The goal of this clinical trial is to assess the efficacy and safety of ATTO-1310 in patients with chronic pruritus/itch of unknown origin.
The main questions it aims to answer are:
Does ATTO-1310 treatment alleviate symptoms of itch in participants with chronic pruritus/itch? What medical problems do participants have when taking ATTO-1310 for 24 weeks? Researchers will compare ATTO-1310 to a placebo (a look-alike substance that contains no drug). Participants will be dosed with ATTO-1310 or a placebo, visit the clinic for checkups and tests, and keep a diary of their symptoms.
Aged 18 to 90 years with a body weight of 50 to 125 kg and body mass index (BMI) between 18.5 and 40 kg/m².
History of chronic pruritus for at least 6 months that is considered of unknown origin (without a clear association to another condition or medication) as assessed by the Investigator.
Chronic pruritus must affect at least 2 of the following body areas: legs, arms, or trunk.
History of inadequate control of pruritus with at least 1 antihistamine within 6 months of Screening.
Known condition, other than dry skin, that is considered by the Investigator to be the primary cause of chronic pruritus, including: Presence of a primary dermatologic condition associated with pruritic skin lesions, regional neuropathic pruritus with the exception of peripheral small fiber neuropathy, severe renal failure, hepatobiliary disease, recent infectious dermatoses, suspected somatoform pruritus, ongoing drug-induced pruritus, malignancy or hemopathy, uncontrolled endocrine disease,
Liver function tests (bilirubin, AST, ALT, alkaline phosphatase) >2.5 times above the upper limit of normal
Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m²
History of malignancy within 5 years of Screening
Parallel
ATTO-1310
DrugATTO-1310
Placebo
DrugPlacebo preparation to match ATTO-1310 dose
7
Treatment groupsSee each treatment group below.
≥4-point improvement from baseline in Worst Itch Numerical Rating Scale (WI-NRS) at Week 12 (WI-NRS4 response)
Participants achieved a response if their WI-NRS improved 4 or more points from baseline on a scale ranging from zero (no itch) to 10 (worst possible itch). The baseline is calculated as the average in the final week prior to Day 1. The WI-NRS4 response endpoint at Week 12 is calculated as the average of the daily WI-NRS during Week 12 visit relative to the baseline average WI-NRS.
WI-NRS4 response at Week 4
Participants achieved a response if they had an improvement of at least 4 points on a scale ranging from 0 (no itch) to 10 (worst possible itch).
≥5-point improvement from baseline in WI-NRS (WI-NRS5 response) at Week 4
Participants achieved a response if they scored a 5 or more point improvement from baseline on a scale ranging from 0 (no itch) to 10 (worst possible itch).
≥5-point improvement from baseline in WI-NRS (WI-NRS5 response) at Week 12
Participants achieved a response if they scored a 5 or more point improvement from baseline on a scale ranging from 0 (no itch) to 10 (worst possible itch).
WI-NRS <2 (WI-NRS<2 response) at Week 4
Participants achieved a response if their WI-NRS score was less than 2 at Week 4
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This trial is not recruiting at the moment. You can still explore other options:
