[Translation] A Phase III, multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of PF-06823859 in subjects with active idiopathic inflammatory myopathies, including subjects with active dermatomyositis or polymyositis

主要：在活动性DM和PM成人受试者（≥18岁）中评价PF-06823859与安慰剂相比在改善肌肉症状方面的疗效。关键次要：在活动性DM和PM成人受试者（≥18岁）中评价PF-06823859与安慰剂相比在改善皮肤（队列1）及肌肉（队列1和2）体征和症状以及患者健康状况方面的疗效。其他次要：在指定时间点评价PF-06823859与安慰剂相比在改善TIS各类别、TISCSM各方面和皮肤状态方面的疗效。安全性次要：评价PF-06823859与安慰剂相比的安全性以及对DM或PM受试者中自身抗体形成的影响。探索性：在指定时间点评价PF-06823859与安慰剂相比在改善TIS各类别、TIS CSM各方面，皮肤状态，改善体力活动方面的疗效，在改善患者报告结局方面的经时疗效，激素减量和挽救治疗规避效应;通过皮肤照相评价PF-06823859改善皮肤状态的疗效;评价PF-06823859在改善肌肉耐力的疗效;分析PF-062823859的PK特征;确定靶点结合情况;确定IFN活性;估计PF-06823859对PROQoL和健康的经时影响;评价PF-06823859的免疫原性。

[Translation]

Primary: To evaluate the efficacy of PF-06823859 compared with placebo in improving muscle symptoms in adult subjects (≥18 years old) with active DM and PM. Key Secondary: To evaluate the efficacy of PF-06823859 compared with placebo in improving skin (cohort 1) and muscle (cohorts 1 and 2) signs and symptoms and patient health status in adult subjects (≥18 years old) with active DM and PM. Other Secondary: To evaluate the efficacy of PF-06823859 compared with placebo in improving TIS categories, various aspects of TISCSM and skin status at designated time points. Secondary Safety: To evaluate the safety of PF-06823859 compared with placebo and the effect on autoantibody formation in subjects with DM or PM. Exploratory: Evaluate the efficacy of PF-06823859 compared with placebo in improving various categories of TIS, various aspects of TIS CSM, skin status, physical activity, the temporal efficacy in improving patient-reported outcomes, hormone reduction and rescue therapy avoidance effects at designated time points; evaluate the efficacy of PF-06823859 in improving skin status by skin photography; evaluate the efficacy of PF-06823859 in improving muscle endurance; analyze the PK characteristics of PF-062823859; determine target binding; determine IFN activity; estimate the temporal effects of PF-06823859 on PROQoL and health; and evaluate the immunogenicity of PF-06823859.

Start Date10 Nov 2023

Sponsor / Collaborator

Pfizer Inc.

[+2]

NCT05879718 / RecruitingPhase 2

A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE CLINICAL EFFECT, PHARMACODYNAMIC, PHARMACOKINETIC AND SAFETY PROFILE OF PF-06823859 IN ADULT PARTICIPANTS WITH ACTIVE CLE OR SLE WITH CUTANEOUS MANIFESTATIONS

The purpose of this study is to learn about the effects, safety and how PF-06823859 is processed in adults with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) showing some skin symptoms.
This study is seeking for participants who:
* are adults of 18 years of age or older.
* are confirmed to have CLE or SLE with involvement of the skin.
* have a Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score of at least 8.
About 48 participants will be selected to receive active study medicine (PF-06823859) or placebo (an infusion without drug). About 32 are grouped to receive the active study medicine and 16 are to receive placebo. They will be receiving the treatments by intravenous infusion (injected directly into the veins).
At week 16 all participants receiving the active study drug since day 1 and participants who have received placebo since day 1 and are not responding clinically will receive active study medication. Patients who have received placebo since Day 1 and who have had a clinical response will continue to receive placebo till week 40. All participants will have last follow-up visit at Week 60.
The study will compare participants receiving PF-06823859 to participants who receive placebo. This will help us see if PF-06823859 is safe and effective to treat CLE or SLE with skin symptoms and improve participant's CLASI-A score. Participants will take part in this study for about 65 weeks. This includes up to a 5-week selection period, a 12-week Q4Wk treatment period, a 36-week Q8Wk treatment period, and a 12-week follow-up period.

Start Date07 Jul 2023

Sponsor / Collaborator

Pfizer Inc.

NCT05895786 / RecruitingPhase 3

A PHASE 3, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06823859 IN PARTICIPANTS WITH ACTIVE IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH ACTIVE DERMATOMYOSITIS OR POLYMYOSITIS)

The purpose of the study is to understand how the study medicine PF-06823859 works in people with idiopathic inflammatory myopathies (DM and PM). These disorders cause inflammation that weakens the muscles that are important for movement and may also cause skin rash in people with DM.
This study is seeking participants who:
* Are 18 years of age or older or minimum legal adult age as defined per local regulation, whichever is greater
* Have active DM or active PM.
* Are receiving a stable dose of 1 corticosteroid taken by mouth and/or 1 traditional immunosuppressant.
* Note: Corticosteroids and immunosuppressants are medicines that help reduce inflammation and may signal to the immune system not to attack the body.
Dermatomyositis (DM) is a rare disease that causes muscle inflammation that results in muscle weakness and low muscle stamina. Patients with DM have a characteristic skin rash. Polymyositis (PM) is a rare disease that involves mainly muscle inflammation resulting in muscle weakness, that can sometimes be painful. Patients with DM and PM may have trouble going up the steps, walking or getting to a standing position.
Some of the participants will receive the study medicine (PF-06823859) and some will receive placebo (which is similar to study medicine but contains no medicine in it).
The study medicine or placebo will be given as an intravenous (IV) infusion (directly into the veins), which takes about1 hour; every 4 weeks from Day 1 to Week 48 of the study. Both PF-06823859 and placebo and will be given at the study site.
The study will compare the experiences of people receiving study medication to those of the people who do not. This will help to see if PF-06823859 is safe and effective.
Participants will take part in this study for about 13 months. During this time, participants will have 15 study visits. These visits will be performed at the study site.

Start Date20 May 2023

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with Dazukibart

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Literatures (Medical) associated with Dazukibart

01 Mar 2021·Clinical Pharmacology in Drug Development

Safety, Tolerability, and Pharmacokinetics of PF‐06823859, an Anti–Interferon β Monoclonal Antibody: A Randomized, Phase I, Single‐ and Multiple‐Ascending‐Dose Study

Article

Author: Salganik, Mikhail ; Rath, Natalie ; Cox, Lori ; Johnson, Kristen ; Messing, Dean ; Neelakantan, Srividya ; Oemar, Barry ; Page, Karen ; Pelletier, Kathleen ; Tarabar, Sanela ; Berman, Gabe

AbstractThis double‐blind, randomized, placebo‐controlled, dose‐ascending, first‐in‐human study (NCT02766621) assessed the safety, tolerability, and pharmacokinetics (PK) of PF‐06823859, an anti–interferon β monoclonal antibody. Healthy subjects were randomized to single ascending doses (SADs) of intravenous PF‐06823859 30, 100, 300, 900, or 2000 mg or placebo; to multiple ascending doses (MADs) of subcutaneous PF‐06823859 100 or 300 mg or placebo (once every 2 weeks for a total of 3 doses); or to MAD of intravenous PF‐06823859 600 mg or placebo (once every 3 weeks or once every 4 weeks for a total of 2 doses). The incidence, severity, and causal relationship of adverse events (AEs) were assessed, along with immunogenicity and PK. In total, 62 subjects were randomized to treatment (SAD, n = 35; MAD, n = 27). There were 76 treatment‐emergent all‐causality AEs in the SAD (PF‐06823859: n = 25; placebo: n = 4) and MAD (PF‐06823859: n = 40; placebo: n = 7) cohorts. In the SAD cohorts, all treatment‐emergent all‐causality AEs were mild in severity; 4 AEs of moderate severity were identified in the MAD cohorts. No dose‐limiting AEs, serious AEs, treatment‐related discontinuations, dose reductions, or deaths occurred. PF‐06823859 exposure increased dose‐proportionally, with half‐life values ranging between 23 and 35 days. The estimated subcutaneous bioavailability was 43% to 44%. Immunogenicity incidence rates were low (antidrug antibodies, 12.5%; neutralizing antibodies, 2.1%). No immunogenically related clinical responses of concern were observed. In conclusion, PF‐06823859 demonstrated an acceptable safety, tolerability, and PK profile that supports clinical development for treating disorders associated with increased interferon β levels, such as dermatomyositis or systemic lupus erythematosus.

News (Medical) associated with Dazukibart

18 Jul 2023

·www.prnewswire.com

Inflammatory Myositis Market to Accelerate Substantially at a CAGR of 11.7% by 2032, Predicts DelveInsight

The inflammatory myositis market is anticipated to surge owing to improvements in diagnosis over the globe and thus the surge in treatment options. In addition, the expected launch of emerging therapies by leading companies such as CSL Behring, Immunoforge Co. Ltd., Argenx, Janssen, Abcuro, Inc., and others will also propel the inflammatory myositis market size. LAS VEGAS, July 18, 2023 /PRNewswire/ -- DelveInsight's Inflammatory Myositis Market Insights report includes a comprehensive understanding of current treatment practices, inflammatory myositis emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Key Takeaways from the Inflammatory Myositis Market Report As per DelveInsight analysis, the inflammatory myositis market size in the 7MM was approximately USD 575 million in 2022. According to the assessment done by DelveInsight, the estimated total diagnosed prevalent inflammatory myositis cases in the 7MM were approximately 184K in 2022. Leading inflammatory myositis companies such as CSL Behring, Immunoforge Co. Ltd., Argenx, Janssen, Abcuro, Inc., Horizon Therapeutics, Merck KGaA, Galapagos NV, Priovant Therapeutics, Roivant, Alexion Pharmaceuticals, Pfizer, Kezar Life Sciences, and others are developing novel inflammatory myositis drugs that can be available in the inflammatory myositis market in the coming years. The promising inflammatory myositis therapies in the pipeline include Hizentra, PF 1801, Efgartigimod, Nipocalimab, ABC008, Daxdilimab (HZN-7734/MEDI7734/VIB7734), Enpatoran (M5049), GLPG3667, Brepocitinib (PF-06700841), ULTOMIRIS (Ravulizumab), PF-06823859 (Dazukibart), Zetomipzomib (KZR-616), and others. Discover which therapies are expected to grab the major inflammatory myositis market share @ Inflammatory Myositis Market Report Inflammatory Myositis Overview Inflammatory myositis, often known as myositis, is a rare autoimmune condition characterized by muscular inflammation. Polymyositis, dermatomyositis, inclusion body myositis, and necrotizing autoimmune myopathy are all examples of inflammatory myositis. The exact cause of inflammatory myositis is unknown, although it is thought to be related to an aberrant immunological response in which the body's immune system destroys its own muscle tissue by mistake. Muscle weakness, muscle soreness, difficulty swallowing, weariness, and, in certain cases, skin rashes are the most common symptoms of inflammatory myositis. The severity of the inflammatory myositis symptoms varies and may worsen over time. Dermatomyositis is characterized by skin rashes, which frequently include the face and upper torso. A medical history, physical examination, blood tests, electromyography (EMG), muscle biopsy, and imaging techniques such as MRI are commonly used to identify inflammatory myositis. Inflammatory Myositis Epidemiology Segmentation DelveInsight estimates that there were approximately 184K diagnosed prevalent cases of inflammatory myositis in the 7MM in 2022. According to DelveInsight estimates, assessments indicate that within the age groups of 0–17 years, 18–44 years, 45–64 years, and 65 years and above, a greater prevalence of diagnosed cases of inflammatory myositis was observed among individuals aged 45–64 years with 77.6K cases in 2022 in the 7MM. The inflammatory myositis market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Inflammatory Myositis Diagnosed Prevalent Cases Inflammatory Myositis Type-specific Cases Inflammatory Myositis Age-specific Diagnosed Prevalent Cases Inflammatory Myositis Gender-specific Diagnosed Prevalent Cases Inflammatory Myositis Treatment Market Inflammatory myositis is usually treated with a mix of pharmaceutical treatments and supportive measures. The primary goals of inflammatory myositis treatment are to reduce inflammation, manage symptoms, preserve muscle function, and avoid potential consequences. Currently, therapeutic techniques for inflammatory myositis include a combination of immunosuppressive medications such as corticosteroids and disease-modifying anti-rheumatic drugs (DMARDs) such as immunosuppressive agents. Biologic drugs, physical therapy, and supportive measures are also used. Biologic drugs such as rituximab or tocilizumab, which precisely targets immune system components to decrease inflammation, may be used in patients with severe or resistant inflammatory myositis.In more severe or resistant cases, drugs such as cyclophosphamide or cyclosporine may be administered to dampen the immune response and reduce inflammation. If corticosteroids, immunosuppressive drugs, and IVIG fail to relieve symptoms, IV cyclophosphamide can be used as a last-resort treatment. Prograf capsules (generic name: tacrolimus) are an immunosuppressive medicine extensively used in the treatment of a variety of medical diseases, including myositis, in Japan. The US Food and Drug Administration (FDA) has approved OCTAGAM 10% (Immune Globulin Intravenous [Human]) for the treatment of adult dermatomyositis, a rare immune-mediated inflammatory disease. The US FDA has approved ACTHAR Gel (repository corticotropin injection) for use in individuals with two subtypes of idiopathic inflammatory myopathies (IIMs), dermatomyositis (DM) and polymyositis (PM). ACTHARGel is a naturally occurring blend of adrenocorticotropic hormone analogues and pituitary peptides. To know more about inflammatory myositis treatment, visit @ Inflammatory Myositis Treatment Drugs Key Inflammatory Myositis Therapies and Companies Hizentra: CSL Behring PF 1801: Immunoforge Co. Ltd. Efgartigimod: Argenx Nipocalimab: Janssen ABC008: Abcuro, Inc. Daxdilimab (HZN-7734/MEDI7734/VIB7734): Horizon Therapeutics Enpatoran (M5049): Merck KGaA GLPG3667: Galapagos NV Brepocitinib (PF-06700841): Priovant Therapeutics/Roivant ULTOMIRIS (Ravulizumab): Alexion Pharmaceuticals PF-06823859 (Dazukibart): Pfizer Zetomipzomib (KZR-616): Kezar Life Sciences Learn more about the FDA-approved drugs for inflammatory myositis @ Drugs for Inflammatory Myositis Treatment Inflammatory Myositis Market Dynamics The inflammatory myositis market is expected to change in the coming years. The therapeutic landscape is abundant in terms of assessing the efficacy, safety, and tolerability of innovative medications in patients with inflammatory myositis and its different forms. Rising data on the general prevalence of inflammatory myositis and its subtypes is predicted to dramatically increase the patient pool. Moreover, the inflammatory myositis companies and academics are working to assess challenges and seek opportunities that could influence inflammatory myositis R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition. Inflammatory myositis companies are involved in developing inflammatory myositis therapies. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the inflammatory myositis market in the 7MM. However, certain factors may affect the growth of the inflammatory myositis market. The growing pipeline is gloomy, with a scarcity of effective late-stage drugs. The existing therapeutic options are linked with concerning side effects such as renal toxicity, nausea, osteoporosis, pulmonary toxicity, and others. Moreover, the inflammatory myositis market growth may be offset by unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the inflammatory myositis market growth. Scope of the Inflammatory Myositis Market Report Therapeutic Assessment: Inflammatory Myositis current marketed and emerging therapies Inflammatory Myositis Market Dynamics: Attribute Analysis of Emerging Inflammatory Myositis Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's Views, Analyst's Views, Inflammatory Myositis Market Access and Reimbursement Discover more about inflammatory myositis drugs in development @ Inflammatory Myositis Clinical Trials Table of Contents Related Reports Myositis Pipeline Myositis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myositis companies, including GlaxoSmithKline, Corbus Pharmaceuticals, Abcuro, Inc., Orphazyme, Bristol-Myers Squibb, Kezar Life Sciences, Inc., Horizon Therapeutics, Viela Bio, Paean Biotechnology Inc., Alexion Pharmaceuticals, Janssen Biotech, CSL Behring, Pfizer, Roche, among others. Inclusion Body Myositis Epidemiology Forecast Inclusion Body Myositis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted inclusion body myositis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Inclusion Body Myositis Market Inclusion Body Myositis Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key inclusion body myositis companies, including Acceleron Pharma Inc, KPI Therapeutics Inc, Milo Biotechnology LLC, Nobelpharma Co Ltd, Orphazyme ApS, Ultragenyx Pharmaceutical Inc, among others. Inclusion Body Myositis Pipeline Inclusion Body Myositis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key inclusion body myositis companies, including Acceleron Pharma Inc, KPI Therapeutics Inc, Milo Biotechnology LLC, Nobelpharma Co Ltd, Orphazyme ApS, Ultragenyx Pharmaceutical Inc, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

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Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Inflammatory Myopathies	Phase 3	JP	Pfizer Inc.	20 May 2023
Idiopathic Inflammatory Myopathies	Phase 3	DE	Pfizer Inc.	20 May 2023
Idiopathic Inflammatory Myopathies	Phase 3	HU	Pfizer Inc.	20 May 2023
Idiopathic Inflammatory Myopathies	Phase 3	IL	Pfizer Inc.	20 May 2023
Idiopathic Inflammatory Myopathies	Phase 3	AR	Pfizer Inc.	20 May 2023
Idiopathic Inflammatory Myopathies	Phase 3	ES	Pfizer Inc.	20 May 2023
Idiopathic Inflammatory Myopathies	Phase 3	CN	Pfizer Inc.	20 May 2023
Idiopathic Inflammatory Myopathies	Phase 3	TW	Pfizer Inc.	20 May 2023
Idiopathic Inflammatory Myopathies	Phase 3	GB	Pfizer Inc.	20 May 2023
Idiopathic Inflammatory Myopathies	Phase 3	KR	Pfizer Inc.	20 May 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05037409 (CTgov)	Phase 1	-	13	Placebo	(dhjjlfibpi) = zthihjsbhd yhhjbnyxpx (syuvudqvyb, rrtkbdwmbl - whkfqysxvw) View more	-	15 Dec 2023
NCT03181893 (EADV2023)	Phase 2	Dermatomyositis IFN β	72	PF-06823859 150 mg	ajnhizhvgh(wtdedrcwhc) = lkgwlurpzb ajmahjmzef (yarsmomsja ) View more	-	11 Oct 2023
				PF-06823859 600 mg	ajnhizhvgh(wtdedrcwhc) = vjjluazmiu ajmahjmzef (yarsmomsja ) View more
NCT02766621 (Pubmed) Manual	Phase 1	-	62	PF 06823859	(yccvliiyag) = No deaths occurred. bevbbkwmux (mtaqpbkddq ) View more	Positive	01 Mar 2021
				Placebo

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