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Phase 2B Study to Evaluate ASN002 in Subjects With Moderate to Severe Atopic Dermatitis (RADIANT)

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ClinicalTrials.gov Identifier: NCT03531957
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Asana BioSciences

Brief Summary:
This is a randomized double-blind/placebo study evaluate the efficacy of ASN002 in subjects with moderate to severe atopic dermatitis (AD).

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

Detailed Description:
This is a placebo controlled study where subjects with moderate to severe atopic dermatitis will be randomized (1:1:1:1) to receive ASN002 at 40 mg, 60 mg, or 80 mg, or placebo once daily for 12 weeks. Eligible subjects will get the opportunity to enroll in the 24 month open-label extension study (OLE). There will be a 4-week follow up period for subjects not participating in the OLE study. This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and three or four biopsies from subjects who consent.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 2B Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : August 2019

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
40 mg ASN002
Drug: ASN002
Daily dose of ASN002 for 12 weeks

Experimental: ASN002 60 mg
60 mg ASN002
Drug: ASN002
Daily dose of ASN002 for 12 weeks

Experimental: ASN002 80 mg
80 mg ASN002
Drug: ASN002
Daily dose of ASN002 for 12 weeks

Experimental: Placebo Oral Tablet
Matching placebo for ASN002 doses
Drug: Placebo Oral Tablet
Placebo of ASN002 for 12 weeks




Primary Outcome Measures :
  1. Change from baseline in Eczema Area and Severity Index (EASI) [ Time Frame: 12 weeks ]
    Change from baseline in EASI at week 12


Secondary Outcome Measures :
  1. Proportion of subjects with at least a 50% reduction from baseline in EASI (EASI50) [ Time Frame: 2, 4, 8, and 12 weeks ]
    Reduction of EASI compared to baseline

  2. Proportion of subjects with at least a 75% reduction from baseline in EASI (EASI75) [ Time Frame: 2, 4, 8, and 12 weeks ]
    Reduction of EASI compared to baseline

  3. Proportion of subjects with at least a 90% reduction from baseline in EASI (EASI90) [ Time Frame: 2, 4, 8, and 12 weeks ]
    Reduction of EASI compared to baseline

  4. Change from baseline in 5-D Pruritus (itching) Scale [ Time Frame: 2, 4, 8, and 12 weeks ]
    Change from baseline in 5-D Pruritus (itching) Scale

  5. Change from baseline in SCORing Atopic Dermatitis (SCORAD) [ Time Frame: 2, 4, 8, and 12 weeks ]
    Change from baseline in SCORing Atopic Dermatitis (SCORAD)

  6. Proportion of Participants with a Response of Investigator's Global Assessment (IGA) 0 or 1 [ Time Frame: 2, 4, 8, and 12 weeks ]
    Proportion of Participants with a Response of IGA 0 or 1

  7. Change from baseline in Patient-Oriented Eczema Measure (POEM) [ Time Frame: 2, 4, 8, and 12 weeks ]
    Change from baseline in POEM

  8. Change from baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: 2, 4, 8, and 12 weeks ]
    Change from baseline in DLQI

  9. Change from baseline in Body Surface Area (BSA) [ Time Frame: 2, 4, 8, and 12 weeks ]
    Change from baseline in BSA



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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:

  • Written informed consent obtained prior to any study-related procedure being performed;

    • Male or female, 18≤ years and ≤75 years of age with chronic AD for at least 6 months.
    • At least 10% body surface area (BSA) of AD involvement at the baseline visits
    • Has a body mass index (BMI) ≤35 kg/m2
    • History of inadequate response to topical corticosteroids or calcineurin inhibitors as treatment for AD within 1 year before the screening visit.
    • Willing to apply only a basic bland emollient once or twice-daily for at least 7 days before the baseline visit.
    • Willing to comply with discontinuation of certain treatments for AD, as directed by the Investigator.
    • Willing to use medically effective methods of birth control
    • Females of reproductive potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1..
    • Willing and able to comply with clinic visits and study-related procedures

Exclusion Criteria:

  • Clinically infected atopic dermatitis.

    • Presence of any of the following laboratory abnormalities at the screening visit: Hemoglobin < 11 g/dL, White blood cell (WBC) < 3.0 x 103 /μL, Platelet count < 125 x 103 /μL, Neutrophils < < 2.50 x 103 /μL, Lymphocytes ≤ 1.2 x 103 /μL, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 1.5 x the upper limit of normal (ULN),Total bilirubin > ULN (except for elevated indirect bilirubin secondary to Gilbert's syndrome), Creatinine > ULN
    • 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.
    • Any condition requiring the use of anticoagulants.
    • History of hypertrophic scarring or keloid formation in scars or suture sites.
    • Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results
    • Pregnant or breast-feeding women
    • Known hypersensitivity to ASN002 or its excipients;
    • Prior treatment with SYK or JAK inhibitors for which the subject received no clinical benefit, or the subject relapsed whilst on therapy.
    • Has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
    • Planned major surgical procedure during the length of the patient's participation in this study
    • There will be a waiting period of 4 weeks before receiving the first does for anyone who has used oral or intravenous treatments (other than biologics) that could affect atopic dermatitis, received a non-biological investigational product or device, excessive sun exposure, is planning a trip to a sunny climate, or has used tanning booths, or received or plans to receive a live attenuated vaccine one four weeks after the last day of taking the drug.

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): NCT03531957


Contacts
Contact: Peter Pelka 609-557-1236 peter.pelka@asanabio.com
Contact: Jaimini Shah 908-698-0798 jaimini.shah@asanabio.com

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

Responsible Party: Asana BioSciences
ClinicalTrials.gov Identifier: NCT03531957     History of Changes
Other Study ID Numbers: ASN002AD-201
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

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:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases