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3 Diseases |  |
5 Trials |
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5 Trials |  |
110 News |  |
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- A Systematic Review of Pharmacological Interventions for Hidradenitis Suppurativa: A Focus on Clinical Response, Quality of Life, and Safety () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_1258;
The results of this review demonstrate the possibility of highly personalized treatment approaches for HS management, including adalimumab and povorcitinib. The optimization of HS care requires further research on long-term outcomes.
- || brepocitinib (PF-06700841) / Priovant Therap
P2a data, Journal: A phase 2a trial of brepocitinib for cicatricial alopecia. (Pubmed Central) - Oct 27, 2024
Brepocitinib significantly reduces CCL5 expression and was well tolerated at week 24, meeting co-primary endpoints. Brepocitinib reduces inflammatory biomarker expression and improves clinical severity, while maintaining favorable safety profile.
- |||||| brepocitinib (PF-06700841) / Priovant Therap
Enrollment open, Enrollment change, Trial completion date: CLARITY: A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis (clinicaltrials.gov) - Oct 22, 2024
P3, N=300, Recruiting, Sponsor: Priovant Therapeutics, Inc.
Brepocitinib reduces inflammatory biomarker expression and improves clinical severity, while maintaining favorable safety profile. Not yet recruiting --> Recruiting | N=220 --> 300 | Trial completion date: Aug 2027 --> Feb 2028
- brepocitinib (PF-06700841) / Priovant Therap
Safety and Efficacy of Brepocitinib, a TYK2/JAK1 Inhibitor, in Active Noninfectious Uveitis: A 52-Week Phase 2 Study (NEPTUNE) (S405) - Sep 24, 2024 - Abstract #AAO2024AAO_1571;
Adverse event rate was similar in both arms. Conclusion Brepocitinib demonstrated dose-dependent, clinically meaningful efficacy and was well tolerated, with a safety profile consistent with prior brepocitinib studies and pharmacologic class.
- | brepocitinib (PF-06700841) / Priovant Therap
Phase classification: A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) (clinicaltrials.gov) - Sep 4, 2024
P2, N=350, Completed, Sponsor: Pfizer
Conclusion Brepocitinib demonstrated dose-dependent, clinically meaningful efficacy and was well tolerated, with a safety profile consistent with prior brepocitinib studies and pharmacologic class. Phase classification: P2b --> P2
- | brepocitinib (PF-06700841) / Priovant Therap
Preclinical, Journal: Janus Kinase Inhibitor Brepocitinib Rescues Myelin Phagocytosis Under Inflammatory Conditions: In Vitro Evidence from Microglia and Macrophage Cell Lines. (Pubmed Central) - Aug 21, 2024
and LPS. They also indicate that the resolution of inflammation is important for the clearance of cellular debris by macrophages and subsequent regenerative processes.
- || brepocitinib (PF-06700841) / Priovant Therap
P2 data, Journal: Validation of the Peak Pruritus-Numerical Rating Scale in patients with chronic plaque psoriasis: results from a phase 2 study. (Pubmed Central) - Aug 20, 2024
P2b
They also indicate that the resolution of inflammation is important for the clearance of cellular debris by macrophages and subsequent regenerative processes. PP-NRS is a reliable, practical test for assessing pruritus in mild-to-moderate PsO clinical trials.
- Efficacy and Safety Profile of Small Molecules for Induction and Maintenance of Remission in Ulcerative Colitis: A Systematic Review of Randomised Control Trials (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_1329;
These agents are effective resulting in early clinical remission, as determined by the assessment of total Mayo score and endoscopic normalization and they also help achieve corticosteroid-free remission. Further assessment showed significantly improved HRQoL and IBDQ (Inflammatory Bowel Disease Questionnaire) outcomes.
- ||||| brepocitinib (PF-06700841) / Priovant Therap
Enrollment closed: VALOR: A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis (clinicaltrials.gov) - Aug 6, 2024
P3, N=241, Active, not recruiting, Sponsor: Priovant Therapeutics, Inc.
Further assessment showed significantly improved HRQoL and IBDQ (Inflammatory Bowel Disease Questionnaire) outcomes. Recruiting --> Active, not recruiting
- || brepocitinib (PF-06700841) / Priovant Therap
Review, Journal: Brepocitinib, a potent and selective TYK2/JAK1 inhibitor: scientific and clinical rationale for dermatomyositis. (Pubmed Central) - Jul 15, 2024
Therefore, there is a strong scientific and clinical rationale for the utility and potential effectiveness of brepocitinib in the treatment of DM patients. Currently, the safety, tolerability, and efficacy of brepocitinib is being evaluated in the largest (n=225) double-blind placebo-controlled phase 3 trial in DM patients to date (VALOR - NCT0543726).
- || ropsacitinib (PF-06826647) / Priovant Therap, Sotyktu (deucravacitinib) / BMS, brepocitinib (PF-06700841) / Priovant Therap
Review, Journal: Therapeutic Potential of Targeting the JAK/STAT Pathway in Psoriasis: Focus on TYK2 Inhibition. (Pubmed Central) - Jun 19, 2024
Due to the selective TYK2 blockade allowing the inhibition of key cytokine-mediated signals, such as those induced by IL-12 and IL-23, anti-TYK2 agents appear to be very promising as the safety profile seems to be superior compared with pan-JAK inhibitors. The aim of our review is to thoroughly explore the rationale behind the usage of JAK inhibitors in PsO, their efficacy and safety profiles, with a special focus on oral TYK2 inhibitors, as well as to provide a forward-looking update on novel therapeutic strategies targeting the TYK2 pathway in psoriasis.
- | brepocitinib (PF-06700841) / Priovant Therap
Journal: The Metabolism and Disposition of Brepocitinib in Humans and Characterization of the Formation Mechanism of an Aminopyridine Metabolite. (Pubmed Central) - Jun 17, 2024
Time dependent inhibition and trapping studies with M1 yielded insights into the mechanism of this unusual and unexpected instability. Significance Statement This work describes the mass balance and metabolic profile of brepocitinib in human, a JAK1/TYK2 inhibitor being developed for treatment of autoimmune diseases.
- brepocitinib (PF-06700841) / Priovant Therap
The role of JAK/STAT signaling in neutrophilic airway inflammation (PS-14; Poster board no. 17) - May 31, 2024 - Abstract #ERS2024ERS_4804;
Isolated neutrophils were pretreated with Brepocitinib, a TYK2-JAK1-JAK2 inhibitor, and further stimulated with IL-17 and IL-23 for migration... Our preliminary data indicates the involvement of the IL-23/IL-17 axis in neutrophilic airway inflammation and related corticosteroid resistance, highlighting the potential of JAK inhibitors as an additional therapeutic approach.
- brepocitinib (PF-06700841) / Priovant Therap
New P2 trial: A 12-Week Open-Label Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Skin-Predominant Dermatomyositis (clinicaltrials.gov) - May 30, 2024
P2, N=5, Not yet recruiting, Sponsor: Priovant Therapeutics, Inc.
- |||||||||| brepocitinib (PF-06700841) / Priovant Therap
New P3 trial: CLARITY: A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis (clinicaltrials.gov) - May 28, 2024
P3, N=220, Not yet recruiting, Sponsor: Priovant Therapeutics, Inc.
- || Litfulo (ritlecitinib) / Pfizer, Olumiant (baricitinib) / Eli Lilly, brepocitinib (PF-06700841) / Priovant Therap
Review, Journal: Exploring Janus kinase inhibitors for alopecia areata: a comprehensive review. (Pubmed Central) - May 23, 2024
Collectively, the reviewed studies affirm JAK inhibitors, particularly Baricitinib, as promising treatments for moderate to severe alopecia areata. These inhibitors exhibit superior efficacy, as indicated by notable reductions in SALT scores, and are well-tolerated, with predominantly mild and manageable adverse events.
- | Journal: Efficacy and safety of pharmacological treatment of psoriatic arthritis: a systematic literature research informing the 2023 update of the EULAR recommendations for the management of psoriatic arthritis. (Pubmed Central) - May 15, 2024
These inhibitors exhibit superior efficacy, as indicated by notable reductions in SALT scores, and are well-tolerated, with predominantly mild and manageable adverse events. The results of this SLR informed the task force responsible for the 2023 update of the European Alliance of Associations for Rheumatology recommendations for pharmacological management of PsA.
- brepocitinib (PF-06700841) / Priovant Therap
Brepocitinib improves cicatricial alopecia and downregulates key T-helper biomarkers (De Soto) - Apr 27, 2024 - Abstract #SID2024SID_603;
- brepocitinib (PF-06700841) / Priovant Therap
Molecular effect of brepocitinib in hidradenitis suppurativa (HS) (Cortez A/B) - Apr 27, 2024 - Abstract #SID2024SID_83;
- || brepocitinib (PF-06700841) / Priovant Therap
PK/PD data, Journal: Population pharmacokinetic modeling of oral brepocitinib in healthy volunteers and patients with immuno-inflammatory diseases. (Pubmed Central) - Apr 15, 2024
The PKs of brepocitinib were well-characterized by a two-compartment model with first-order absorption and dose-dependent bioavailability. Several covariates, such as race and sex, were identified to have statistically significant, but not clinically meaningful, effects on the estimated PK parameters.
- UNRAVELING JAK/STAT3 ACTIVATION PATTERNS IN DERMATOMYOSITIS: IMPLICATIONS FOR UNDERSTANDING THE IFN-I SIGNALING PATHWAYS (Poster Tour 1) - Mar 29, 2024 - Abstract #EULAR2024EULAR_1594;
Specifically, DM patients presented a high activation of pSTAT3 that was modified mainly by direct inhibition of JAK-1 and especially TYK-2 in both lymphocytes and monocytes, thus modulating IFN-I effects. Our findings, to be confirmed in larger studies also evaluating phosphorylation of other STATs, pave the way for the clinical use of JAK-inhibitors in DM patients [3], in particular acting on JAK-1/TYK-2 such as the new brepocitinib.
- || brepocitinib topical cream (PF-06700841 topical) / Priovant Therap, brepocitinib (PF-06700841) / Priovant Therap
PK/PD data, Journal: Pharmacokinetic Profile of Brepocitinib with Topical Administration in Atopic Dermatitis and Psoriasis Populations: Strategy to Inform Clinical Trial Design in Adult and Pediatric Populations. (Pubmed Central) - Mar 23, 2024
Our findings, to be confirmed in larger studies also evaluating phosphorylation of other STATs, pave the way for the clinical use of JAK-inhibitors in DM patients [3], in particular acting on JAK-1/TYK-2 such as the new brepocitinib. The relationship between the amount of active drug applied and brepocitinib systemic CTrough, described by LMER, may inform the development strategy for dose optimization in the brepocitinib topical program.
- || ropsacitinib (PF-06826647) / Priovant Therap, Sotyktu (deucravacitinib) / BMS, brepocitinib (PF-06700841) / Priovant Therap
Review, Journal: TYK2: an emerging therapeutic target in rheumatic disease. (Pubmed Central) - Mar 12, 2024
Two other inhibitors of TYK2, brepocitinib and ropsacitinib, are also in earlier stages of clinical trials. Overall, TYK2 inhibitors hold promise for the treatment of a distinct spectrum of autoimmune diseases and could potentially have a safety profile that differs from other JAK inhibitors.
- | brepocitinib (PF-06700841) / Priovant Therap
Journal: Employing zero-inflated beta distribution in an exposure-response analysis of TYK2/JAK1 inhibitor brepocitinib in patients with plaque psoriasis. (Pubmed Central) - Mar 3, 2024
In addition, the developed model exhibited a good predictive capacity with regard to the derived responder metrics (e.g., 75%/90%/100% improvement in PASI score [PASI75/90/100]). Clinical trial simulations indicated that the induction/maintenance dosing paradigm explored in this study does not offer any advantages from an efficacy perspective and that doses of 10, 30, and 60
- brepocitinib (PF-06700841) / Priovant Therap
Brepocitinib induces clinical improvement in patients with cicatricial alopecia and attenuates scalp inflammatory biomarkers (Room 20B) - Mar 1, 2024 - Abstract #AAD2024AAD_3663;
- | ropsacitinib (PF-06826647) / Priovant Therap, zimlovisertib (PF-06650833) / Pfizer, brepocitinib (PF-06700841) / Priovant Therap
Journal: Brepocitinib, Zimlovisertib, and Ropsacitinib in Hidradenitis Suppurativa. (Pubmed Central) - Feb 28, 2024
At 16 weeks, only brepocitinib, a JAK1/TYK2 inhibitor, achieved a higher clinical response than placebo (52% vs. 33%). The other two agents were no better than placebo.
- | Litfulo (ritlecitinib) / Pfizer, brepocitinib (PF-06700841) / Priovant Therap
Phase classification: Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease (clinicaltrials.gov) - Jan 11, 2024
P2, N=244, Completed, Sponsor: Pfizer
The other two agents were no better than placebo. Phase classification: P2a --> P2
- Litfulo (ritlecitinib) / Pfizer, brepocitinib (PF-06700841) / Priovant Therap
Oral ritlecitinib and brepocitinib in patients with moderate to severe active Crohn (Plenary Hall) - Dec 21, 2023 - Abstract #ECCOIBD2024ECCO_IBD_539;
P2b
Other meaningful efficacy endpoints had similar results to the primary endpoint for both therapies. RIT and BRE had an acceptable safety and tolerability profile that was consistent with previous studies.
- Risk-Benefit Appraisal of Systemic JAK Inhibitors for Alopecia Areata: A Comprehensive Meta-Analysis Assessing Safety and Adverse Effects () - Nov 6, 2023 - Abstract #ISDS2023ISDS_235;
The OR for common side effects, notably URI, showed an above 6-fold increase compared to placebos. Nevertheless, the data underscores a restrained risk for severe adverse events.
- |||| brepocitinib (PF-06700841) / Priovant Therap
Trial completion: A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) (clinicaltrials.gov) - Nov 1, 2023
P2b, N=350, Completed, Sponsor: Pfizer
Nevertheless, the data underscores a restrained risk for severe adverse events. Active, not recruiting --> Completed
- |||| Litfulo (ritlecitinib) / Pfizer, brepocitinib (PF-06700841) / Priovant Therap
Trial completion: Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease (clinicaltrials.gov) - Nov 1, 2023
P2a, N=244, Completed, Sponsor: Pfizer
Active, not recruiting --> Completed Active, not recruiting --> Completed
- || brepocitinib (PF-06700841) / Priovant Therap
Biomarker, Trial completion: Dual JAK1/TYK2 Inhibitor for Cicatricial Alopecia (clinicaltrials.gov) - Oct 10, 2023
P2, N=50, Completed, Sponsor: Emma Guttman
Active, not recruiting --> Completed Active, not recruiting --> Completed
- brepocitinib (PF-06700841) / Priovant Therap
Brepocitinib Prevents Type-I Interferon Induced Damage in Cultured Myocytes and Endothelial Cells Indicating a Potential Role in the Treatment of Dermatomyositis (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_3294;
P3
One of the most debilitating aspects of DM is muscle weakness resulting from perifascicular atrophy leading to significant impacts on quality of life for these patients. We report here the ability of brepocitinib to prevent IFN-I induced damage in both myocytes and microvasculature in culture at clinically relevant concentrations, providing further pharmacologic rationale for brepocitinib in the treatment of DM.
- || Review, Journal: [[Translated article]]Janus Kinase Inhibitors in Atopic Dermatitis: New Perspectives. (Pubmed Central) - Sep 7, 2023
We review a number of JAK inhibitors that have been recently approved for use in atopic dermatitis, such as baricitinib, upadacitinib, and abrocitinib, as well as others that are currently in the pipeline or under development, such as gusacitinib, delgocitinib, ruxolitinib, brepocitinib, tofacitinib, and cerdulatinib. The use of JAK inhibitors to block the signaling of numerous cytokines with a critical role in the pathogenesis of atopic dermatitis has revolutionized the treatment of this pathogenically complex, phenotypically heterogeneous skin disease.
- || Review, Journal: Janus Kinase Inhibitors in Atopic Dermatitis: New Perspectives. (Pubmed Central) - Sep 7, 2023
We review a number of JAK inhibitors that have been recently approved for use in atopic dermatitis, such as baricitinib, upadacitinib, and abrocitinib, as well as others that are currently in the pipeline or under development, such as gusacitinib, delgocitinib, ruxolitinib, brepocitinib, tofacitinib, and cerdulatinib. The use of JAK inhibitors to block the signaling of numerous cytokines with a critical role in the pathogenesis of atopic dermatitis has revolutionized the treatment of this pathogenically complex, phenotypically heterogeneous skin disease.
- | brepocitinib (PF-06700841) / Priovant Therap
Biomarker, Enrollment closed: Dual JAK1/TYK2 Inhibitor for Cicatricial Alopecia (clinicaltrials.gov) - Aug 3, 2023
P2, N=50, Active, not recruiting, Sponsor: Emma Guttman
The use of JAK inhibitors to block the signaling of numerous cytokines with a critical role in the pathogenesis of atopic dermatitis has revolutionized the treatment of this pathogenically complex, phenotypically heterogeneous skin disease. Recruiting --> Active, not recruiting
- | Dupixent (dupilumab) / Sanofi, Regeneron
Journal, Monotherapy: The relative efficacy of monotherapy with Janus kinase inhibitors, dupilumab and apremilast in adults with alopecia areata: Network meta-analyses of clinical trials. (Pubmed Central) - Jul 15, 2023
Recruiting --> Active, not recruiting Our results support the conduct of high-quality comparative trials to determine whether JAK inhibitors are more effective and safer than PDE4 inhibitors.
- | brepocitinib topical cream (PF-06700841 topical) / Priovant Therap, brepocitinib (PF-06700841) / Priovant Therap
Journal: Can brepocitinib be formulated into an effective topical therapy to treat mild-to-moderate chronic plaque psoriasis? (Pubmed Central) - Jul 10, 2023
Our results support the conduct of high-quality comparative trials to determine whether JAK inhibitors are more effective and safer than PDE4 inhibitors. No abstract available
- | brepocitinib (PF-06700841) / Priovant Therap
Enrollment closed: NEPTUNE: A Study of Brepocitinib in Adults With Active Non-Infectious Non-Anterior Uveitis (clinicaltrials.gov) - Jul 3, 2023
P2, N=24, Active, not recruiting, Sponsor: Priovant Therapeutics, Inc.
No abstract available Recruiting --> Active, not recruiting
- Adverse events in patients treated with Jak-inhibitors for alopecia areata: a systematic review () - Jul 3, 2023 - Abstract #WCD2023WCD_5751;
The AEs in AA patients receiving JAK-I are mostly mild and self-limited and predominantly consist of an increased risk of infections and laboratory abnormalities. No fatal outcomes or thromboembolism events have been reported
- || Clinical, Review, Journal: Recent developments for new investigational JAK inhibitors in psoriatic arthritis. (Pubmed Central) - Jun 14, 2023
Preliminary results from several RCTs have reported good and fast efficacy and an acceptable safety profile of investigational JAK inhibitors in PsA. Additional clinical trials and long-term outcome data on these agents are necessary for increasing available therapeutic options for PsA.
- || Review: Safety of Janus Kinase inhibitors in Patients with Alopecia Areata: A Systematic Review. (Pubmed Central) - May 22, 2023
The OR for upper respiratory tract infections varied from over 7-fold increased to comparable to placebo. The risk of serious adverse events was not increased.
- || brepocitinib (PF-06700841) / Priovant Therap
P2b data, Journal: Efficacy and Safety of Tyrosine Kinase 2/Janus Kinase 1 Inhibitor Brepocitinib for Active Psoriatic Arthritis: A Phase IIb Randomized Controlled Trial. (Pubmed Central) - May 17, 2023
Brepocitinib 30 and 60 mg QD were superior to placebo at reducing signs and symptoms of PsA. Brepocitinib was generally well tolerated throughout the 52-week study with a safety profile consistent with other brepocitinib clinical trials.
- || brepocitinib (PF-06700841) / Priovant Therap
P1 data, Journal: A phase 1 study to investigate the absorption, distribution, metabolism and excretion of brepocitinib in healthy males using a C-microdose approach. (Pubmed Central) - May 15, 2023
P1
The major route of elimination of brepocitinib was renal excretion as metabolites, whereas urinary elimination of unchanged brepocitinib was minor. NCT: NCT03770039.
- || Review, Journal: Systematic Review of Newer Agents for the Management of Alopecia Areata in Adults: Janus Kinase Inhibitors, Biologics and Phosphodiesterase-4 Inhibitors. (Pubmed Central) - Mar 20, 2023
In contrast, PDE-4 inhibitors (apremilast) and the biologics (dupilumab, secukinumab and aldesleukin) appear to have limited efficacy thus far. Results from ongoing and future long-term studies could shed light on the utility of the newer agents in altering the progression of AA.
- | brepocitinib (PF-06700841) / Priovant Therap
Journal: Hyperin promotes proliferation, migration, and invasion of HTR-8/SVneo trophoblast cells via activation of JAK1/STAT3 pathway in recurrent spontaneous abortions. (Pubmed Central) - Feb 7, 2023
In vivo experiments confirmed that hyperin reduces the embryo loss rate in recurrent spontaneous abortion (RSA) model mice. Furthermore, our study revealed that hyperin promoted the proliferation, migration, and invasion of HTR-8/SVneo cells via activation of the JAK1/STAT3 pathway, further improving pregnancy outcomes in RSA.
- ||| ritlecitinib (PF-06651600) / Pfizer, brepocitinib (PF-06700841) / Priovant Therap
Novel JAK inhibitors for UC Encouraging early data (Phase 2b) on oral ritlecitinib and brepocitinib for moderate-to-severely active UC https://t.co/Rfg2LxGD8u (Twitter) - Jan 13, 2023
- || ritlecitinib (PF-06651600) / Pfizer, brepocitinib (PF-06700841) / Priovant Therap
P2b data, Journal: Oral Ritlecitinib and Brepocitinib for Moderate-to-Severe Ulcerative Colitis: Results From a Randomized, Phase 2b Study. (Pubmed Central) - Jan 10, 2023
P2b
Furthermore, our study revealed that hyperin promoted the proliferation, migration, and invasion of HTR-8/SVneo cells via activation of the JAK1/STAT3 pathway, further improving pregnancy outcomes in RSA. Ritlecitinib and brepocitinib induction therapies were more effective than placebo for the treatment of moderate to severe active UC, with an acceptable short-term safety profile.
- || ropsacitinib (PF-06826647) / Priovant Therap, Sotyktu (deucravacitinib) / BMS, brepocitinib (PF-06700841) / Priovant Therap
Review, Journal: Novel Therapies in Plaque Psoriasis: A Review of Tyrosine Kinase 2 Inhibitors. (Pubmed Central) - Jan 3, 2023
Two phase 3 psoriasis trials demonstrated deucravacitinib was efficacious and not associated with safety concerns characteristic of Janus kinase inhibitors, hence the new class designation (TYK2 inhibitor) by health authorities in the USA and Japan. Allosteric tyrosine kinase 2 inhibitors represent a promising new class of molecules for the treatment of psoriasis and psoriatic arthritis, and longer-term trials will establish their place in therapy.
- | Journal: Clinical Implications of Targeting the JAK-STAT Pathway in Psoriatic Disease: Emphasis on the TYK2 Pathway. (Pubmed Central) - Dec 16, 2022
Other novel TYK2 allosteric inhibitors, NDI-034858 and ESK-001, are currently being investigated in adult patients with plaque psoriasis. This article reviews the details of the JAK-STAT pathway in psoriasis pathophysiology, the rationale for selective targeting of JAKs in the treatment of psoriasis, and provides clinical perspective on clinical trial data for JAK and TYK2 inhibitors.