Phase 2a Study to Evaluate the Efficacy and Safety of MEDI9929 in Adults With Atopic Dermatitis (ALLEVIAD)

MedImmune

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Biological: Placebo; Biological: MEDI9929

Study type: Interventional

Funder types: Industry

Identifiers

NCT02525094

D5240C00001

Details and patient eligibility

About

To assess the efficacy and safety of MEDI9929 in adult subjects with Atopic Dermatitis

Full description

This is a Phase 2a, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of MEDI9929 administered subcutaneously to adult subjects with moderate to severe Atopic Dermatitis. Subjects will be randomized in a 1:1 fashion and will be stratified at screening. Approximately 100 subjects are planned to be randomized at approximately 35 sites in 6 countries

Enrollment: 113 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• AD meeting Hanifin and Rajka criteria
• Age 18-75 years inclusive at screening
• Atopic dermatitis that affects greater than/equal to 10% body surface area
• Moderate to severe AD
• Effective birth control in line with protocol details

Exclusion criteria

• Active dermatologic conditions which may confuse the diagnosis of Atopic Dermatitis
• Hepatitis B, C or HIV
• Pregnant or breastfeeding
• History of anaphylaxis following any biologic therapy
• History of clinically significant infections within 4 weeks prior to Visit 3
• Diagnosis of helminth parasitic infection within 6 months to screening
• History of Cancer except basal cell
• Receipt of any marketed or investigational biologic agent within 4 months to visit 3
• Any clinically relevant abnormal finding
• Major surgery within 8 weeks prior to Visit 1

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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113 participants in 2 patient groups, including a placebo group

MEDI9929 280 mg

Experimental group

Description:

Participants will receive 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10.

Treatment:

Biological: MEDI9929

Placebo

Placebo Comparator group

Description:

Participants will receive 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10.

Treatment:

Biological: Placebo