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DRUG CLASS:

JAK3 inhibitor

13d
Ritlecitinib in CTCL (clinicaltrials.gov)
P2, N=20, Recruiting, Icahn School of Medicine at Mount Sinai | Phase classification: P2a --> P2
Phase classification
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TNFRSF8 (TNF Receptor Superfamily Member 8)
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TNFRSF8 positive
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Litfulo (ritlecitinib)
17d
New P2 trial
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tofacitinib
22d
Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19) (clinicaltrials.gov)
P2, N=0, Withdrawn, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | N=168 --> 0 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jan 2024 --> Apr 2024
Enrollment change • Trial withdrawal • Trial primary completion date
25d
Enrollment open • Adherence
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tofacitinib
30d
Trial completion
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tofacitinib
1m
Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy (clinicaltrials.gov)
P2, N=30, Recruiting, Icahn School of Medicine at Mount Sinai
New P2 trial
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Litfulo (ritlecitinib)
1m
Model-Informed Assessment of Probability of Phase 3 Success for Ritlecitinib in Patients with Moderate-to-Severe Ulcerative Colitis. (PubMed, Clin Pharmacol Ther)
The probabilities of achieving target modified clinical remission and endoscopic improvement outcomes at both weeks 8 and 52 for ritlecitinib 100 mg once daily was 74.8%. Model-based assessment mitigated some of the risk associated with proceeding to pivotal phase 3 trials with dosing regimens of which there was limited clinical experience.
P3 data • Journal
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JAK3 (Janus Kinase 3)
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Litfulo (ritlecitinib)
1m
Enrollment change • HEOR • Combination therapy
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tofacitinib
1m
Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis (clinicaltrials.gov)
P2/3, N=275, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | Phase classification: P3 --> P2/3
Enrollment closed • Phase classification
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tofacitinib
1m
A First in Human Single and Multiple Ascending Dose and Open Label Food Effect Study of OR-101 in Healthy Subjects (clinicaltrials.gov)
P1, N=0, Withdrawn, Ornovi, Inc. | N=128 --> 0 | Trial completion date: Jun 2024 --> Feb 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jun 2024 --> Feb 2024
Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date
1m
Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis (clinicaltrials.gov)
P=N/A, N=24, Not yet recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University | Trial completion date: Feb 2022 --> Dec 2025 | Initiation date: Sep 2021 --> May 2024 | Trial primary completion date: Jan 2022 --> Jun 2025
Trial completion date • Trial initiation date • Trial primary completion date
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tofacitinib
1m
Trial completion
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Litfulo (ritlecitinib)
2ms
Jaktinib Hydrochloride Cream For Atopic Dermatitis (clinicaltrials.gov)
P1/2, N=107, Completed, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Active, not recruiting --> Completed
Trial completion
2ms
Successful treatment with tofacitinib for anti-melanoma differentiation-associated gene 5 antibody-positive juvenile dermatomyositis: case reports and review of the literature. (PubMed, Immunol Med)
Except for one case of herpes simplex meningitis, the other cases, including ours, had improved disease activity without severe adverse events, and steroids and immunosuppressive medicines could be tapered. Tofacitinib could be considered an available therapy for refractory anti-MDA5 Ab + JDM.
Review • Journal
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IFIH1 (Interferon Induced With Helicase C Domain 1)
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tofacitinib
2ms
Revealing innovative JAK1 and JAK3 inhibitors: a comprehensive study utilizing QSAR, 3D-Pharmacophore screening, molecular docking, molecular dynamics, and MM/GBSA analyses. (PubMed, Front Mol Biosci)
Notably, the pharmacokinetic, physicochemical properties, and biological activities of the selected compounds (As compounds ZINC79189223 and ZINC66252348) were found to be consistent with their therapeutic effects in RA, owing to their non-toxic, cholinergic nature, absence of P-glycoprotein, high gastrointestinal absorption, and ability to penetrate the blood-brain barrier. Furthermore, ADMET properties were assessed, and molecular dynamics and MM/GBSA analysis revealed stability in these molecules.
Journal
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JAK1 (Janus Kinase 1) • JAK3 (Janus Kinase 3)
2ms
KIC-START: Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes. (clinicaltrials.gov)
P=N/A, N=60, Recruiting, Pfizer | Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Oct 2024
Trial completion date • Trial primary completion date • Real-world evidence • Patient reported outcomes • Real-world
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tofacitinib
2ms
A Study to Evaluate the Effect of Jaktinib on QT/QTc Interval in Healthy Participants (clinicaltrials.gov)
P1, N=32, Recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting --> Recruiting
Enrollment open
2ms
Changes of Depression After First-year of Tofacitinib in RA Patients (clinicaltrials.gov)
P=N/A, N=73, Completed, Pfizer | Active, not recruiting --> Completed
Trial completion
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tofacitinib
2ms
A Study to Learn About the Study Medicine (Called Tofacitinib) in People With Psoriatic Arthritis (clinicaltrials.gov)
P=N/A, N=1, Completed, Pfizer | Trial primary completion date: Mar 2024 --> Oct 2023 | Recruiting --> Completed | Trial completion date: Mar 2024 --> Oct 2023
Trial completion • Trial completion date • Trial primary completion date
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tofacitinib
2ms
A Safety and Tolerability Study of Jaktinib (clinicaltrials.gov)
P1, N=26, Recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Trial completion date: Nov 2023 --> Nov 2025 | Trial primary completion date: May 2023 --> May 2025
Trial completion date • Trial primary completion date
2ms
Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus (clinicaltrials.gov)
P1, N=7, Completed, National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting --> Completed | N=10 --> 7
Trial completion • Enrollment change
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tofacitinib
2ms
Tofacitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Dose Escalation Study (clinicaltrials.gov)
P4, N=92, Completed, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
New P4 trial
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tofacitinib
2ms
Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis (clinicaltrials.gov)
P=N/A, N=130, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
New trial • Stroma
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MMP3 (Matrix metallopeptidase 3)
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methotrexate • tofacitinib
2ms
Real-world evaluation of persistence, effectiveness and usage patterns of tofacitinib in treatment of psoriatic arthritis in Australia. (PubMed, Clin Rheumatol)
In this Australian real-world dataset, tofacitinib was more frequently used in later lines and among a slightly higher proportion of female patients than IL-17Ai or TNFi. Overall, treatment persistence was similar for tofacitinib, IL-17Ai and TNFi, but tofacitinib exhibited longer persistence than TNFi in a matched population. Key Points • This is the first, large real-world study from Australia investigating the demographics, treatment patterns and comparative treatment persistence of patients with psoriatic arthritis (PsA) treated with tofacitinib and biologic disease-modifying drugs (bDMARDs). • The study suggests that tofacitinib is an effective intervention in PsA with at least comparable persistence to bDMARDs: tumour necrosis factor inhibitors (TNFi) and interleukin-17 A inhibitors (IL-17Ai).
Journal • HEOR • Real-world evidence • Real-world
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IL17A (Interleukin 17A)
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tofacitinib
2ms
VX-509 attenuates the stemness characteristics of colorectal cancer stem-like cells by regulating the epithelial-mesenchymal transition through Nodal/Smad2/3 signaling. (PubMed, World J Stem Cells)
VX-509 prevents the EMT process in CCSCs by inhibiting the transcription and protein expression of Nodal, and inhibits the dedifferentiated self-renewal of CCSCs.
Journal
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NODAL (Nodal Growth Differentiation Factor)
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NODAL overexpression
2ms
Study to Evaluate the Safety and Efficacy of Jaktinib in Adults With Alopecia Areata (clinicaltrials.gov)
P3, N=420, Active, not recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date
2ms
A Phase 2 Study of Jaktinib in Participants With Moderate to Severe Psoriasis (clinicaltrials.gov)
P2, N=123, Active, not recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Enrollment closed • Trial completion date • Trial primary completion date
2ms
A Phase III Extended Clinical Trial of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis (clinicaltrials.gov)
P3, N=400, Recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Trial primary completion date: Dec 2023 --> Dec 2024
Trial primary completion date
2ms
A Study With Jaktinib Hydrochloride Cream Applied Topically to Subjects With Alopecia Areata (clinicaltrials.gov)
P1/2, N=160, Active, not recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Recruiting --> Active, not recruiting | N=120 --> 160 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
2ms
Jaktinib Hydrochloride Cream For Atopic Dermatitis (clinicaltrials.gov)
P1/2, N=107, Active, not recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date
2ms
A Study of Jaktinib for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease. (clinicaltrials.gov)
P2, N=60, Not yet recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
Trial completion date • Trial primary completion date
3ms
Double Blind, Placebo-controlled Trial to Establish Safety and Efficacy of Ritlecitinib in Celiac Disease Patients in Remission (clinicaltrials.gov)
P2, N=30, Recruiting, Massachusetts General Hospital | Trial completion date: Jan 2025 --> Aug 2025 | Trial primary completion date: Jan 2024 --> Aug 2025
Trial completion date • Trial primary completion date
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Litfulo (ritlecitinib)
3ms
Litfulo Capsules Special Investigation (clinicaltrials.gov)
P=N/A, N=850, Not yet recruiting, Pfizer
New trial
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Litfulo (ritlecitinib)
3ms
Enrollment open
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Litfulo (ritlecitinib)
3ms
A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA (clinicaltrials.gov)
P3, N=100, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting
Enrollment closed
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tofacitinib
3ms
CRI-RA: Combination of Baricitinib and Anti-TNF in Rheumatoid Arthritis (clinicaltrials.gov)
P3, N=178, Recruiting, University Hospital, Bordeaux | Trial completion date: Jul 2025 --> Dec 2025 | Trial primary completion date: Jul 2025 --> Dec 2025
Trial completion date • Trial primary completion date
3ms
Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov)
P2, N=91, Active, not recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date
3ms
TOUR: Tofacitinib Response in Ulcerative Colitis - a Real World Prospective Multi-center Study (clinicaltrials.gov)
P=N/A, N=103, Terminated, University of North Carolina, Chapel Hill | N=200 --> 103 | Trial completion date: Dec 2024 --> Jan 2024 | Enrolling by invitation --> Terminated; Futility; recruitment to slow to justify longer study duration
Enrollment change • Trial completion date • Trial termination • Real-world evidence • Real-world
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tofacitinib
3ms
New P4 trial
3ms
Enrollment open
|
tofacitinib
3ms
Anti-MDA5 Antibody-positive Clinically Amyopathic Dermatomyositis with Rapidly Progressing Interstitial Lung Disease Successfully Treated by Initiation of Combined Immunosuppressive Therapy Plus Plasma Exchange and Subsequently Switching Tacrolimus to Tofacitinib. (PubMed, Intern Med)
Furthermore, switching from tacrolimus to tofacitinib resulted in disease remission. Recognition of the inverse Gottron's sign may allow for the earlier diagnosis of anti-MDA5 Ab-positive dermatomyositis, and early addition of PE to triple therapy and administration of tofacitinib in refractory cases may be effective for anti-MDA5 Ab-positive CADM with RP-ILD under life-threatening conditions.
Journal
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IFIH1 (Interferon Induced With Helicase C Domain 1)
|
tofacitinib