Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis

Browse trials for

• Dermatitis, Atopic 1,591

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's enrollment of 250 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.

Lead sponsor

Aclaris Therapeutics, Inc. is the lead sponsor of 33 studies on the registry; none are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 22 (88%) have results posted.

Study arms

• Experimental
  ATI-1777 topical solution 2.0% w/w (BID)

  ATI-1777 topical solution 2.0% w/w, twice daily

  Drug: ATI-1777 2.0% w/w

• Experimental
  ATI-1777 topical solution 1.0% w/w (BID)

  ATI-1777 topical solution 1.0% w/w, twice daily

  Drug: ATI-1777 1.0% w/w

• Experimental
  ATI-1777 topical solution 0.5% w/w (BID)

  ATI-1777 topical solution 0.5% w/w, twice daily

  Drug: ATI-1777 0.5% w/w

• Placebo comparator
  Vehicle (BID)

  Vehicle topical solution, twice daily

  Drug: Vehicle

• Experimental
  ATI-1777 topical solution 2.0% w/w (QD)

  ATI-1777 topical solution 2.0% w/w, once daily

  Drug: ATI-1777 2.0% w/w

• Placebo comparator
  Vehicle (QD)

  Vehicle topical solution, once daily

  Drug: Vehicle

Interventions

• DrugATI-1777 2.0% w/w

  ATI-1777 topical solution 2.0% w/w

• DrugATI-1777 1.0% w/w

  ATI-1777 topical solution 1.0% w/w

• DrugATI-1777 0.5% w/w

  ATI-1777 topical solution 0.5% w/w

• DrugVehicle

  Vehicle topical solution

Primary outcomes

1. Percentage change from baseline in Eczema Area and Severity Index Score (EASI) score at Week 4 (Day 28)

   EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.

   Time frame: Baseline to Day 28

Secondary outcomes

1. Percentage change from baseline in EASI score at each post-baseline study visit

   Time frame: Baseline to Day 42

2. Proportion achieving Investigator's Global Assessment-Treatment Success (IGA-TS) defined as Validated Investigator Global Assessment (vIGA) score of 0 or 1 with an improvement in vIGA of at least 2 points from baseline at each post-baseline study visit.

   IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.

   Time frame: Baseline to Day 42

3. Proportion of patients who achieve 50%, 75%, and 90% improvement in EASI score (EASI 50, EASI 75, and EASI 90, respectively) at each post-baseline study visit

   Time frame: Baseline to Day 42

4. Change from baseline in vIGA score at each post-baseline study visit

   Time frame: Baseline to Day 42

5. Change from baseline in Body Surface Area (BSA) at each post-baseline study visit

   BSA is defined as a percentage of the total body (0-100) that is affected by disease

   Time frame: Baseline to Day 42

6. Number of Participants With At Least One Adverse Event (AEs) and as Per Severity

   AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4.Data are reported for Grade 3 and higher severity for this outcome measure.

   Time frame: Baseline to Day 42

7. Change from baseline in Itch Numerical Rating Scale (PP NRS) from baseline to Day 28

   The Itch NRS is a once-per-24 hours ("daily") participant-reported measure of itch intensity to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. The categorical NRS is defined as 0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, and 7 to 10 = Severe.study visit

   Time frame: Baseline to Day 28