SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"

Conditions

• Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dupilumab — DRUG
  Pharmaceutical form: solution for injection Route of administration: subcutaneous
• Placebo — DRUG
  Pharmaceutical form: solution for injection Route of administration: subcutaneous

Study Details

Primary Objective: To evaluate the effect of dupilumab on sleep quality in adult participants with moderate to severe atopic dermatitis (AD). Secondary Objectives: To evaluate the effect of dupilumab on objective and subjective quantitative sleep parameters, AD related outcomes, and daytime consequences of sleep deprivation. To continue to assess the safety and tolerability throughout the study.

Key Dates

Start date

Aug 22, 2019

Status verified

Sep 2025

Primary completion

Oct 6, 2021

Completion

Oct 6, 2021

Study Design

Enrollment

188 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dupilumab/Dupilumab
  Participants received dupilumab 600 milligrams (mg) (loading dose) injection subcutaneously (SC) on Day 1 followed by dupilumab 300 mg injection SC every 2 weeks (q2w) up to Week 10 in the double-blind (DB) period of 12 weeks. After completion of DB period, participants entered in the open-label extension (OLE) period (Week 12 to 24) and continued to receive dupilumab 300 mg injection SC q2w from Week 12 up to Week 22.
• Placebo Comparator: Placebo/Dupilumab
  Participants received placebo matching to dupilumab injection SC on Day 1 then followed by placebo injection SC q2w up to Week 10 in the DB period of 12 weeks. After completion of DB period, participants entered in the OLE period (Week 12 to 24) and received dupilumab 600 mg (loading dose) at Week 12 followed by dupilumab 300 mg injection SC q2w up to Week 22.

Primary Outcome Measure

DB Period: Percent Change From Baseline in Sleep Quality Numerical Rating Scale (NRS) at Week 12 [ Time Frame: Baseline, Week 12 ]

Locations (8)

Find similar trials in North Little Rock, AR

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