Safety and Efficacy of Nemolizumab in PN
Condition: Prurigo Nodularis
MeSH terms: Prurigo
Intervention: CD14152 Dose A; CD14152 placebo
Intervention description: 3 subcutaneous injections (every 4 weeks during the 12-week treatment period); 3 subcutaneous injections (every 4 weeks during the 12-week treatment period)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of this study is to assess the safety and efficacy of nemolizumab in subjects with
      prurigo nodularis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female of at least 18 years at screening

          2. Clinical diagnosis of PN for at least 6 months with:

               -  Prurigo lesions on upper limbs with or without lesions on the trunk or lower
                  limbs

               -  At least 20 nodules on the entire body with a bilateral distribution

          3. Severe pruritus defined as follows on a Numerical Rating Scale (NRS)

               -  At the Screening visit 1: Mean of the worst daily intensity of the NRS score is ≥
                  7 over the previous 3 days

               -  At the Baseline visit: Mean of the worst daily intensity of the NRS score is ≥ 7
                  over the previous week; NOTE: NRS score should be measured on at least 5 days
                  during the week preceding the baseline visit.

          4. Female subjects must fulfill one of the criteria below:

               -  Female subjects of non-childbearing potential (postmenopausal [absence of
                  menstrual bleeding for 1 year prior to screening, without any other medical
                  reason], hysterectomy or bilateral oophorectomy);

               -  Female subjects of childbearing potential who agree to a true abstinence (when in
                  line with the preferred and usual lifestyle of the subject), or to use an
                  effective method of contraception throughout the clinical trial and for 120 days
                  after the last study drug administration:

        Exclusion Criteria:

          1. Chronic pruritus resulting from another condition than PN such as scabies, insect
             bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking,
             lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis,
             sporotrichosis, bullous disease

          2. Unilateral lesions of prurigo (e.g only one arm affected)

          3. Cutaneous bacterial or viral infection within 1 week before the baseline visit.

          4. Infection requiring treatment with oral or parenteral antibiotics, antivirals,
             antiparasitics or antifungals within 1 week before the screening visit, or during the
             screening period, unless completely resolved at the screening/ baseline visits
             respectively,

          5. Any uncontrolled or serious disease, or any medical or surgical condition, that may
             either interfere with the interpretation of the clinical trial results and/or put the
             subject at Chronic pruritus resulting from another condition than PN such as scabies,
             insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual
             picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis,
             sporotrichosis, bullous disease