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A Phase II, randomized, placebo-controlled, double-blind, parallel-group, dose-finding, multicenter study to evaluate the efficacy and safety of nemolizumab in subjects with chronic pruritus of unknown origin

A Phase II, randomized, placebo-controlled, double-blind, parallel-group, dose-finding, multicenter study to evaluate the efficacy and safety of nemolizumab in subjects with chronic pruritus of unknown origin

Nishiura Tomoyuki

Maruho Co.,Ltd. Kyoto R&D Center

93 Chudoji Awatacho, Shimogyo-ku, Kyoto

ctinfo@mii.maruho.co.jp

- Clinical Trials Information

Maruho Co.,Ltd. Kyoto R&D Center

93 Chudoji Awatacho, Shimogyo-ku, Kyoto

+81-75-325-3279

ctinfo@mii.maruho.co.jp

Not Recruiting

Dec. 01, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Patients aged 13 years or older who have been diagnosed with chronic pruritus of unknown origin
- Patients with generalized or scalp/genital chronic pruritus of unknown origin
- Patients inadequate response despite treatment with oral antihistamines or antiallergic drugs for chronic pruritus of unknown origin for more than 2 weeks continuously in the past
- Patients unable to take oral antihistamines or antiallergic drugs

- Patients with serious illnesses such as heart, liver, kidney, lung, or blood diseases that make it difficult for them to participate in the clinical trial, as determined by the physician in charge.
- Patients with congestive heart failure
- Patients who have been treated for cancer in the past or are currently undergoing cancer treatment
- Patients with impaired immune function
- Patients undergoing hemodialysis or peritoneal dialysis
- Patients with hypersensitivity to immunoglobulin products (including previous hypersensitivity)
- Patients with poorly controlled asthma requiring systemic treatment by inhalation
- Patients with pruritus associated with dermatological or visceral diseases, or neurological/psychogenic/drug-induced pruritus
- Patients with body weight less than 30kg
- Patients with Hepatitis B virus or hepatitis C virus infection
- Patients with tuberculosis infection
- Pregnant, lactating, and possibly pregnant women or female patients who are unwilling to use adequate contraception under the guidance of a physician during the study period
- Patients who have participated in this clinical trial in the past and have undergone medical examinations and tests
- Patients who have received nemolizumab in the past

Both

Chronic pruritus of unknown origin

nemolizumab 60 mg, nemolizumab 30 mg or placebo at 4 week intervals for 16 weeks

Parcent change from baseline in weekly average of Peak pruritus-Numeric rate scale at Week16

+81-3-5213-0028

Dec. 13, 2024

No

none