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

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Brief Title

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

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis

Brief Summary

      The primary objective is to assess the efficacy of nemolizumab (CD14152) compared to placebo
      in participants greater than or equal to (>=) 18 years of age with prurigo nodularis (PN)
      after a 16-week treatment period.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Proportion of Participants with an Improvement of Greater than or Equal to (>=) 4 from Baseline in Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16

Secondary Outcome

 Number of Participants with Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)

Condition

Prurigo Nodularis

Intervention

Nemolizumab

Study Arms / Comparison Groups

 Nemolizumab
Description:  Participants weighing less than (<) 90 kilogram (kg) will receive two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W). Participants weighing greater than or equal to (>=) 90 kg will receive two SC injections of 60 mg nemolizumab at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks.

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

270

Start Date

August 11, 2020

Completion Date

October 31, 2021

Primary Completion Date

October 31, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Clinical diagnosis of PN for at least 6 months with: Pruriginous nodular lesions on
             upper limbs, trunk, and/or lower limbs, at least 20 nodules on the entire body with a
             bilateral distribution and Investigator Global Assessment (IGA) score >= 3 (based on
             the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the
             screening and baseline visits

          -  Severe pruritus defined as follows on the PP NRS:

               1. At the screening visit (Visit 1): PP NRS score is >= 7.0 for the 24-hour period
                  immediately preceding the screening visit.

               2. At the baseline visit (Visit 2): Mean of the daily intensity of the PP NRS score
                  is >= 7.0 over the previous week

          -  Female participants of childbearing potential (that is [i.e,], fertile, following
             menarche and until becoming post-menopausal unless permanently sterile) must agree to
             use at least 1 adequate and approved method of contraception throughout the study and
             for 12 weeks after the last study drug injection

        Exclusion Criteria:

          -  Body weight less than (<) 30 kg

          -  Chronic pruritus resulting from another active condition other than PN, such as but
             not limited to scabies, lichen simplex chronicus, psoriasis, atopic dermatitis,
             contact dermatitis, acne, folliculitis, lichen planus, habitual picking/excoriation
             disorder, sporotrichosis, bullous autoimmune disease, end-stage renal disease, or
             cholestatic liver disease (example [eg] primary biliary cirrhosis) or diabetes
             mellitus or thyroid disease that is not adequately treated, as per standard of care

          -  Unilateral lesions of prurigo (eg, only one arm affected)

          -  History of or current confounding skin condition (eg, Netherton syndrome, cutaneous
             T-cell lymphoma [mycosis fungoides or Sezary syndrome], chronic actinic dermatitis,
             dermatitis herpetiformis)

          -  Participants with a current medical history of chronic obstructive pulmonary disease
             and/or chronic bronchitis

          -  Neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica,
             brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional
             parasitosis

          -  Requiring rescue therapy for PN during the screening period or expected to require
             rescue therapy within 4 weeks following the baseline visit

          -  Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core
             antibody [HBcAb], hepatitis C (HCV) antibody with positive confirmatory test for HCV
             (eg, polymerase chain reaction [PCR]), or human immunodeficiency virus antibody) at
             the screening visit
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 817-961-5000, [email protected]

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT04501679

Organization ID

RD.06.SPR.203065

Secondary IDs

2019-004789-17

Responsible Party

Sponsor

Study Sponsor

Galderma R&D


Study Sponsor

, , 


Verification Date

March 2020