 |
Products |  |
Diseases | | Products |
|
Trials |  |
News |  |
| «12345678» |
- |||| Arcalyst (rilonacept) / Regeneron, Kiniksa
Proud to have been part of RHAPSODY at @VCUHealthHeart @VCU_CCTR Phase 3 Trial of Interleukin-1 Trap Rilonacept in Recurrent Pericarditis | NEJM https://t.co/hGgrroUSoC (Twitter) - Nov 16, 2020
- |||| Arcalyst (rilonacept) / Regeneron, Kiniksa
Clinical: 🚨🚨 Do not miss this highly anticipated #Rhapsodytrial at #AHA2020 🚨🚨 Our one and only @AllanLKleinMD1 is presenting results of IL1R blockade, using Rilonacept, in recurrent pericarditis. @PaulCremerMD @ImazioMassimo #cardiotwitter #MedTwitter #Clinicaltrial (Twitter) - Nov 16, 2020
- |||| Arcalyst (rilonacept) / Regeneron, Kiniksa
@Amgen interleukin-1 inhibitor rilonacept presents promising data for pericarditis episodes. #AHA20 (Twitter) - Nov 15, 2020
- Actemra IV (tocilizumab) / Roche, JW Pharma
[VIRTUAL] Late-Breaking Abstracts (Feed 8) - Nov 11, 2020 - Abstract #ACRARHP2020ACR_ARHP_3423;
Mavrilimumab was well tolerated, and no new safety signals were observed. Results with this novel treatment are encouraging for the management of GCA.
- ||||| mavrilimumab (KPL-301) / Kiniksa
Clinical, P2 data, Late-breaking abstract: Le mavrilimumab (anticorps anti-GMCSF-R): une piste prometteuse pour traiter la maladie de Horton. Un essai randomisé contrôlé sur 70 patients (phase 2) présenté aujourd'hui en Late-breaking abstract au congrès de #ACR20 .Cid et al. (LB06) (Twitter) - Nov 9, 2020
- ||| mavrilimumab (KPL-301) / Kiniksa
And anti-GMCSF mAbs....given signal with mavrilimumab. Exciting! (Twitter) - Nov 8, 2020
- mavrilimumab (KPL-301) / Kiniksa, Actemra IV (tocilizumab) / Roche, JW Pharma
[VIRTUAL] Mavrilimumab (anti GM-CSF Receptor α Monoclonal Antibody) Reduces Time to Flare and Increases Sustained Remission in a Phase 2 Trial of Patients with Giant Cell Arteritis (Feed 8) - Oct 24, 2020 - Abstract #ACRARHP2020ACR_ARHP_3126;
Mavrilimumab was well tolerated, and no new safety signals were observed. Results with this novel treatment are encouraging for the management of GCA.
- || Stelara (ustekinumab) / J&J
Retrospective data, Review, Journal: Systemic treatments for eczema: a network meta-analysis. (Pubmed Central) - Oct 23, 2020
Most studies were placebo-controlled and assessed only short-term efficacy of immunosuppressive agents. Further adequately powered head-to-head RCTs should evaluate comparative long-term efficacy and safety of available treatments for moderate to severe eczema.
- vixarelimab (KPL-716) / Kiniksa
[VIRTUAL] Vixarelimab reduced pruritus, improved nodules, and was well-tolerated in patients with Prurigo Nodularis in a Phase 2a, randomized, double-blind, placebo-controlled study () - Oct 20, 2020 - Abstract #EADV2020EADV_2982;
- mavrilimumab (KPL-301) / Kiniksa
[VIRTUAL] Mavrilimumab, a human monoclonal antibody targeting GM-CSFRα, inhibits polarization to myeloid-derived suppressor cells (MDSCs) that express PD-L1 and restores T-cell proliferation in vitro. () - Oct 14, 2020 - Abstract #SITC2020SITC_1502;
P2
Ethics Approval The study was approved by the Institute of Immunology and Immunotherapy, University of Birmingham, UK Ethics Board. Healthy volunteer human material was obtained from commercial sources and approved by Stemexpress Institutional Review Board (IRB).
- mavrilimumab (KPL-301) / Kiniksa
[VIRTUAL] Mavrilimumab, a human monoclonal antibody targeting GM-CSFRα, inhibits polarization to myeloid-derived suppressor cells (MDSCs) that express PD-L1 and restores T-cell proliferation in vitro. () - Oct 14, 2020 - Abstract #SITC2020SITC_767;
P2
Ethics Approval The study was approved by the Institute of Immunology and Immunotherapy, University of Birmingham, UK Ethics Board. Healthy volunteer human material was obtained from commercial sources and approved by Stemexpress Institutional Review Board (IRB).
- ||| Arcalyst (rilonacept) / Regeneron, Kiniksa
Full results to be presented at the American Heart Association 2020 - press release by Kiniksa announced Rilonacept significantly met primary endpoint. RHAPSODY: Rationale for and design of a pivotal Phase 3 trial to asses... https://t.co/fyZRC3iciz (Twitter) - Oct 10, 2020
- ||| Arcalyst (rilonacept) / Regeneron, Kiniksa
Clinical, P3 data, Journal: RHAPSODY: Rationale for and design of a pivotal Phase 3 trial to assess efficacy and safety of rilonacept, an interleukin-1α and interleukin-1β trap, in patients with recurrent pericarditis. (Pubmed Central) - Oct 9, 2020
P3
Safety evaluations include adverse event monitoring, physical examinations, and laboratory tests. The RHAPSODY trial will evaluate the efficacy and safety of rilonacept in the treatment of RP to improve outcomes and patient health-related quality of life.
- ||| mavrilimumab (KPL-301) / Kiniksa
Enrollment closed, Enrollment change: Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation (clinicaltrials.gov) - Oct 5, 2020
P2, N=30, Active, not recruiting, Sponsor: The Cleveland Clinic
The RHAPSODY trial will evaluate the efficacy and safety of rilonacept in the treatment of RP to improve outcomes and patient health-related quality of life. Recruiting --> Active, not recruiting | N=60 --> 30
- Arcalyst (rilonacept) / Regeneron, Kiniksa
[VIRTUAL] RHAPSODY: Rilonacept an IL-1α and IL-1β Trap Resolves Pericarditis Episodes and Reduces Risk of Recurrence in a Phase 3 Trial of Patients With Recurrent Pericarditis (Featured/Live) - Sep 17, 2020 - Abstract #AHA2020AHA_4306;
Rilonacept monotherapy reduced RP event risk by 96% vs placebo. Rilonacept may provide a targeted therapeutic option for patients with RP.
- Arcalyst (rilonacept) / Regeneron, Kiniksa
[VIRTUAL] Cardiac Magnetic Resonance Imaging in a Phase 2 Study of Rilonacept in Recurrent Pericarditis (OnDemand) - Sep 17, 2020 - Abstract #AHA2020AHA_2167;
Recurrence in one pt with incompletely resolved DHE after 6 months of rilonacept treatment could indicate that a longer treatment duration is warranted in patients with unresolved DHE. These preliminary results may inform future CMR-guided treatment studies in RP.
- ||| abiprubart (KPL-404) / Kiniksa
Enrollment open: Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of KPL-404 in Healthy Subjects (clinicaltrials.gov) - Sep 14, 2020
P1, N=60, Recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
These preliminary results may inform future CMR-guided treatment studies in RP. Active, not recruiting --> Recruiting
- || Kineret (anakinra) / SOBI, Affibody, Arcalyst (rilonacept) / Regeneron, Kiniksa, Ilaris (canakinumab) / Novartis
Clinical, Journal: Management of adult-onset Still's disease with interleukin-1 inhibitors: evidence- and consensus-based statements by a panel of Italian experts. (Pubmed Central) - Sep 10, 2020
Active, not recruiting --> Recruiting The Delphi method was used to develop recommendations that we hope will help clinicians in the management of patients with AOSD refractory to conventional therapies.
- ||| vixarelimab (RG6536) / Roche
Trial completion: A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases (clinicaltrials.gov) - Sep 2, 2020
P2, N=58, Completed, Sponsor: Kiniksa Pharmaceuticals, Ltd.
The Delphi method was used to develop recommendations that we hope will help clinicians in the management of patients with AOSD refractory to conventional therapies. Active, not recruiting --> Completed
- |||| vixarelimab (RG6536) / Roche
Trial completion date, Trial primary completion date: KPL-716-C201: Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis (clinicaltrials.gov) - Sep 2, 2020
P, N=49, Active, not recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
Active, not recruiting --> Completed Trial completion date: Oct 2020 --> Mar 2023 | Trial primary completion date: Jun 2020 --> Feb 2022
- || mavrilimumab (KPL-301) / Kiniksa
Clinical, Journal: GM-CSF blockade with mavrilimumab in severe COVID-19 pneumonia and systemic hyperinflammation: a single-centre, prospective cohort study. (Pubmed Central) - Aug 26, 2020
Confirmation of efficacy requires controlled testing. IRCCS San Raffaele Scientific Institute.
- |||| mavrilimumab (KPL-301) / Kiniksa
New P2 trial: Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflation (clinicaltrials.gov) - Aug 6, 2020
P2, N=60, Recruiting, Sponsor: Kristin Hudock
- ||| abiprubart (KPL-404) / Kiniksa
New P1 trial: Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of KPL-404 in Healthy Subjects (clinicaltrials.gov) - Aug 6, 2020
P1, N=60, Active, not recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
- || Review, Journal: Targeting GM-CSF in COVID-19 Pneumonia: Rationale and Strategies. (Pubmed Central) - Aug 6, 2020
Anti-GM-CSF monoclonal antibodies, TJ003234 and gimsilumab, will be tested in clinical trials in patients with COVID-19, while lenzilumab received FDA approval for compassionate use. These trials will help inform whether blunting the inflammatory signaling provided by the GM-CSF axis in COVID-19 is beneficial.
- |||||| mavrilimumab (KPL-301) / Kiniksa
Enrollment open: Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation (clinicaltrials.gov) - Jul 20, 2020
P2/3, N=573, Recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
These trials will help inform whether blunting the inflammatory signaling provided by the GM-CSF axis in COVID-19 is beneficial. Not yet recruiting --> Recruiting
- || Arcalyst (rilonacept) / Regeneron, Kiniksa
$KNSA FDA Orphan Designation for Rilonacept in Pericarditis (Twitter) - Jul 16, 2020
- |||| mavrilimumab (KPL-301) / Kiniksa
New P2 trial: Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation (clinicaltrials.gov) - Jul 8, 2020
P2, N=60, Recruiting, Sponsor: Virginia Commonwealth University
- || Clinical, Journal: Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis. (Pubmed Central) - Jul 8, 2020
Not yet recruiting --> Recruiting This SLR informed the task force regarding the evidence base of various therapeutic regimen for the development of the update of EULAR's RA management recommendation.
- ||| mavrilimumab (KPL-301) / Kiniksa, Kineret (anakinra) / SOBI, Affibody
This is beautiful: the most frequently studied #COVID19 drugs but I would add #anakinra #mavrilimumab #anticoagulants #antithrombotics plus techniques like early non invasive ventilation, #pronation Notably most failed. IMPORTANT: all these studies helped a lot disease knowledge (Twitter) - Jul 7, 2020
- || mavrilimumab (KPL-301) / Kiniksa
Rheumatologe: Mavrilimumab at the 2020 EULAR Online Meeting https://t.co/4p8if5Ko0T #GCA #EULAR2020 #COVIDー19 #Mavrilimumab (Twitter) - Jul 4, 2020
- |||||||||| mavrilimumab (KPL-301) / Kiniksa
New P2/3 trial: Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation (clinicaltrials.gov) - Jun 25, 2020
P2/3, N=573, Not yet recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
- || Arcalyst (rilonacept) / Regeneron, Kiniksa
Trial completion date: RHAPSODY: Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis (clinicaltrials.gov) - Jun 23, 2020
P3, N=86, Active, not recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
This SLR informed the task force regarding the evidence base of various therapeutic regimen for the development of the update of EULAR's RA management recommendation. Trial completion date: Jun 2021 --> Jun 2022
- ||| mavrilimumab (KPL-301) / Kiniksa
Mavrilimumab anti-GM-CSF in covid-19 in @TheLancetRheum (Twitter) - Jun 20, 2020
- |||| mavrilimumab (KPL-301) / Kiniksa
Clinical: GM-CSF blockade with mavrilimumab in severe COVID-19 pneumonia and systemic hyperinflammation: a single-centre, prospective cohort study https://t.co/C1O6W1v8GT (Twitter) - Jun 17, 2020
- mavrilimumab (KPL-301) / Kiniksa
[VIRTUAL] MAVRILIMUMAB IMPROVES OUTCOMES IN SEVERE COVID-19 PNEUMONIA AND SYSTEMIC HYPER-INFLAMMATION () - Jun 13, 2020 - Abstract #EULAR2020EULAR_4505;
Mavrilimumab was well-tolerated. Randomized controlled trials are warranted to confirm our findings.
- ||| Kineret (anakinra) / SOBI, Affibody, Arcalyst (rilonacept) / Regeneron, Kiniksa, Ilaris (canakinumab) / Novartis
Many lessons for #COVID19 stage 3 disease- marked therapeutic window of anakinra is particularly important over canakinumab and rilonacept- Over a dozen trials underway - all 3 small uncontrolled trials + but the data will be the data from RCTs @philipcrobinson @DrPujaMehta1 (Twitter) - Jun 3, 2020
- | Ilaris (canakinumab) / Novartis
Journal: Canakinumab for the treatment of hyperimmunoglobulin D syndrome. (Pubmed Central) - May 29, 2020
Some data suggest these patients may need higher dosage or shorter dosing interval than other AIDs, to achieve and maintain complete clinical and laboratory response. Reported adverse events were mild, most often non-complicated infections.
- Actemra IV (tocilizumab) / Roche, JW Pharma
[VIRTUAL] GM-CSFR PATHWAY IS IMPLICATED IN PATHOGENIC INFLAMMATORY MECHANISMS IN GIANT CELL ARTERITIS (Poster Tour) - May 22, 2020 - Abstract #EULAR2020EULAR_1585;
Expression of genes associated with inflammatory cells was suppressed by mavrilimumab in cultured GCA arteries. These data implicate the GM-CSF pathway in GCA pathophysiology and increase confidence in rationale for targeting the GM-CSF pathway in GCA.
- |||| mavrilimumab (KPL-301) / Kiniksa
New P2 trial: Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation (clinicaltrials.gov) - May 22, 2020
P2, N=60, Recruiting, Sponsor: The Cleveland Clinic
- | mavrilimumab (KPL-301) / Kiniksa
New P2 trial: Mavrilimumab in Severe COVID-19 Pneumonia and Hyper-inflammation (COMBAT-19) (clinicaltrials.gov) - May 21, 2020
P2, N=50, Not yet recruiting, Sponsor: Ospedale San Raffaele
- ||| vixarelimab (RG6536) / Roche
Enrollment closed, Enrollment change: A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases (clinicaltrials.gov) - Apr 27, 2020
P2, N=58, Active, not recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
These data implicate the GM-CSF pathway in GCA pathophysiology and increase confidence in rationale for targeting the GM-CSF pathway in GCA. Recruiting --> Active, not recruiting | N=130 --> 58
- ||||| vixarelimab (RG6536) / Roche
Enrollment closed, Enrollment change: KPL-716-C201: Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis (clinicaltrials.gov) - Apr 27, 2020
P, N=49, Active, not recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
Recruiting --> Active, not recruiting | N=130 --> 58 Recruiting --> Active, not recruiting | N=100 --> 49
- | Xeljanz (tofacitinib) / Pfizer, Marche Polytechnic University
Review, Journal: Targeting Granulocyte-Monocyte Colony-Stimulating Factor Signaling in Rheumatoid Arthritis: Future Prospects. (Pubmed Central) - Apr 23, 2020
Mainly because of this reason, nowadays the development program of most GM-CSF blockers for RA has been discontinued, with the exception of otilimab, which is under evaluation in two phase III RCTs with a head-to head non-inferiority design against tofacitinib...Phase II trials are ongoing with the aim of evaluating mavrilimumab for the treatment of giant cell arteritis, and namilumab for the treatment of spondyloarthritis...This review aims to describe in detail the available evidence on the GM-CSF blocking pathway in RA management, paving the way to a possible alternative treatment for RA patients. Novel insights regarding the potential use of GM-CSF blockers for alternative indications will be also addressed.
- | mavrilimumab (KPL-301) / Kiniksa
New P2 trial: Mavrilimumab to Reduce Progression of Acute Respiratory Failure in Patients With Severe COVID-19 Pneumonia and Systemic Hyper-inflammation (clinicaltrials.gov) - Apr 6, 2020
P2, N=10, Not yet recruiting, Sponsor: Virginia Commonwealth University
- ||| mavrilimumab (KPL-301) / Kiniksa, lenzilumab (KB003) / Humanigen
Clinical: Uncontrolled study but an interesting observation nonetheless. Wonder whether mavrilimumab or lenzilumab might also show some efficacy (Twitter) - Mar 19, 2020
- || mavrilimumab (KPL-301) / Kiniksa
Enrollment closed: KPL-301 for Subjects With Giant Cell Arteritis (clinicaltrials.gov) - Mar 13, 2020
P2, N=70, Active, not recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
Novel insights regarding the potential use of GM-CSF blockers for alternative indications will be also addressed. Recruiting --> Active, not recruiting
- ||||| Arcalyst (rilonacept) / Regeneron, Kiniksa
Enrollment closed, Enrollment change: RHAPSODY: Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis (clinicaltrials.gov) - Mar 13, 2020
P3, N=86, Active, not recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | N=56 --> 86
- Actemra IV (tocilizumab) / Roche, JW Pharma
Drug Reaction and High Fatality Lung Disease in Systemic Onset Juvenile Idiopathic Arthritis (sJIA) (Convention Center, 200 Level, Hall D) - Mar 1, 2020 - Abstract #AAAAI2020AAAAI_1375;
DReSS with lung involvement is a high fatality illness. Unrecognized DReSS with exposure to anti-IL-1/IL-6 may account for lung disease and poor outcome in some sJIA cases.
- Orencia (abatacept) / BMS, Actemra IV (tocilizumab) / Roche, JW Pharma, Enbrel (etanercept) / Pfizer, Amgen
DEVELOPMENT OF INFLAMMATORY BOWEL DISEASE (IBD) FOLLOWING THE USE OF BIOLOGIC TREATMENT FOR RHEUMATOLOGIC DISEASES: A REVIEW OF THE FOOD AND DRUG ADMINISTRATION ADVERSE EVENT REPORTS SYSTEM (FAERS) () - Jan 28, 2020 - Abstract #DDW2020DDW_3114;
This study shows that biologic therapy with medications such as etanercept, secukinumab, tocilizumab, ixekizumab and abatacept may unmask or stimulate the development of IBD in patients undergoing treatment for a variety of rheumatologic diseases. Further investigation of the mechanisms associated with the development of IBD in these patients is warranted.
- ||| tralokinumab (CAT 354) / Leo Pharma, AstraZeneca
Clinical, P3 data, Journal: Evaluation of Antibody Properties and Clinically Relevant Immunogenicity, Anaphylaxis, and Hypersensitivity Reactions in Two Phase III Trials of Tralokinumab in Severe, Uncontrolled Asthma. (Pubmed Central) - Jan 19, 2020
P3
In STRATOS 1 and 2, ADA incidence was low, no differences were found between tralokinumab-treated and placebo groups in reporting of hypersensitivity reactions, and there were no Sampson criteria-evaluated anaphylaxis events with tralokinumab treatment. Together, the results suggest that tralokinumab treatment would not increase the risk for severe hypersensitivity or anaphylactic reactions.