Clinical trial NCT05870865
Conditions: Dermatitis, Atopic Pruritus
Keywords: Dermatitis, Atopic Pruritus Eczema Itch
Sponsor: TrialSpark
Start date: 2023-05-03; Completion date: 2023-12-28
Enrollment: 144 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this clinical trial is to evaluate ASN008 in people with itch caused by eczema. The main questions it aims to answer are:

* What is the efficacy and safety of ASN008?
* What is the impact of ASN008 on itch in patients with atopic dermatitis? Participants will be asked to apply topical ASN008, or matching vehicle (placebo containing no active drug), to their eczema lesions twice daily for 4 weeks.

Researchers will compare 3 different doses of ASN008 and a matching vehicle group to see which group responds best.

Detailed description:
All participants will sign an informed consent form and undergo screening (within 28 days prior to Day 1). During the screening period, all treatments for Atopic Dermatitis (AD) (also known as eczema) and/or itch will be stopped to allow for wash out, as applicable and according to eligibility requirements. Consistent daily or twice daily use of a non-prescription emollient is required at least 7 days prior to Day 1 and throughout the trial until the follow-up (Week 8). No other products, including, but not limited to, topical corticosteroids, calcineurin inhibitors, biologics, or Janus Kinase (JAK) inhibitors (topical or oral) may be used during the trial.

Eligible participants will be randomized in a 1:1:1:1 ratio to receive ASN008 gel 1.25 percent, ASN008 gel 2.5 percent, ASN008 gel 5.0 percent, or matching vehicle twice daily for 4 weeks (28 days), followed by a 4-week (28-day) follow-up period. The first dose of study treatment will be applied on Day 1 and the last dose will be applied on the morning of Day 28.

Participants will be required to participate in 8 scheduled visits: Screening; Randomization (remote visit); Day 1; Week 1 (Day 8); Week 2 (Day 15); Week 3 (Day 22); Week 4 (Day 28); and Week 8 (Day 56)/early termination (ET).

The trial duration per participant is up to 12 weeks (84 days): including up to 4 weeks (28 days) for the screening period, 4 weeks (28 days) for the treatment period, and up to 4 weeks (28 days) for the follow-up period.

A participant is considered to have reached the end of the trial when they have completed their Day 56 (Week 8) or ET visit. The trial will be considered complete when the last participant has completed their last trial visit.

Arms: arm 1: ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days) arm 2: ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days) arm 3: ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days) arm 4: ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
Interventions: intervention 1: ASN008 intervention 2: ASN008 Matching Vehicle
Intervention descriptions: intervention 1: ASN008 topical gel applied twice daily. intervention 2: The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.

Protocol documents:
Prot_000.pdf: 























































































































SAP_001.pdf: