Safety and Efficacy of Nemolizumab in PN

Galderma

Status and phase: Completed; Phase 2

Conditions: Prurigo Nodularis

Treatments: Drug: CD14152 placebo; Drug: CD14152 Dose A

Study type: Interventional

Funder types: Industry

Identifiers

NCT03181503

RD.03.SPR.115828

Details and patient eligibility

About

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

Full description

This is a randomized, placebo-controlled, double-blinded, parallel group, multicenter study to evaluate the safety and efficacy of nemolizumab over a 12-week treatment period in patients suffering from prurigo nodularis compared to its placebo.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) every 4 weeks (Q4W) up to Week 8.

Treatment:

Drug: CD14152 placebo

Nemolizumab 0.5 mg/kg

Experimental group

Description:

Participants received 3 subcutaneous injections of nemolizumab 0.5 milligram per kilogram (mg/kg) Q4W up to Week 8.

Treatment:

Drug: CD14152 Dose A