Rilonacept

Generic Name: Rilonacept

Brand Names: Arcalyst, 炎朵

Drug Type: Biotech

Chemical Formula: -

CAS Number: 501081-76-1

Unique Ingredient Identifier: 8K80YB5GMG

Background: Rilonacept is a dimeric fusion protein consisting of portions of IL-1R and the IL-1R accessory protein linked to the Fc portion of immunoglobulin G1. Rilonacept functions as an interleukin 1 inhibitor and is used in the treatment of CAPS, also known as cryopyrin-associated periodic syndromes, including familial cold auto-inflammatory syndrome (FCAS) and Muck...

Indication: 用于治疗成人及12岁青少年罕见病周期性综合征(CAPS),即家族性寒冷型自身炎症综合征和穆-韦（Muckle-Wells）两氏综合征。

Associated Conditions: Cryopyrin-associated Periodic Syndromes (CAPS), Deficiency of the interleukin-1 receptor antagonist, Familial Cold Autoinflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS), Recurrent Pericarditis

Associated Therapies: -

Clinical Trials

Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis

Phase 3

Completed

Conditions: Recurrent Pericarditis

Interventions: Drug: Rilonacept
Drug: Placebo

First Posted Date: 2018-11-09

Last Posted Date: 2023-09-06

Lead Sponsor: Kiniksa Pharmaceuticals (UK), Ltd.

Target Recruit Count: 86

Registration Number: NCT03737110

Locations: 🇺🇸
Arthritis and Rheumatology of Georgia, Atlanta, Georgia, United States
🇺🇸
The Loretto Hospital, Chicago, Illinois, United States
🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States

and more 18 locations

Rilonacept for Treatment of Autoimmune Neurosensory Hearing Loss

Early Phase 1

Conditions: Autoimmune Neurosensory Hearing Loss (ANSHL)

Interventions: Drug: Rilonacept

First Posted Date: 2016-07-11

Last Posted Date: 2017-09-13

Lead Sponsor: Stanley Cohen

Target Recruit Count: 10

Registration Number: NCT02828033

Locations: 🇺🇸
Metroplex Clinical Research Center, Dallas, Texas, United States

Cold Contact Urticaria Treatment With Rilonacept

Phase 2

Completed

Conditions: Cold Contact Urticaria

Interventions: Drug: Placebo
Drug: Rilonacept

First Posted Date: 2014-06-24

Last Posted Date: 2018-07-17

Lead Sponsor: Charite University, Berlin, Germany

Target Recruit Count: 20

Registration Number: NCT02171416

Locations: 🇩🇪
University Berlin Charité ; Dermatology, Berlin, Germany
🇩🇪
Universitätsmedizin, Mainz, Germany

A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis

Phase 2

Completed

Conditions: Alcoholic Hepatitis

Interventions: Drug: Prednisolone
Drug: Mycophenolate mofetil
Drug: Rilonacept

First Posted Date: 2013-07-19

Last Posted Date: 2019-01-14

Lead Sponsor: Southern California Institute for Research and Education

Target Recruit Count: 4

Registration Number: NCT01903798

Locations: 🇺🇸
LAC USC Medical Center, Los Angeles, California, United States
🇺🇸
Harbor-UCLA Medical Center, Torrance, California, United States
🇺🇸
VA Long Beach Healthcare System, Long Beach, California, United States

Rilonacept (Arcalyst ®) in the Treatment of Subacromial Bursitis

Not Applicable

Completed

Conditions: Subacromial Bursitis

Interventions: Drug: Corticosteroid
Drug: Rilonacept

First Posted Date: 2013-04-12

Last Posted Date: 2014-08-04

Lead Sponsor: Keesler Air Force Base Medical Center

Target Recruit Count: 33

Registration Number: NCT01830699

Locations: 🇺🇸
Keesler Medical Center, Keesler AFB, Mississippi, United States

Rilonacept for Deficiency of the Interleukin-1 Receptor Antagonist (DIRA)

Phase 2

Completed

Conditions: DIRA

Interventions: Drug: Rilonacept

First Posted Date: 2013-02-28

Last Posted Date: 2017-10-16

Lead Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Target Recruit Count: 6

Registration Number: NCT01801449

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Interleukin-1 Trap to Treat Vascular Dysfunction in Chronic Kidney Disease (CKD)

Phase 4

Completed

Conditions: Renal Insufficiency, Chronic

Interventions: Drug: Rilonacept
Drug: Placebo

First Posted Date: 2012-08-13

Last Posted Date: 2016-09-12

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 42

Registration Number: NCT01663103

Locations: 🇺🇸
Vanderbilt University Medical Center, Nashville, Tennessee, United States
🇺🇸
University of Colorado Clinical and Translational Research Center (CTRC) Outpatient Clinic, Aurora, Colorado, United States

IL1-TRAP, Rilonacept, in Systemic Sclerosis

Phase 1

Completed

Conditions: Scleroderma
Diffuse Systemic Sclerosis
Systemic Sclerosis
Diffuse Scleroderma

Interventions: Other: Placebo
Drug: Rilonacept

First Posted Date: 2012-02-24

Last Posted Date: 2018-05-01

Lead Sponsor: Boston University

Target Recruit Count: 24

Registration Number: NCT01538719

Locations: 🇺🇸
Boston University Medical Center, Boston, Massachusetts, United States

Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares

Phase 3

Terminated

Conditions: Gout

Interventions: Drug: Placebo
Drug: Rilonacept
Drug: Allopurinol

First Posted Date: 2011-10-26

Last Posted Date: 2017-07-18

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 220

Registration Number: NCT01459796

Safety and Tolerability of Rilonacept in Muckle-Wells Syndrome (MWS) or Schnitzler Syndrome (SchS)

Phase 2

Completed

Conditions: Muckle-Wells Syndrome
Schnitzler Syndrome

Interventions: Drug: rilonacept

First Posted Date: 2010-01-11

Last Posted Date: 2012-05-31

Lead Sponsor: Charite University, Berlin, Germany

Target Recruit Count: 10

Registration Number: NCT01045772

Locations: 🇩🇪
Charité University Hospital, Berlin, Germany

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