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CureXcell

Phase 3

Lower Extremity Chronic Ulcers in Diabetics | Monoclonal antibody | Other |Icon Plc|Last Updated: Dec 7, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindSHAM_CONTROLLEDDMC
Total Trials1
Total Enrollment285

FDA Designations

No designations recorded

Clinical trial landscape

CureXcell · 1 trial · 1 indication

Phase 3 1
NCT01421966Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With DiabetesLower Extremity Chronic Ulcers in Diabetics
COMPLETED285 Analytics
PHASE3COMPLETED
Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes
Lower Extremity Chronic Ulcers in Diabetics
NCT01421966285
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Study Endpoints

Primary Endpoints

Proportion of patients with complete healing/closure of their target ulcer at any time during the 16-week double-blind core treatment period with sustained complete closure for 4 additional weeks of follow-up.
up to 20 weeks

Secondary Endpoints

Time to complete closure of the Target Ulcer during the core double blind treatment phase with sustained complete closure for 4 additional weeks of follow-up.
up to 20 weeks
Proportion of patients with at least 50% closure of target ulcer during the 16-week core treatment period.
16 weeks
Proportion of patients whose Target Ulcer completely closed during the core double blind treatment phase and remained closed at the FU12 follow-up visit.
up to 28 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CureXcell®EXPERIMENTAL -
Sham injectionSHAM_COMPARATOR -

Interventions

NameTypeDescription
CureXcell®BIOLOGICALCureXcell® injection will be administered about every 4 weeks for up to 4 treatments, or until until ulcer closure, whichever occurs first.
Sham injectionBIOLOGICALThe sham injections will be made by pressing on the ulcer with a needle connected to an empty syringe, at each cm of the ulcer bed
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: 1. Males or females at least 18 years of age with diabetes type 1 or type 2; 2. Patients with HbA1c ≤ 12%; 3. Patients with at least one lower extremity (on or below the malleolus (ankle bone)), at least full-thickness ulcer (penetrating through the whole layer of the skin), whi...

Countries:United StatesCanadaIsrael
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Frequently asked questions about CureXcell

What is CureXcell used for?

CureXcell is an investigational monoclonal antibody being studied for the treatment of lower extremity chronic ulcers in adults with diabetes. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.

What does CureXcell target?

CureXcell is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being evaluated for its potential to treat chronic ulcers in the lower extremities of diabetic patients.

Who is developing CureXcell?

CureXcell is being developed by Icon Plc, a company listed on the stock exchange under the ticker ICLR. The drug is currently in Phase 3 clinical trials for the treatment of lower extremity chronic ulcers in diabetic patients.

What phase is CureXcell in?

CureXcell is in Phase 3 clinical development. It is an investigational drug and has not yet received regulatory approval. A Phase 3 trial has been completed, but the drug remains under investigation for its intended use.

What clinical trials is CureXcell in?

CureXcell has one completed Phase 3 trial, identified as NCT01421966, which evaluated the drug in 285 adults with lower extremity chronic ulcers and diabetes. The trial was randomized, double-blind, and sham-controlled, and was conducted in the United States, Canada, and Israel.