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Trial record 7 of 80 for:    ASNS

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 16, 2018
First Posted Date  ICMJE August 31, 2018
Last Update Posted Date May 20, 2019
Actual Study Start Date  ICMJE September 29, 2018
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
Number and rate of treatment-emergent adverse events (TEAEs) [ Time Frame: 104 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03654755 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
  • Number and rate of treatment related adverse events [ Time Frame: 104 weeks ]
  • 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 ]
  • 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 ]
  • Change from baseline in SCORing Atopic Dermatitis (SCORAD) at each visit [ Time Frame: 4, 13, 26, 39, 52, 65, 78, 91, 104 weeks ]
  • 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.
  • 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"
  • 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 ]
  • Change from baseline in Patient-Oriented Eczema Measure (POEM) at each visit [ Time Frame: 4, 13, 26, 39, 52, 65, 78, 91, 104 weeks ]
  • 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)
  • Measurement of plasma concentrations of ASN002 [ Time Frame: 52 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis
Official Title  ICMJE 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
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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE Drug: ASN002
Daily dose of ASN002 for up to 110 weeks
Study Arms  ICMJE
  • Experimental: ASN002 40 mg
    ASN002 40 mg
    Intervention: Drug: ASN002
  • Experimental: ASN002 60 mg
    ASN002 60 mg
    Intervention: Drug: ASN002
  • Experimental: ASN002 80 mg
    ASN002 80 mg
    Intervention: Drug: ASN002
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: August 29, 2018)
256
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03654755
Other Study ID Numbers  ICMJE ASN002AD-201-EXT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Asana BioSciences
Study Sponsor  ICMJE Asana BioSciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Zammit, Ph.D. Asana BioSciences
PRS Account Asana BioSciences
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP