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- ||||| vixarelimab (RG6536) / Roche
Trial completion date, Trial termination, Trial primary completion date: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC) (clinicaltrials.gov) - Jun 27, 2025
P2, N=79, Terminated, Sponsor: Genentech, Inc.
Trial completion date: Feb 2028 --> Jun 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Sep 2026 --> Jun 2025; Based on a futility analysis, which suggested that the Moonglow study was unlikely to meet its primary endpoint.
- vixarelimab (RG6536) / Roche
Divergent Oncostatin M receptor-driven pathways across fibrotic and inflammatory conditions (PS-8; Board Number: 20) - Jun 11, 2025 - Abstract #ERS2025ERS_1230;
However, while OSMR+ stroma was observed across indications, ILD and IBD displayed marked differences in abundance (Fig1B) and profibrotic/proinflammatory phenotype (Fig1C) of these cells, suggesting tissue- and disease- specific responses to OSMR blockade. Vixarelimab, an anti-human OSMR antagonist, is currently in Ph2 trials for IPF, SSc-ILD and UC.
- || Review, Journal, IO biomarker: Emerging Therapies in the Treatment of Prurigo Nodularis: Biological Therapy and Systematic Review of Literature. (Pubmed Central) - May 15, 2025
Targeted therapies are revolutionizing PN treatment. Integrating clinical efficacy, immunologic endotyping, and real-world data will be pivotal to optimizing therapeutic strategies, enhancing outcomes, and personalizing care in prurigo nodularis.
- || Review, Journal: New and Emerging Biologics and Jak Inhibitors for the Treatment of Prurigo Nodularis: A Narrative Review. (Pubmed Central) - Apr 27, 2025
Small molecules such as JAK inhibitors (upadacitinib, povorcitinib) also show potential by modulating inflammatory pathways...Emerging biologics and small molecules represent a transformative approach for PN management, offering targeted therapies that address underlying immunological and neurological mechanisms. Ongoing research and long-term studies are crucial to optimizing treatment strategies and improving patient outcomes.
- ||| vixarelimab (RG6536) / Roche
Enrollment change: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC) (clinicaltrials.gov) - Apr 26, 2025
P2, N=79, Active, not recruiting, Sponsor: Genentech, Inc.
Ongoing research and long-term studies are crucial to optimizing treatment strategies and improving patient outcomes. N=210 --> 79
- ||| vixarelimab (RG6536) / Roche
Enrollment closed: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC) (clinicaltrials.gov) - Apr 7, 2025
P2, N=210, Active, not recruiting, Sponsor: Genentech, Inc.
N=210 --> 79 Recruiting --> Active, not recruiting
- || vixarelimab (RG6536) / Roche
Enrollment open: A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants With Moderate to Severe Active Ulcerative Colitis (clinicaltrials.gov) - Mar 17, 2025
P1/2, N=24, Recruiting, Sponsor: Genentech, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- vixarelimab (RG6536) / Roche
Discovery of Divergent Oncostatin M Receptor-driven Pathways Across Fibrotic and Inflammatory Conditions (Area L, Hall F (North Building, Exhibition Level), Moscone Center; Poster Board # P1398) - Mar 16, 2025 - Abstract #ATS2025ATS_9323;
Vixarelimab, an anti-human OSMR antagonist, is currently being tested in the clinic for SSc-ILD, IPF and UC. Acknowledgements: The authors would like to acknowledge the Mark S. Wilson lab for their contributions to this research.
- || vixarelimab (RG6536) / Roche
Trial completion date, Trial primary completion date: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC) (clinicaltrials.gov) - Mar 11, 2025
P2, N=210, Recruiting, Sponsor: Genentech, Inc.
Acknowledgements: The authors would like to acknowledge the Mark S. Wilson lab for their contributions to this research. Trial completion date: Feb 2027 --> Feb 2028 | Trial primary completion date: May 2026 --> Sep 2026
- vixarelimab (RG6536) / Roche
EVALUATING THE PHARMACODYNAMIC (PD) EFFECTS OF VIXARELIMAB IN PATIENTS WITH ULCERATIVE COLITIS (UC): DESIGN AND RATIONALE FOR A PHASE 1C STUDY (Halls C-E, Lower Level - SDCC) - Mar 8, 2025 - Abstract #DDW2025DDW_7645;
P2
Conclusion The evaluation of inflammatory fibroblasts in patients with UC through integration of OSMR? occupancy assay and snRNA-seq enables assessment of mechanistic insights for first-in-class therapeutic targeting of the inflammatory fibroblast-myeloid cell axis by vixarelimab in UC.
- vixarelimab (RG6536) / Roche
THERAPEUTIC BLOCKADE OF OSM/IL31R SIGNALING IN DSS-INDUCED COLITIS ACCELERATES WOUND HEALING BY REDUCING INFLAMMATORY FIBROBLAST ACTIVATION AND NEUTROPHIL RECRUITMENT (Halls C-E, Lower Level - SDCC) - Mar 8, 2025 - Abstract #DDW2025DDW_7049;
P2
Histology, gene expression, and flow cytometry were utilized to understand which model best recapitulated the biology associated with non-response. We found that OSM was strongly induced in models that cause epithelial damage, such as DSS-induced colitis and the pinch biopsy model, but not in infectious models such as the Hh + anti-IL10 or C. rodentium model.
- vixarelimab (RG6536) / Roche
Baseline Characteristics of Idiopathic Pulmonary Fibrosis and Systemic-sclerosis-associated Interstitial Lung Disease Patients Enrolled in the Moonscape Study of Vixarelimab (Area M, Hall F (North Building, Exhibition Level), Moscone Center; Poster Board # P1616) - Feb 24, 2025 - Abstract #ATS2025ATS_2000;
P2
CONCLUSIONS Moonscape will provide evidence for the efficacy and safety of vixarelimab in patients with IPF and SSc-ILD. Interim patient baseline data indicates enrollment of patients with clinical and demographic characteristics that are reflective of IPF and SSc-ILD real-world populations.
- vixarelimab (RG6536) / Roche
Phase classification: A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants With Moderate to Severe Active Ulcerative Colitis (clinicaltrials.gov) - Dec 26, 2024
P1/2, N=24, Not yet recruiting, Sponsor: Genentech, Inc.
Interim patient baseline data indicates enrollment of patients with clinical and demographic characteristics that are reflective of IPF and SSc-ILD real-world populations. Phase classification: P1 --> P1/2
- vixarelimab (RG6536) / Roche
Design and rationale for the phase 1c study evaluating the pharmacodynamic (PD) effects of vixarelimab in patients with Ulcerative Colitis (UC) (Poster exhibition) - Dec 21, 2024 - Abstract #ECCOIBD2025ECCO_IBD_1124;
P2
Conclusion Integrating OSMR? occupancy assay and snRNA-seq informs on assessment of inflammatory fibroblasts in patients with UC, enabling mechanistic insights for first-in-class therapeutic targeting of the inflammatory fibroblast-myeloid cell axis by vixarelimab in UC.
- || vixarelimab (RG6536) / Roche
Trial primary completion date: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC) (clinicaltrials.gov) - Dec 18, 2024
P2, N=210, Recruiting, Sponsor: Genentech, Inc.
occupancy assay and snRNA-seq informs on assessment of inflammatory fibroblasts in patients with UC, enabling mechanistic insights for first-in-class therapeutic targeting of the inflammatory fibroblast-myeloid cell axis by vixarelimab in UC. Trial primary completion date: Sep 2026 --> May 2026
- || Review, Journal: Therapies for Chronic Spontaneous Urticaria: Present and Future Developments. (Pubmed Central) - Nov 27, 2024
Additionally, molecules targeting the Mas-related G protein-coupled receptor X2 (MRGPRX2), and those inhibiting the tyrosine kinase receptor Kit, such as barzolvolimab, show promise in clinical studies...Further research is essential to better elucidate the pathophysiology of CSU and optimize treatment protocols to achieve long-term benefits in managing this condition. Altogether, the future of CSU treatments that target pathogenetic mechanisms seems promising.
- || vixarelimab (RG6536) / Roche
New P1 trial, New P1/2 trial: A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants With Moderate to Severe Active Ulcerative Colitis (clinicaltrials.gov) - Nov 18, 2024
P1, N=24, Not yet recruiting, Sponsor: Genentech, Inc.
- vixarelimab (RG6536) / Roche, Nemluvio (nemolizumab-ilto) / Galderma
The role of IL-31 and its inhibitors in treating pruritus (Poster Area) - Aug 5, 2024 - Abstract #EADV2024EADV_2046;
As of now inhibition of IL-31 by targeting the IL-31/IL31RA/OSMR ? axis suggests the improvement in pruritus, sleep quality, and overall, quality of life of patients suffering from pruritic disorders and appears to be a promising treatment option for such illnesses.
- | Journal: Chronic Prurigo. (Pubmed Central) - Jun 10, 2024
It also highlights other agents currently being studied in Phase II and Phase III clinical, randomized, placebo-controlled trials. These include biologics such as nemolizumab (anti-IL-31-RA-mAb), vixarelimab/KPL-716 (anti-Oncostatin-M receptor ?-mAb), and barzolvolimab/CDX-0159 (anti-KIT-mAb), as well as Janus kinase inhibitors such as povorcitinib/INCB054707 and abrocitinib, and opioid modulators such as nalbuphine.
- etrolizumab (RG7413) / Roche, vixarelimab (RG6536) / Roche, Humira (adalimumab) / AbbVie
ELEVATED OSM/OSMR EXPRESSION IN INFLAMED MUCOSAL TISSUE REFLECTS AN INFLAMMATORY CASCADE MEDIATED BY NEUTROPHIL:STROMAL INTERACTIONS ASSOCIATED WITH RESIDUAL DISEASE IN TREATMENT-REFRACTORY UC PATIENTS (102AB - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_8104;
P2
Blockade of OSMR to decrease pro-inflammatory mediators of inflammatory fibroblasts and dampen the inflammatory cycle in UC is a viable strategy for achieving benefits in clinical disease. Vixarelimab, an OSMR-targeted monoclonal antibody that blocks OSM/OSMR signaling, is currently in Ph2 clinical development for UC (NCT06137183).
- Dupixent (dupilumab) / Sanofi, Regeneron, vixarelimab (RG6536) / Roche, Mitchga (nemolizumab) / Roche, Maruho, Galderma
Biologic and Oral Small Molecule Treatment for Prurigo Nodularis: An Evidence-Based Review () - Feb 20, 2024 - Abstract #AAD2024AAD_2230;
These results indicate dupilumab and tofacitinib may be efficacious and safe agents for clearance of PN with nemolizumab and vixarelimab being additional options for reduction of pruritus. Larger-scale studies are warranted.
- || vixarelimab (RG6536) / Roche, Mitchga (nemolizumab) / Roche, Maruho, Galderma
Review, Journal: A systematic review of interleukin-31 inhibitors in the treatment of prurigo nodularis. (Pubmed Central) - Feb 9, 2024
IL-31 inhibitors suggest distinct advantages in improving pruritus, sleep quality, and overall quality of life in subjects with moderate-to-severe PN. Further clinical studies are recommended to compare the effectiveness of these biologics to other therapeutic choices.
- |||| vixarelimab (RG6536) / Roche
Enrollment open: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC) (clinicaltrials.gov) - Jan 16, 2024
P2, N=210, Recruiting, Sponsor: Genentech, Inc.
Further clinical studies are recommended to compare the effectiveness of these biologics to other therapeutic choices. Not yet recruiting --> Recruiting
- | vixarelimab (RG6536) / Roche
Phase classification: KPL-716-C201: Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis (clinicaltrials.gov) - Dec 14, 2023
P2, N=190, Completed, Sponsor: Kiniksa Pharmaceuticals, Ltd.
Not yet recruiting --> Recruiting Phase classification: P --> P2
- ||||| vixarelimab (RG6536) / Roche
New P2 trial: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC) (clinicaltrials.gov) - Nov 18, 2023
P2, N=210, Not yet recruiting, Sponsor: Genentech, Inc.
- ||| vixarelimab (RG6536) / Roche
Trial completion: KPL-716-C201: Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis (clinicaltrials.gov) - Sep 26, 2023
P2a/b, N=190, Completed, Sponsor: Kiniksa Pharmaceuticals, Ltd.
Phase classification: P --> P2 Active, not recruiting --> Completed
- || Review, Journal: Chronic Prurigo Including Prurigo Nodularis: New Insights and Treatments. (Pubmed Central) - Sep 17, 2023
In the last past 15 years, several milestones have been reached regarding the disease understanding of CPG such as first transcriptomic analysis, first terminology, first guideline, and first therapy approval in 2022, which contributed to improved medical care of affected patients. The broad range of identified targets, current case observations and initiated trials offers the possibility of more drug approvals in the near future.
- Dupixent (dupilumab) / Sanofi, Regeneron, vixarelimab (RG6536) / Roche, Mitchga (nemolizumab) / Roche, Maruho, Galderma
How to treat different severity stages of chronic nodular prurigo in 2023: what are the guidelines recommending and what is new? (Level 3 - Room 327) - Apr 24, 2023 - Abstract #WCD2023WCD_2949;
Recently dupilumab has recently received approval for the treatment of moderate to severe CNPG...For example, pruritus intensity on the NRS decreased by over 60% and pruriginous lesions improved in 78% of patients treated with nemolizumab, a humanized monoclonal antibody against IL-31 receptor-A. As another monoclonal antibody, vixarelimab blocks the action of IL-31 and OSM at the OSM-receptor-
- ||||| vixarelimab (RG6536) / Roche
New P2 trial: A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary Fibrosis and in Participants With Systemic Sclerosis-Associated Interstitial Lung Disease (clinicaltrials.gov) - Mar 27, 2023
P2, N=290, Recruiting, Sponsor: Genentech, Inc.
- || vixarelimab (RG6536) / Roche
Enrollment closed: KPL-716-C201: Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis (clinicaltrials.gov) - Sep 28, 2022
P2a/b, N=190, Active, not recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
As another monoclonal antibody, vixarelimab blocks the action of IL-31 and OSM at the OSM-receptor- Recruiting --> Active, not recruiting
- || 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) - May 2, 2022
P2a/b, N=230, Recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
Recruiting --> Active, not recruiting Trial completion date: Mar 2023 --> Jul 2023 | Trial primary completion date: Feb 2022 --> Nov 2022
- | vixarelimab (KPL-716) / Kiniksa
Journal: Oncostatin M Induction of Monocyte Chemoattractant Protein 1 is Inhibited by Anti-oncostatin M Receptor Beta Monoclonal Antibody KPL-716. (Pubmed Central) - Jun 24, 2021
KPL-716, not anti-IL-31Rα, significantly attenuated MCP-1 response to OSM and OSM + IL-4 in human epidermal keratinocytes and human dermal fibroblasts. OSM, not leukemia inhibitory factor or IL-31, synergized with IL-4 and IL-13 in human epidermal keratinocytes and human dermal fibroblasts, suggesting therapeutic potential of KPL-716 in inflammatory dermatologic diseases distinct from IL-31 inhibition.
- vixarelimab (KPL-716) / Kiniksa
[VIRTUAL] Vixarelimab, an Anti-osmr-beta Fully Human Monoclonal Antibody, Inhibits Osm-induced Activation of Intestinal Fibroblasts in Tnf-refractory Ulcerative Colitis () - May 24, 2021 - Abstract #FOCIS2021FOCIS_311;
We confirmed in the biopsies used for these explant cultures as well as in dissociated cells from ulcerative colitis patients, an enhanced level of fibroblasts in disease compared with healthy controls. Together, these data suggest that vixarelimab may represent an approach for treating TNF-refractory ulcerative colitis patients with high levels of circulating OSM, by inhibiting OSM-mediated fibroblast activation.
- |||| vixarelimab (RG6536) / Roche
Enrollment open, Enrollment change: KPL-716-C201: Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis (clinicaltrials.gov) - Dec 21, 2020
P2a/b, N=230, Recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
Together, these data suggest that vixarelimab may represent an approach for treating TNF-refractory ulcerative colitis patients with high levels of circulating OSM, by inhibiting OSM-mediated fibroblast activation. Active, not recruiting --> Recruiting | N=49 --> 230
- || 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;
- |||| 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.
Further adequately powered head-to-head RCTs should evaluate comparative long-term efficacy and safety of available treatments for moderate to severe eczema. Trial completion date: Oct 2020 --> Mar 2023 | Trial primary completion date: Jun 2020 --> Feb 2022
- ||| 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.
Trial completion date: Oct 2020 --> Mar 2023 | Trial primary completion date: Jun 2020 --> Feb 2022 Active, not recruiting --> Completed
- ||| 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.
Active, not recruiting --> Completed 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
- ||| vixarelimab (RG6536) / Roche
Enrollment open: A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases (clinicaltrials.gov) - Jun 4, 2019
P2, N=130, Recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
Recruiting --> Active, not recruiting | N=100 --> 49 Not yet recruiting --> Recruiting
- |||||| vixarelimab (RG6536) / Roche
Enrollment open: KPL-716-C201: Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis (clinicaltrials.gov) - Mar 20, 2019
P, N=100, Recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||| vixarelimab (RG6536) / Roche
New P2 trial: A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases (clinicaltrials.gov) - Mar 1, 2019
P2, N=130, Not yet recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
- ||||| vixarelimab (RG6536) / Roche
Trial initiation date: KPL-716-C201: Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis (clinicaltrials.gov) - Feb 22, 2019
P, N=100, Not yet recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.
Not yet recruiting --> Recruiting Initiation date: Jun 2019 --> Mar 2019
- |||||| vixarelimab (RG6536) / Roche
New trial: KPL-716-C201: Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis (clinicaltrials.gov) - Jan 24, 2019
P, N=100, Not yet recruiting, Sponsor: Kiniksa Pharmaceuticals, Ltd.