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Canakinumab

Phase 2

Schnitzler Syndrome | Small molecule | Other |Pulmonx Corporation|Last Updated: Jul 17, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Canakinumab · 1 trial · 1 indication

Phase 2 1
NCT01390350Ilaris® Effects in Schnitzler Syndrome (ILESCH)Schnitzler Syndrome
COMPLETED20 Analytics
PHASE2COMPLETED
Ilaris® Effects in Schnitzler Syndrome (ILESCH)
Schnitzler SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

The effect of canakinumab on the clinical signs and symptoms of SchS measured by physician's global assessment
16 months

Proportion of patients with complete response (based on physician's global assessment on overall autoinflammatory disease activity) at day 7 in the canakinumab treated group as compared to the placebo group

Secondary Endpoints

The safety and tolerability of canakinumab in subjects with Schnitzler syndrome
16 months
The change in biomarkers of inflammation during the treatment period with canakinumab
16 months
Changes in patients' quality of life during the treatment period with canakinumab
16 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
CanakinumabEXPERIMENTAL -

Interventions

NameTypeDescription
CanakinumabDRUG150mg subcutaneous injections on day 0
PlaceboDRUG150mg subcutaneous injections on day 0
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Adults (18 years or older) * Informed consent signed and dated * Able to read, understand and willing to sign the informed consent form and abide with study procedures * SchS diagnosis based on diagnostic criteria defined in Appendix * Patients with symptomatic Schnitzler synd...

Countries:Germany
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Frequently asked questions about Canakinumab

What is Canakinumab used for in Schnitzler Syndrome?

Canakinumab is an investigational small molecule being studied for the treatment of Schnitzler Syndrome, a rare autoinflammatory condition. It is currently in Phase 2 clinical development. The drug has been evaluated in a completed clinical trial to assess its effects in patients with this syndrome.

What does Canakinumab target?

Canakinumab targets the interleukin-1 beta pathway, which plays a role in inflammation. By inhibiting this pathway, the drug aims to reduce the inflammatory symptoms associated with Schnitzler Syndrome. This mechanism is central to its potential therapeutic effect in the condition.

Who makes Canakinumab?

Canakinumab is being developed by Pulmonx Corporation, a company traded on the NASDAQ under the ticker symbol LUNG. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with Schnitzler Syndrome.

What phase is Canakinumab in?

Canakinumab is in Phase 2 clinical development for Schnitzler Syndrome. It is an investigational drug and has not yet been approved by regulatory authorities. A Phase 2 clinical trial has been completed to evaluate its effects in this patient population.

What clinical trials is Canakinumab in?

Canakinumab has been studied in a completed Phase 2 clinical trial with the identifier NCT01390350, titled "Ilaris® Effects in Schnitzler Syndrome (ILESCH)." This trial enrolled 20 participants in Germany and was a randomized, double-blind, placebo-controlled study.

Is Canakinumab the same as Ilaris?

Canakinumab is also known as Ilaris, as indicated by the clinical trial title "Ilaris® Effects in Schnitzler Syndrome." The drug is being investigated under this brand name in the context of the Phase 2 trial for Schnitzler Syndrome.