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Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03654755
Recruitment Status : Enrolling by invitation
First Posted : August 31, 2018
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Asana BioSciences

Brief Summary:
This is a randomized open label study to evaluate the long term safety of ASN002 in subjects with moderate to severe atopic dermatitis (AD).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: ASN002 Phase 2

Detailed Description:
This is a randomized open label study where subjects with moderate to severe atopic dermatitis will roll over from the Phase 1 ASN002AD-101 and ASN002AD-201 Ph2b study and be randomized to receive ASN002 at 40mg, 60mg, or 80mg once daily for up to 24 months. This study will also characterize the pharmacokinetics of ASN002 through blood sampling from subjects who consent.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis
Actual Study Start Date : September 29, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Asparagine

Arm Intervention/treatment
Experimental: ASN002 40 mg
ASN002 40 mg
Drug: ASN002
Daily dose of ASN002 for up to 110 weeks

Experimental: ASN002 60 mg
ASN002 60 mg
Drug: ASN002
Daily dose of ASN002 for up to 110 weeks

Experimental: ASN002 80 mg
ASN002 80 mg
Drug: ASN002
Daily dose of ASN002 for up to 110 weeks




Primary Outcome Measures :
  1. Number and rate of treatment-emergent adverse events (TEAEs) [ Time Frame: 104 weeks ]

Secondary Outcome Measures :
  1. Number and rate of treatment related adverse events [ Time Frame: 104 weeks ]
  2. Change from baseline in Eczema Area Severity Index (EASI) score at each visit [ Time Frame: 4, 13, 26, 39, 52, 65, 78, 91, 104 weeks ]
  3. Proportion of subjects achieving an IGA of clear (0) or almost clear (1) at each visit [ Time Frame: 4, 13, 26, 39, 52, 65, 78, 91, 104 weeks ]
  4. Change from baseline in SCORing Atopic Dermatitis (SCORAD) at each visit [ Time Frame: 4, 13, 26, 39, 52, 65, 78, 91, 104 weeks ]
  5. Change from baseline in 5-D Pruritus (Itch) Scale at each visit [ Time Frame: 4, 13, 26, 39, 52, 65, 78, 91, 104 weeks ]
    The 5-D Pruritus (Itch) Scale is a multidimensional questionnaire which assesses itch-related quality of life. The questions cover five dimensions of itch including the degree, duration of itch/day, direction (improvement/worsening), disability (impact on activities such as work), and body distribution of itch. A lower total score represents better quality of life.

  6. Change from baseline in pruritus (itch) Numeric Rating Scale (NRS) at each visit [ Time Frame: 4, 13, 26, 39, 52, 65, 78, 91, 104 weeks ]
    Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable"

  7. Change from baseline in Body Surface Area (BSA) involved with AD at each visit [ Time Frame: 4, 13, 26, 39, 52, 65, 78, 91, 104 weeks ]
  8. Change from baseline in Patient-Oriented Eczema Measure (POEM) at each visit [ Time Frame: 4, 13, 26, 39, 52, 65, 78, 91, 104 weeks ]
  9. Change from baseline in Dermatology Life Quality Index (DLQI) at each visit [ Time Frame: 4, 13, 26, 39, 52, 65, 78, 91, 104 weeks ]
    This DLQI is a 10-question patient administered questionnaire that covers six quality of life domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment, with total scores ranging from 0-30 (less to more impairment)

  10. Measurement of plasma concentrations of ASN002 [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Subject with a history of moderate to severe atopic dermatitis who participated in the preceding ASN002AD-201 and ASN002AD-101 study
  • Subject must be a candidate for prolonged open label ASN002 treatment according to the investigator's judgment.
  • Subject has been using an emollient daily for at least 1 week prior to Day 1 and agrees to continue using that same emollient daily throughout the study.
  • Men and women participating in the study must use medically acceptable birth control or total abstinence from sexual intercourse
  • Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
  • Subjects must be willing to comply with all study procedures and must be available for the duration of the study.
  • Subject must be a candidate for prolonged open label ASN002 treatment according to the investigator's judgment.
  • Subject has a body mass index (BMI) ≤ 35 kg/m2.

Exclusion Criteria

  • Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
  • Subject has clinically infected atopic dermatitis.
  • A serious uncontrolled condition including hypertension, history of tuberculosis, hepatitis B or C infection, immune deficiency, heart disease, heart conduction disorder, diverticulitis, diabetes, reflux disease requiring protocol pump inhibitor therapy, malabsorption syndrome, or cancer
  • Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
  • Subject has a history of eczema herpeticum within 12 months, and/or a history of 2 or more episodes of eczema herpeticum in the past.
  • Willing to comply with discontinuation of certain treatments for AD, as directed by the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654755


  Show 38 Study Locations
Sponsors and Collaborators
Asana BioSciences
Investigators
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Study Director: David Zammit, Ph.D. Asana BioSciences

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Responsible Party: Asana BioSciences
ClinicalTrials.gov Identifier: NCT03654755     History of Changes
Other Study ID Numbers: ASN002AD-201-EXT
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asana BioSciences:
eczema
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases