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

NCT01756898 | Completed Phase 2 Results

• 1 other identifier: ASBI 704
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 40

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; eczema

Outcome Measures

Primary Outcomes (2)

• Number of Investigator's Global Assessment (IGA) Responders at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis

  Participants with an IGA score of 0 or 1 were considered IGA responders. The investigator provided an overall assessment of disease severity using the IGA, which consists of a 6-point scale from a minimum of 0 and a maximum of 6. Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).

  Baseline up to 29 days after initial dose.

• Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis

  Participants with an IGA score of 0 or 1 were considered IGA responders. The investigator provided an overall assessment of disease severity using the IGA which consists of a 6-point scale from the minimum of 0 to a maximum of 6. Higher scores indicate increasing severity.. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease) and an overall assessment of the disease severity of the entire body using the Eczema Area and Severity Index (EASI). A composite index, the EASI has a minimum score of 0 (clear) and a maximum score of 72 (very severe); A value less than 15 indicates less severe, and 15 or greater indicates more severe. Lichenification was evaluated on a scale of 0 (none) as the minimum to 3 (severe) as the maximum, and the score of each body region was summed (0 to 12). A percent body surface area (BSA) involved less than 15 is less severe and 15 or greater more severe.

  Baseline up to 29 days after initial dose.

Secondary Outcomes (9)

• Mean Change From Baseline in Eczema Area and Severity Index Score (EASI) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29

  Baseline up to 29 days after initial dose.

• Mean Change From Baseline in The Percentage of Body Surface Area (BSA) Involved Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29

  Baseline up to 29 days after initial dose.

• Mean Change From Baseline in Pruritus Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29

  Baseline up to 29 days after initial dose.

• Mean Change From Baseline in Insomnia Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29

  Baseline up to 29 days after initial dose.

• Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis

  Baseline (Day 1 Predose) up to Day 8, Day 15, and Day 22 at 0 to 2.5 hours, 2.5 to 5 hours, 5 to 10 hours, up to Day 29 at 24-32 hours postdose.

Study Arms (4)

Low dose ASB17061

EXPERIMENTAL

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

Drug: 5 mg ASB17061

Middle dose ASB17061

EXPERIMENTAL

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

Drug: 10 mg ASB17061

High dose ASB17061

EXPERIMENTAL

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

Drug: 20 mg ASB17061

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

5 mg ASB17061 DRUG

Oral administration of 5 mg ASB17061 taken once daily for 28 consecutive days.

Low dose ASB17061

Placebo DRUG

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

Placebo

10 mg ASB17061 DRUG

Oral administration of 10 mg ASB17061 taken once daily for 28 consecutive days.

Middle dose ASB17061

20 mg ASB17061 DRUG

Oral administration of 20 mg ASB17061 taken once daily for 28 consecutive days.

High dose ASB17061

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (40)

Unknown Facility

Birmingham, Alabama, 35233, United States

Location

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Phoenix, Arizona, 85018, United States

Location

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Rogers, Arkansas, 72758, United States

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Encino, California, 91436, United States

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Fremont, California, 94538, United States

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San Diego, California, 92122, United States

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Temecula, California, 92592, United States

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Denver, Colorado, 80220, United States

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Miami, Florida, 33144, United States

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Miami, Florida, 33175, United States

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Miramar, Florida, 33027, United States

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Saint Augustine, Florida, 32086, United States

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South Tampa, Florida, 33609, United States

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Tampa, Florida, 33609, United States

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Tampa, Florida, 33613, United States

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Savannah, Georgia, 31405, United States

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Boise, Idaho, 83704, United States

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Overland Park, Kansas, 66215, United States

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Crowley, Louisiana, 70526, United States

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Bay City, Michigan, 48706, United States

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Clinton Township, Michigan, 48038, United States

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Fort Gratiot, Michigan, 48059, United States

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Berlin, New Jersey, 08009, United States

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Verona, New Jersey, 07044, United States

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Stony Brook, New York, 11790, United States

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Raleigh, North Carolina, 27612, United States

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Sylvania, Ohio, 43560, United States

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Lake Oswego, Oregon, 97035, United States

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Portland, Oregon, 97239, United States

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Johnston, Rhode Island, 02919, United States

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Arlington, Texas, 76011, United States

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College Station, Texas, 77845, United States

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Pflugerville, Texas, 78660, United States

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San Antonio, Texas, 78229, United States

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Webster, Texas, 77598, United States

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Draper, Utah, 84020, United States

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West Jordan, Utah, 84088, United States

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Henrico, Virginia, 23233, United States

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Norfolk, Virginia, 23507, United States

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Unknown Facility

Spokane, Washington, 99204-4880, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo

CTRinfo@dsi.com

908-992-6400

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2012
• First Posted: December 28, 2012
• Study Start: November 28, 2012
• Primary Completion: January 14, 2014
• Study Completion: January 14, 2014
• Last Updated: February 16, 2021
• Results First Posted: February 16, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

US (40)