Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: 20 mg ASB17061; Drug: 10 mg ASB17061; Drug: Placebo; Drug: 5 mg ASB17061

Study type: Interventional

Funder types: Industry

Identifiers

NCT01756898

ASBI 704

Details and patient eligibility

About

The purpose of this research study is to gather scientific information about the effectiveness of the study drug, ASB17061 capsules, when compared to placebo in adult subjects with atopic dermatitis.

Enrollment: 370 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult subjects ages 18 to 65 years
• A diagnosis of atopic dermatitis (AD)
• An Investigator's Global Assessment (IGA) score of 2 or higher and AD affecting at least 5% of total Body Surface Area (BSA)
• Other than active AD, in good health with no medical condition that may jeopardize the safety of the subject or impact the validity of the study results
• Subjects must be practicing acceptable birth control methods

Exclusion criteria

• Taking systemic immunosuppressive therapy within 3 months prior to screening or systemic (cortico) steroid therapy within 4 weeks prior to screening
• Use of phototherapy or tanning beds within 6 weeks of screening
• Presence of a clinically significant disorder involving gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition, which will jeopardize the safety of the subject or impact the validity of the study results
• Female subjects who are pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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370 participants in 4 patient groups, including a placebo group

Low dose ASB17061

Experimental group

Description:

Oral administration of low dose ASB17061 taken once daily for 28 consecutive days.

Treatment:

Drug: 5 mg ASB17061

Middle dose ASB17061

Experimental group

Description:

Oral administration of middle dose ASB17061 taken once daily for 28 consecutive days.

Treatment:

Drug: 10 mg ASB17061

High dose ASB17061

Experimental group

Description:

Oral administration of high dose ASB17061 taken once daily for 28 consecutive days.

Treatment:

Drug: 20 mg ASB17061

Placebo

Placebo Comparator group

Description:

Oral administration of placebo taken once daily for 28 consecutive days.

Treatment:

Drug: Placebo