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Methoxsalen+ECP

Phase 2

Crohn's Disease | Small molecule | Gastrointestinal |Icon Plc|Last Updated: Oct 19, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

Methoxsalen+ECP · 1 trial · 1 indication

Phase 2 1
NCT00221026Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Crohn's DiseaseCrohn's Disease
COMPLETED25 Analytics
PHASE2COMPLETED
Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Crohn's Disease
Crohn's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Crohns Disease Activity Index
12 weeks

The CDAI is a questionaire giving the change of disease acitvity.This study wil llook or a decrease in CDAI score of at least 100.

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
drugEXPERIMENTALECP + Uvadex given for 12 weeks.

Interventions

NameTypeDescription
Methoxsalen +ECPDRUGECP + Uvadex given at weeks 1-12 weeks.
Extracorporeal PhotopheresisPROCEDUREECP given at weeks 1 through 12.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Signed and dated informed consent must be obtained prior to conducting any study procedure. * Patients must be greater than or equal to 18 years of age. * Patients must have a body weight greater than or equal to 40 kg (88 lb). * Patients must have had Crohn's disease for at l...

Countries:United StatesAustriaBelgiumGermany
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Frequently asked questions about Methoxsalen+ECP

What is Methoxsalen+ECP used for in Crohn's Disease?

Methoxsalen+ECP is an investigational small molecule being studied for the treatment of Crohn's Disease, a type of inflammatory bowel disease. It is delivered through extracorporeal photoimmune therapy, a procedure where blood is treated outside the body. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

How does Methoxsalen+ECP work?

Methoxsalen+ECP combines the small molecule methoxsalen with extracorporeal photopheresis (ECP). In this process, blood is collected, treated with methoxsalen, exposed to ultraviolet light, and then returned to the patient. This approach is designed to modulate the immune system's response, which is relevant in autoimmune conditions like Crohn's Disease.

Who is developing Methoxsalen+ECP?

Methoxsalen+ECP is being developed by Icon Plc, a biopharmaceutical company listed on the stock exchange under the ticker symbol ICLR. The company is conducting clinical research on this drug for the treatment of Crohn's Disease.

What phase is Methoxsalen+ECP in?

Methoxsalen+ECP is in Phase 2 clinical development for Crohn's Disease. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 2 trial has been completed, and the drug remains under investigation for safety and efficacy.

What clinical trials is Methoxsalen+ECP in?

Methoxsalen+ECP has been studied in one clinical trial with the identifier NCT00221026. This Phase 2 trial, titled 'Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Crohn's Disease,' enrolled 25 participants and was conducted in the United States, Austria, Belgium, and Germany. The trial has been completed.

Is Methoxsalen+ECP the same as UVADEX?

Methoxsalen+ECP is associated with the brand name UVADEX, as indicated in the clinical trial title. The trial evaluated extracorporeal photoimmune therapy using UVADEX, which contains methoxsalen. In this context, Methoxsalen+ECP and UVADEX refer to the same treatment approach for Crohn's Disease.