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MEDI-507

Phase 2

Plaque Psoriasis | Small molecule | Dermatology |AstraZeneca PLC|Trials Updated: Dec 23, 2008

MEDI-507 development status

Highest phase Phase 2
Registered trials 9 across 2 sponsors since Mar 2005

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials6
Total Enrollment614

FDA Designations

No designations recorded

MEDI-507 clinical trials

MEDI-507 · 6 trials · 6 indications

Phase 2 2Phase 1 4
NCT00540618A Phase II Study of MEDI-507, Administered by Injection to Adults With PsoriasisPlaque Psoriasis
COMPLETED420 Analytics
NCT00192452Study of MEDI-507 Administered by Intravenous Infusion to Adults With Plaque PsoriasisPsoriasis
COMPLETED120 Analytics
PHASE2COMPLETED
A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis
Plaque PsoriasisUnlock trial analytics
PHASE2COMPLETED
Study of MEDI-507 Administered by Intravenous Infusion to Adults With Plaque Psoriasis
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Biological activity will be assessed primarily by the Psoriasis Activity and Severity Index (PASI)
Days 14, 28, 42, 56, 70, 91, 107, and 167
Analyses of categorical data will be performed and analysis of continuous data will be performed using a one-way analysis of variance (ANOVA) with traetment group as a factor.
Safety assessment of escalating dose levels of MEDI-507 in pediatric stell scell (SCT) and bone marrow (BMT) allograft recipients who have at least Grade II Graft-versus-Host Disease (GvHD).
Through Study Day 44
Safety; first infusion of study drug
Through Study Day 44
Safety was assessed by the direct observation of patients, medical history, and clinical laboratory evaluation to determine the incidence of patients experiencing AEs.
Day 0-60
To evaluate the clinical safety of MEDI-507. Each adverse event will be reported by severity grade, relationship to study drug, organ system, and need for medical intervention.
Day 33

Secondary Endpoints

Observe adverse and serious adverse events
Day 107 and 167
Percentage of subjects with at least 75% improvement and those with at least 50% improvement will be compared.
Evaluate the serum concentrations and pharmacokinetics (PK) of MEDI 507 and pharmacodynamic effects of MEDI-507 on the absolute lymphocyte count and dynamics of lymphocyte phenotypes.
Through Study Day 364
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORMEDI-507
2PLACEBO_COMPARATOR -
3ACTIVE_COMPARATORMEDI-507
4ACTIVE_COMPARATORMEDI-507
5PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
MEDI-507DRUGCompare in a placebo controlled manner, the disease activity of three dosing regimens of MEDI-507 (Monoclonal Antibody)
PlaceboOTHER -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites43

Inclusion Criteria: * Plaque psoriasis involving at least 10% of body surface area * Age 18 through 65 years at the time of the first dose of study drug * Both males and females are eligible. However, sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have u...

Countries:United StatesCanada
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Frequently asked questions about MEDI-507

What is MEDI-507?

MEDI-507 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN). It has been studied in clinical trials for graft versus host disease, kidney diseases, cancer, plaque psoriasis, and psoriasis. It is in Phase 1 development and is not described as approved for any indication.

What is MEDI-507 used for?

MEDI-507 has been studied for graft versus host disease, including steroid-resistant acute GvHD and at least Grade II GvHD, as well as for prevention of acute renal allograft rejection in kidney disease. Trials have also listed cancer, plaque psoriasis, and psoriasis among the conditions studied.

Who makes MEDI-507?

MEDI-507 is developed by AstraZeneca PLC, which trades under the ticker AZN. The company is the sponsor associated with the clinical trial program for this asset.

What phase is MEDI-507 in?

MEDI-507 is in Phase 1 clinical development. Its trials are listed as Phase 1 studies, and the program includes completed trials only, with no active trials currently listed. It is investigational and has not been described as FDA approved.

What clinical trials is MEDI-507 in?

MEDI-507 has been evaluated in completed Phase 1 trials including NCT00813618 in pediatric patients with graft versus host disease, NCT00807794 in kidney disease for prevention of acute renal allograft rejection, NCT00806728 in steroid-resistant acute GvHD, and NCT00806208 in at least Grade II GvHD.

How many patients have been enrolled in MEDI-507 trials?

The MEDI-507 clinical program lists a total enrollment of 420 patients across its trials. Individual completed Phase 1 studies ranged from 10 patients in the pediatric GvHD trial to 34 patients in the dose-escalation GvHD trial, with trials conducted in the United States.