A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 (Sonelokimab) in Subjects With Moderate to Severe Psoriasis
NCT ID: NCT03384745
Last Updated: 2021-08-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
313 participants
INTERVENTIONAL
2018-07-31
2020-03-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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M1095 (Sonelokimab) 30mg
M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.
M1095 (Sonelokimab)
M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
M1095 (Sonelokimab) 60mg
M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.
M1095 (Sonelokimab)
M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
M1095 (Sonelokimab) 120mg - regimen 1
M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks.
M1095 (Sonelokimab)
M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
M1095 (Sonelokimab) 120mg - regimen 2
M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.
M1095 (Sonelokimab)
M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
Placebo / M1095 (Sonelokimab) 120mg
Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120mg, given at Week 12, 14, 16, and every four weeks.
M1095 (Sonelokimab)
M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
Placebo
Placebo contains no active drug.
Secukinumab
Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks.
Secukinumab
Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
Interventions
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M1095 (Sonelokimab)
M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
Placebo
Placebo contains no active drug.
Secukinumab
Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Moderate to severe plaque-type psoriasis for at least 6 months.
3. Subject is a candidate for systemic biologic therapy.
4. Subject has IGA ≥3, involved body surface area (BSA) ≥10%, and PASI ≥12 at screening and at baseline.
5. Subject is able to comply with the study procedures.
6. Subject must provide informed consent.
Exclusion Criteria
2. Other medical conditions, including planned surgery or active infection / history of infection, as defined in the study protocol. Subjects will be screened for tuberculosis and hepatitis B / hepatitis C.
3. Laboratory abnormalities at screening, as defined in the study protocol.
4. Prior use of systemic or topical treatments for psoriasis, as defined in the study protocol.
5. Prior use of any compound targeting IL-17, more than two biologic therapies, ustekinumab within 6 months, or TNF targeting therapies within 12 weeks.
6. History of suicidal thoughts within 12 months.
18 Years
75 Years
ALL
No
Sponsors
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Avillion LLP
INDUSTRY
Bond Avillion 2 Development LP
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. Kim Papp
Role: PRINCIPAL_INVESTIGATOR
Probity Medical Research Inc
Locations
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Investigative Site
Birmingham, Alabama, United States
Investigative Site
San Diego, California, United States
Investigative Site
DeLand, Florida, United States
Investigative Site
Sandy Springs, Georgia, United States
Investigative Site
St Louis, Missouri, United States
Investigative Site
Albuquerque, New Mexico, United States
Investigative Site
New York, New York, United States
Investigative Site
Bexley, Ohio, United States
Investigative Site
Dallas, Texas, United States
Investigative Site
Houston, Texas, United States
Investigative Site
San Antonio, Texas, United States
Investigative Site
Dupnitsa, , Bulgaria
Investigative Site
Sofia, , Bulgaria
Investigative Site
Varna, , Bulgaria
Investigative Site
Edmonton, Alberta, Canada
Investigative Site
Surrey, British Columbia, Canada
Investigative Site
Surrey, British Columbia, Canada
Investigative Site
Markham, Ontario, Canada
Investigative Site
North Bay, Ontario, Canada
Investigative Site
Oakville, Ontario, Canada
Investigative Site
Ottawa, Ontario, Canada
Investigative Site
Richmond Hill, Ontario, Canada
Investigative Site
Waterloo, Ontario, Canada
Investigative Site
Windsor, Ontario, Canada
Investigative Site
Québec, Quebec, Canada
Investigative Site
Brno, , Czechia
Investigative Site
Náchod, , Czechia
Investigative Site
Nový Jičín, , Czechia
Investigative Site
Ostrava, , Czechia
Investigative Site
Ostrava, , Czechia
Investigative Site
Pardubice, , Czechia
Investigative Site
Prague, , Czechia
Investigative Site
Uherské Hradiště, , Czechia
Investigative Site
Augsburg, , Germany
Investigative Site
Berlin, , Germany
Investigative Site
Bochum, , Germany
Investigative Site
Darmstadt, , Germany
Investigative Site
Frankfurt am Main, , Germany
Investigative Site
Friedrichshafen, , Germany
Investigative Site
Hamburg, , Germany
Investigative Site
Kiel, , Germany
Investigative Site
Mahlow, , Germany
Investigative Site
Mainz, , Germany
Investigative Site
Osnabrück, , Germany
Investigative Site
Quedlinburg, , Germany
Investigative Site
Schwerin, , Germany
Investigative Site
Budapest, , Hungary
Investigative Site
Budapest, , Hungary
Investigative Site
Kecskemét, , Hungary
Investigative Site
Orosháza, , Hungary
Investigative Site
Szeged, , Hungary
Investigative Site
Szolnok, , Hungary
Investigative Site
Katowice, , Poland
Investigative Site
Lublin, , Poland
Investigative Site
Poznan, , Poland
Investigative Site
Siedlce, , Poland
Investigative Site
Skierniewice, , Poland
Investigative Site
Warsaw, , Poland
Investigative Site
Warsaw, , Poland
Investigative Site
Warsaw, , Poland
Countries
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References
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Papp KA, Weinberg MA, Morris A, Reich K. IL17A/F nanobody sonelokimab in patients with plaque psoriasis: a multicentre, randomised, placebo-controlled, phase 2b study. Lancet. 2021 Apr 24;397(10284):1564-1575. doi: 10.1016/S0140-6736(21)00440-2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AV002
Identifier Type: -
Identifier Source: org_study_id
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