Pilot Efficacy and Safety Study of AQX-1125 in Atopic Dermatitis

Browse trials for

• Dermatitis, Atopic 1,419
• Dermatitis 1,435
• Eczema 1,084

Keywords

• Atopic dermatitis
• Eczema
• AD
• AQX-1125
• SHIP1

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 54 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Lead sponsor

Aquinox Pharmaceuticals (Canada) Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Study arms

• Experimental
  AQX-1125

  1 x AQX-1125 Capsule daily

  Drug: AQX-1125

• Placebo comparator
  Placebo

  1 x placebo capsule daily

  Drug: Placebo

Interventions

• DrugAQX-1125

  Synthetic SHIP1 activator

• DrugPlacebo

Primary outcomes

1. Change From Baseline in Total Lesion Symptom Score (TLSS)

   The TLSS is an assessment of the severity of each of the following three signs: erythema, papulation/infiltration, excoriation and lichenification. Each of these items are rated using a 4-point scale severity where 0 is clear, 1 = mild, 2= moderate and 3 = severe. These ratings are then added to create a total score ranging from 0 to 12

   Time frame: 12 weeks

Secondary outcomes

1. Change From Baseline in Investigator's Global Assessment (IGA)

   The IGA is a global assessment of the current state of the disease. It is a 5-point morphological assessment of overall disease severity and will be determined according to the following categories: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe).

   Time frame: 12 weeks

2. Change From Baseline in Eczema Area and Severity Index (EASI) Score

   The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's atopic dermatitis based on both lesion severity and the percentage of body surface area (BSA) affected. Lesions are assessed on four domains; 1) erythema, 2) induration/papulation, 3) excoriation and 4) lichenification. Each domain is scored separately over four body regions (head/neck, upper limbs, trunk and lower limbs) on a scale of 0-3 (0 = none, 1 = mild, 2 = moderate and 3 = severe) with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region relative to the whole body. The sum of these scores provides the EASI total score, ranging from 0 to 72 with a higher score indicating greater severity of atopic dermatitis.

   Time frame: 12 weeks

3. Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score

   The severity scoring of atopic dermatitis (SCORAD) index is a standard tool to assess the atopic dermatitis (AD) severity in clinical studies. Six items; erythema, edema/papulation, oozing/crusts, excoriation, lichenification and dryness are measured on a scale from 0-3 for a total of 18 points, with a higher score indicating greater severity. The percentage of BSA affected by AD is evaluated (percentage divided by 5) and added to the total SCORAD score. Loss of sleep and pruritus are also evaluated by subjects on a visual analog scale (scores ranging from 0-10) with a higher score indicating greater severity. The sum of these measures represents the SCORAD which ranges from 0 (absent disease) to 103 (severe disease).

   Time frame: 12 weeks

4. Change From Baseline in Patient Oriented Eczema Measure (POEM) Score

   The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life.

   Time frame: 12 weeks

Baseline characteristics

Individual participant data

Plan to share: No