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anti-IL-20

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

anti-IL-20 · 2 trials · 3 indications

Phase 1 2
NCT01038674Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid ArthritisInflammation
COMPLETED16 Analytics
NCT00818064Safety and Tolerability of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid ArthritisInflammation
COMPLETED32 Analytics
PHASE1COMPLETED
Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid Arthritis
InflammationUnlock trial analytics
PHASE1COMPLETED
Safety and Tolerability of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid Arthritis
InflammationUnlock trial analytics

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 to 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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Frequently asked questions about anti-IL-20

What is anti-IL-20 used for?

Anti-IL-20 is an investigational small molecule being developed for inflammation, including rheumatoid arthritis. It is in Phase 1 clinical development and has been studied in healthy volunteers and patients with rheumatoid arthritis to evaluate safety and tolerability.

Who makes anti-IL-20?

Anti-IL-20 is being developed by Novo Nordisk A/S, a biopharmaceutical company traded on the New York Stock Exchange under the ticker NVO.

What phase is anti-IL-20 in?

Anti-IL-20 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both focused on safety and tolerability in healthy volunteers and patients with rheumatoid arthritis.

What clinical trials is anti-IL-20 in?

Anti-IL-20 has been studied in two completed Phase 1 trials. NCT00818064 evaluated safety and tolerability in healthy volunteers and patients with rheumatoid arthritis in the Netherlands. NCT01038674 evaluated safety and tolerability in patients with rheumatoid arthritis in Belgium and Poland.

Is anti-IL-20 a small molecule?

Yes, anti-IL-20 is a small molecule therapeutic. It is being developed as an immunology treatment for inflammatory conditions, including rheumatoid arthritis.