Dupilumab for Pruritus

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Pruritus
Dupilumab - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial is testing a new drug, dupilumab, to see if it is safe and effective in treating adults with chronic pruritus of unknown origin (CPUO). The trial has two parts, study A and study B. In both parts, participants will use a non-sedative antihistamine and an emollient for 4 weeks before starting the trial medication. In study A, participants will be treated with dupilumab or placebo for 24 weeks, followed by a 12-week follow-up period. In study B, participants will be treated with dupilumab or placebo for 12 weeks, followed by a 12

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Pruritus

Study Objectives

3 Primary · 44 Secondary · Reporting Duration: Baseline to Week 36

Baseline to Week 12
Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 12
Study A: Absolute change from baseline in weekly average of daily sleep disturbances NRS at Week 12
Study A: Absolute change from baseline in weekly average of daily sleep disturbances numerical rating scale (NRS) at Week 12
Study A: Change from baseline in DLQI score at Week 12
Study A: Change from baseline in Dermatology Life Quality Index (DLQI) score at Week 12
Study A: Change from baseline in HADS total score at Week 12
Study A: Change from baseline in Hospital Anxiety and Depression Scale (HADS) total score at Week 12
Study A: Change from baseline in the Itchy quality of life (ItchyQoL) score at Week 12
Study A: Change from baseline in the ItchyQoL score at Week 12
Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 12
Study A: Percent change from baseline in weekly average of daily sleep disturbances NRS at Week 12
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
Study A; Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12
Study B: Absolute change from baseline in weekly average of daily WI-NRS at Week 12
Study B: Absolute change from baseline in weekly average of daily sleep disturbances NRS at Week 12
Study B: Change from baseline in DLQI score at Week 12
Study B: Change from baseline in HADS total score at Week 12
Study B: Change from baseline in the ItchyQoL score at Week 12
Study B: Percent change from baseline in weekly average of daily WI-NRS at Week 12
Study B: Percent change from baseline in weekly average of daily sleep disturbances NRS at Week 12
Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline over time until Week 12
Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12
Study B: Time to first response of WI-NRS ≥4 points reduction from baseline by Week 12
Baseline to Week 24
Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 24
Study A: Absolute change from baseline in weekly average of daily sleep disturbances NRS at Week 24
Study A: Absolute change from baseline in weekly average of daily sleep disturbances numerical rating scale (NRS) at Week 24
Study A: Change from baseline in DLQI score at Week 24
Study A: Change from baseline in Dermatology Life Quality Index (DLQI) score at Week 24
Study A: Change from baseline in HADS total score at Week 24
Study A: Change from baseline in Hospital Anxiety and Depression Scale (HADS) total score at Week 24
Study A: Change from baseline in the Itchy quality of life (ItchyQoL) score at Week 24
Study A: Change from baseline in the ItchyQoL score at Week 24
Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 24
Study A: Percent change from baseline in weekly average of daily sleep disturbances NRS at Week 24
Study A: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline over time until Week 24
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 24
Study A: Time to first response of WI-NRS ≥4 points reduction from baseline by Week 24
Study A; Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24
Study B: Incidence of treatment-emergent ADA against dupilumab
Study B: Percentage of participants experiencing TEAEs or SAEs from baseline through EOS
Baseline to Week 36
Study A: Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab
Study A: Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) from baseline through end of study (EOS)
Week 12
Study A: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 12
Study A: Proportion of participants who scored "none" or "mild" in Patient Global Impression of Severity (PGIS) of pruritus at Week 12
Study B: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 12
Week 24
Study A: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 24
Study A: Proportion of participants who scored "none" or "mild" in Patient Global Impression of Severity (PGIS) of pruritus at Week 24

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Pruritus

Side Effects for

OLE Period: Dupilumab/Dupilumab
12%Accidental Overdose
2%Dermatitis Atopic
2%Headache
2%Nasopharyngitis
2%Conjunctivitis
1%Multiple Fractures
1%Fall
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT04033367) in the OLE Period: Dupilumab/Dupilumab ARM group. Side effects include: Accidental Overdose with 12%, Dermatitis Atopic with 2%, Headache with 2%, Nasopharyngitis with 2%, Conjunctivitis with 2%.

Trial Design

2 Treatment Groups

Dupilumab
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

208 Total Participants · 2 Treatment Groups

Primary Treatment: Dupilumab · Has Placebo Group · Phase 3

DupilumabExperimental Group · 3 Interventions: Moisturizer, Dupilumab, Fexofenadine (loratadine if not available) · Intervention Types: Drug, Drug, Drug
PlaceboPlaceboComparator Group · 3 Interventions: Placebo, Moisturizer, Fexofenadine (loratadine if not available) · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Moisturizer
2008
Completed Phase 4
~240
Dupilumab
2017
Completed Phase 4
~12230

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 36

Who is running the clinical trial?

SanofiLead Sponsor
2,029 Previous Clinical Trials
2,908,161 Total Patients Enrolled
1 Trials studying Pruritus
23 Patients Enrolled for Pruritus

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have chronic pruritus affecting at least 2 of the following body areas: legs, arms, or trunk.
You have a history of chronic pruritus.
Participants should receive optimal treatment for concomitant conditions that could impact pruritus (eg, diabetes, iron deficiency).
You are aged 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.
You have chronic pruritus for at least 6 months before the screening visit.
You have an average worst itch score of at least 7 in the 7 days prior to run-in visit and in the 7 days prior to Day 1 on the WI-NRS.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: October 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Georgia100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Skin Care Physicians of Georgia-Site Number:8400030100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%