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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: Dupilumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04033367

2018-004705-26 (EudraCT Number)

LPS15497

U1111-1223-4147 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Duration per participant was up to 28 weeks.

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants, male or female 18 years or older,

• with diagnosed chronic AD, demonstrated 1) inadequate response to topical medications, 2) expected severity of AD and 3) sleep disturbance.
• had applied skin emollients (moisturizers) at least 7 days before screening.
• had applied medium potency topical corticosteroids (TCS) on all active AD lesions at least 7 days before screening.
• willed and able to comply with all clinic visits and study-related procedures.
• provided signed informed consent.

Exclusion criteria

Participants excluded from the study:

• with known hypersensitivity to Dupixent, clinical depression, drug abuse history, sleep problems not related to AD, irregular sleep pattern, active/acute infections, severe medical conditions, laboratory abnormalities, any condition that might present unreasonable risk to participants or interfered with study assessment, or any severe concomitant illness(es) that would adversely affect the participant's participation in the study, and contraindications of topical corticosteroids.
• at Baseline, presence of any conditions listed as criteria for study drug discontinuation.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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188 participants in 2 patient groups, including a placebo group

Dupilumab/Dupilumab

Experimental group

Description:

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.

Treatment:

Drug: Dupilumab

Placebo/Dupilumab

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Dupilumab