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MEDI-507

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment420

FDA Designations

No designations recorded

Clinical trial landscape

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 Psoriasis
NCT00540618420
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PHASE2COMPLETED
Study of MEDI-507 Administered by Intravenous Infusion to Adults With Plaque Psoriasis
Psoriasis
NCT00192452120
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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 used for?

MEDI-507 is an investigational small molecule being studied for graft versus host disease, kidney diseases, psoriasis, plaque psoriasis, and cancer. It has been evaluated in clinical trials for plaque psoriasis and graft-versus-host disease, including steroid-resistant acute graft-versus-host disease.

Who makes MEDI-507?

MEDI-507 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The drug is an investigational small molecule and is not approved for any indication.

What phase is MEDI-507 in?

MEDI-507 is in Phase 1 clinical development. Although one completed trial was a Phase 2 study in plaque psoriasis, the drug's current development stage is Phase 1, and it remains investigational.

What clinical trials is MEDI-507 in?

MEDI-507 has been studied in several completed trials, including NCT00540618 in plaque psoriasis, NCT00806208 in graft-versus-host disease, NCT00806728 in steroid-resistant acute graft-versus-host disease, and NCT00813618 in pediatric patients with graft versus host disease.

Is MEDI-507 the same as other names?

MEDI-507 is the primary name used in clinical trials. No alternative names have been reported for this drug.

What is the development status of MEDI-507?

MEDI-507 is an investigational drug that has completed multiple clinical trials, including a Phase 2 study in plaque psoriasis and several Phase 1 studies in graft-versus-host disease. It is not approved and remains in clinical development.