DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov)
P2, N=715, Recruiting, Janssen Research & Development, LLC | Trial completion date: Oct 2030 --> Mar 2029
Trial completion date • Combination therapy
24d
DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov)
P2, N=550, Recruiting, Janssen Research & Development, LLC | Trial completion date: Aug 2030 --> Mar 2029
Trial completion date • Combination therapy
25d
ECOG-ACRIN-EAQ172: Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis (clinicaltrials.gov)
P2, N=1, Terminated, ECOG-ACRIN Cancer Research Group | Trial completion date: Jul 2025 --> Dec 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2025 --> Dec 2023; Slow accrual
Trial completion date • Trial termination • Trial primary completion date • IO biomarker
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prednisone • methylprednisolone acetate
25d
Comparison between super-responders and non-super-responders in psoriasis under adalimumab treatment: a real-life cohort study on the effectiveness and drug survival over one-year. (PubMed, J Dermatolog Treat)
Super-responders treated with adalimumab have a higher rate of being female and fewer comorbidities. And super-responders have better PASI responses than non-super-responders, whether the patients were treated with adalimumab or switched to IL-17A inhibitors.
Journal
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IL17A (Interleukin 17A)
28d
Deep analysis of skin molecular heterogeneities and their significance on the precise treatment of patients with psoriasis. (PubMed, Front Immunol)
Notably, subtypes A and B presented good responses to methotrexate and interleukin-12/23 inhibitors (ustekinumab) but inadequate responses to tumor necrosis factor-α inhibitors and interleukin-17A receptor inhibitors. Contrastly, subtype C exhibited excellent responses to tumor necrosis factor-α inhibitors (etanercept) and interleukin-17A receptor inhibitors (brodalumab) but not methotrexate and interleukin-12/23 inhibitors. Psoriasis patients can be assorted into three subtypes with different molecular and cellular characteristics based on the heterogeneity of the skin's immune cells and the stroma, determining the clinical responses of conventional therapies.
Journal
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IL17A (Interleukin 17A)
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methotrexate
30d
Pembrolizumab + Infliximab for Metastatic Melanoma (clinicaltrials.gov)
P2, N=36, Recruiting, Massachusetts General Hospital | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2023 --> Jun 2025
Trial completion date • Trial primary completion date • Adverse events • Combination therapy • Metastases
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Keytruda (pembrolizumab)