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anti-IL-20

Phase 1

Inflammation | Small molecule | Immunology |Novo Nordisk A/S|Last Updated: Feb 9, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials2
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01038674Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid ArthritisPHASE1 COMPLETED 16 — — Feb 1, 2010Dec 1, 2010Feb 9, 20172 Belgium, Poland
NCT00818064Safety and Tolerability of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid ArthritisPHASE1 COMPLETED 32 — — Dec 1, 2008Jan 1, 2010Feb 9, 20171 Netherlands
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Study Endpoints
Primary Endpoints
Adverse events
0 - 21 weeks after dosing
Adverse events, including injection site tolerability
during treatment
Secondary Endpoints
Terminal serum half-life
0 - 21 weeks after dosing
Maximum observed serum concentration (Cmax)
6 - 10 weeks after dosing
Change in ACR20, ACR50 and ACR70
0-21 hours after dosing
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Anti-IL-20EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
A, HVEXPERIMENTALDose cohort 1 (3 subjects active, 1 placebo)
B, HVEXPERIMENTALDose cohort 2 (3 subjects active, 1 placebo)
C, HVEXPERIMENTALDose cohort 3 (3 subjects active, 1 placebo)
D, HVEXPERIMENTALDose cohort 4 (3 subjects active, 1 placebo)
E, HVEXPERIMENTALDose cohort 5 (3 subjects active, 1 placebo)
A, RAEXPERIMENTALDose cohort 1 (3 subjects active, 1 placebo)
B, RAEXPERIMENTALDose cohort 2 (3 subjects active, 1 placebo)
C, RAEXPERIMENTALDose cohort 3 (3 subjects active, 1 placebo)
Interventions
NameTypeDescription
anti-IL-20DRUGAnti-IL-20 injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.
placeboDRUGPlacebo injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Informed consent obtained before any trial-related activities * A diagnosis of rheumatoid arthritis made at least 3 months prior to screening * Active rheumatoid arthritis, characterised by a DAS28 equal or above 3.2 * Methotrexate treatment (stable dose, equal or below 25 mg/...

Countries:BelgiumPolandNetherlands
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