TrialSpark has dosed the first patient in a Phase II clinical trial of ASN008-201 gel for the treatment of pruritus associated with atopic dermatitis (AD).
The vehicle-controlled, double-blind, randomised trial will assess the anti-pruritic efficacy of ASN008 in adult patients with mild to moderate AD.
It will also evaluate the safety, pharmacokinetics, and tolerability of ASN008, a topical sodium channel blocker.
The trial intends to enrol up to 120 participants at nearly 28 study centres across the US.
Eligible participants will receive ASN008 1.25%, 2.5%, 5%, or a matching vehicle in a 1:1:1:1 ratio twice daily for four weeks.
They will also be followed for four weeks after the treatment.
TrialSpark chief development officer Gavin Corcoran said: “Dermatology is a core focus area for our company, and there is enormous unmet patient need, so we’re looking forward to progressing this clinical trial as efficiently as possible.”
Topline data from the trial is anticipated next year.
Pruritus is said to be the most prevalent and burdensome symptom in patients with AD, a chronic inflammatory skin disease.
TrialSpark CEO and co-founder Benjamine Liu said: “We are grateful to the patients who are participating in this clinical trial and to the healthcare professionals who are working with us to advance our research.
“Our company’s mission is to bring new treatments to patients faster than ever before, and the contributions of patients, doctors, and sites are essential to achieving that goal.”