Chronic pruritus of unknown origin (CPUO) MedDRA version: 24.1 Level: PT Classification code 10037087 Term: Pruritus System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Dupilumab
Product Code: SAR231893
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Dupilumab
Current Sponsor code: SAR231893
Other descriptive name:
Sponsors
Sanofi-aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 90 years of age inclusive, at the time of signing the informed consent. - Participants with chronic pruritus for at least 6 months before the screening visit. - Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (excluding chronic pruritus secondary to dermatological or systemic conditions, of neuropathic or psychogenic origin or secondary to drugs). - Chronic pruritus must affect at least 2 of the following body areas: legs, arms, or trunk. - History of insufficient control of the chronic pruritus with prior treatment. - Participants should receive optimal treatment for concomitant conditions that could impact pruritus (eg, diabetes, iron deficiency). - Participants must have a history of severe itch and a worst itch score of =7 at screening on the WI-NRS (score scale ranges from 0 to 10; higher score indicates worse itch) and Patient global impression of severity (PGIS) of pruritus scored “severe” at screening. - Participants must have an average worst itch score of =7 in the 7 days prior to run-in visit and in the 7 days prior to Day 1 on the WI-NRS. - Participants scored “severe” in the PGIS of pruritus on Day 1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 227 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 226
Exclusion criteria
Exclusion criteria: - Severe concomitant illness(es) that, in the Investigator’s judgment, would adversely affect the patient’s participation in the study. - Patients with active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis, unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent. - Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before the screening visit. - HIV infection. - Severe renal failure (dialysis). - Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the run-in visit. - Known or suspected immunodeficiency. - Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin. - History of hypersensitivity or intolerance to non-sedative antihistamines. - Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Study A and B: • To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with CPUO • To demonstrate the improvement in sleep, anxiety and depression, and health-related quality of life (HRQoL) • To evaluate safety outcome measures • To evaluate immunogenicity of dupilumab;Primary end point(s): 1 - Study A: Proportion of participants with improvement (reduction) in weekly average of daily worst-itch numerical rating scale (WI-NRS) by =4 from baseline to Week 12 ; WI-NRS is a patient reported outcome (PRO) comprised of a single item rated on a scale from 0 (“No itch”) to 10 (“Worst imaginable itch”). 2 - Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by =4 from baseline to Week 12 ; WI-NRS is a PRO comprised of a single item rated on a scale from 0 (“No itch”) to 10 (“Worst imaginable itch”).;Timepoint(s) of evaluation of this end point: 1,2 : Baseline to Week 12;Main Objective: Study A and B: • To demonstrate the efficacy of dupilumab on itch response in participants with CPUO | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - Study A: Proportion of participants who scored “none” or “mild” in Patient Global Impression of Severity (PGIS) of pruritus at Week 12 2 - Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 12 3 - Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 12 4 - Study A; Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by =4 from baseline to Week 24 5 - Study A: Proportion of participants who scored “none” or “mild” in PGIS of pruritus at Week 24 6 - Study A: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by =4 from baseline over time until Week 24 7 - Study A: Time to first response of WI-NRS =4 points reduction from baseline by Week 24 8 - Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 24 9 - Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 24 10 - Study A: Absolute change from baseline in weekly average of daily sleep disturbances numerical rating scale (NRS) at Week 12 11 - Study A: Percent change from baseline in weekly average of daily sleep disturbances NRS at Week 12 12 - Study A: Change from baseline in Dermatology Life Quality Index (DLQI) score at Week 12 13 - Study A: Change from baseline in the Itchy quality of life (ItchyQoL) score at Week 12 14 - Study A: Change from baseline in Hospital Anxiety and Depression Scale (HADS) total score at Week 12 15 - Study A: Absolute change from baseline in weekly average of daily sleep disturbances NRS at Week 24 16 - Study A: Percent change from baseline in weekly average of daily sleep disturbances NRS at Week 24 17 - Study A: Change from baseline in DLQI score at Week 24 18 - Study A: Change from baseline in the ItchyQoL score at Week 24 19 - Study A: Change from baseline in HADS total score at Week 24 20 - Study A: Percentage of participants experiencing treatment-emergent adverse events | — |
Countries
Argentina, Canada, China, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Poland, Spain, United States
Contacts
Public ContactUnidad de Estudios Clínicos
Sanofi-Aventis, S.A
Outcome results
None listed