Safety and Efficacy of Nemolizumab in PN

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Brief Title

Safety and Efficacy of Nemolizumab in PN

Official Title

A Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis (PN)

Brief Summary

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

Detailed 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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) Score at Week 4 Using Last Observation Carried Forward (LOCF) Approach

Secondary Outcome

 Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach

Condition

Prurigo Nodularis

Intervention

CD14152 Dose A

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

70

Start Date

October 2, 2017

Completion Date

September 26, 2018

Primary Completion Date

September 26, 2018

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Austria

Location Countries

Austria

Administrative Informations


NCT ID

NCT03181503

Organization ID

RD.03.SPR.115828


Responsible Party

Sponsor

Study Sponsor

Galderma R&D


Study Sponsor

, , 


Verification Date

November 2019