Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02260986
• Date of registration: 06/10/2014
• Prospective Registration: No
• Primary sponsor: Regeneron Pharmaceuticals
• Public title: Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis CHRONOS
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Long-Term Safety of Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis
• Date of first enrolment: September 2014
• Target sample size: 740
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02260986
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Canada, Czech Republic, Czechia, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Latvia, Netherlands, New Zealand, Poland, Romania, Russian Federation, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: Clinical Trial Management
• Affiliation: Regeneron Pharmaceuticals

Key inclusion & exclusion criteria

Key Inclusion Criteria:

1. Chronic AD that had been present for at least 3 years before the screening visit;

2. Documented recent history (within 6 months before the screening visit) of inadequate
response to a sufficient course of out-patient treatment with topical AD
medication(s).

Key Exclusion Criteria:

1. Participation in a prior Dupilumab clinical trial;

2. Important side effects of topical medication (e.g. intolerance to treatment,
hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed
by the investigator or treating physician;

3. Having used any of the following treatments within 4 weeks before the baseline visit,
or any condition that, in the opinion of the investigator, was likely to require such
treatment(s) during the first 2 weeks of study treatment:

1. Immunosuppressive/immunomodulating drugs (e.g, systemic steroids, cyclosporine,
mycophenolate-mofetil, Janus kinase inhibitors, interferon-gamma [IFN-?],
azathioprine, methotrexate, etc.);

2. Phototherapy for AD;

4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;

5. History of human immunodeficiency virus (HIV) infection or positive HIV serology at
screening;

6. Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or
hepatitis C antibody at the screening visit;

7. Active or acute infection requiring systemic treatment within 2 weeks before baseline
visit;

8. Known or suspected history of immunosuppression;

9. Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during
the participant's participation in this study.

Note: The eligibility criteria listed above is not intended to contain all considerations
relevant to a participant's potential participation in a clinical trial therefore not all
inclusion/ exclusion criteria are listed.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Atopic Dermatitis

Intervention(s)

Drug: Dupilumab

Other: Topical Corticosteroid (TCS)

Drug: Placebo (for Dupilumab)

Primary Outcome(s)

Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of =2 Points at Week 16 [Time Frame: Baseline to Week 16]

Secondary Outcome(s)

Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 52 [Time Frame: Baseline to Week 52]

Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 52 [Time Frame: Baseline to Week 52]

Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 52 [Time Frame: Baseline to Week 52]

Percent Change From Baseline in Total Global Individual Signs Score (GISS) to Week 16 [Time Frame: Baseline to Week 16]

Percentage of Participants With Improvement (Reduction =4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 24 [Time Frame: Baseline to Week 24]

Percentage of Participants With Improvement (Reduction =4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52 [Time Frame: Baseline to Week 52]

Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 52 [Time Frame: Baseline to Week 52]

Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16 [Time Frame: Baseline to Week 16]

Number of Flares Through Week 52 [Time Frame: Baseline up to Week 52]

Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16 [Time Frame: Baseline to Week 16]

Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16 [Time Frame: Baseline to Week 16]

Proportion of Topical Atopic Dermatitis Medication-Free Days Through Week 52 [Time Frame: Baseline to Week 52]

Number of Serious Treatment Emergent Adverse Events (TEAEs) Leading to Study Drug Discontinuation Through Week 52 [Time Frame: Baseline up to Week 52]

Percentage of Participants With Improvement (Reduction =4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 [Time Frame: Baseline to Week 16]

Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (=75% Improvement From Baseline) at Week 16 [Time Frame: Baseline to Week 16]

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16 [Time Frame: Baseline to Week 16]

Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 52 [Time Frame: Baseline to Week 52]

Number of Skin Infection TEAEs (Excluding Herpetic Infections) From Baseline Through Week 52 [Time Frame: Baseline up to Week 52]

Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 52 [Time Frame: Baseline to Week 52]

Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16 [Time Frame: Baseline to Week 16]

Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (=75% Improvement From Baseline) at Week 52 [Time Frame: Baseline to Week 52]

Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16 [Time Frame: Baseline to Week 16]

Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 16 [Time Frame: Baseline to Week 16]

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 52 [Time Frame: Baseline to Week 52]

Number of Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52 [Time Frame: Baseline up to Week 52]

Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of =2 Points at Week 52 [Time Frame: Baseline to Week 52]

Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) From Baseline Through Week 52 [Time Frame: Baseline up to Week 52]

Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52 [Time Frame: Baseline up to Week 52]

Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16 [Time Frame: Baseline to Week 16]

Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 2 [Time Frame: Baseline to Week 2]

Percentage of Participants With Improvement (Reduction =3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 [Time Frame: Baseline to Week 16]

Percentage of Participants With Improvement (Reduction =3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52 [Time Frame: Baseline to Week 52]

Percentage of Participants With Improvement (Reduction =4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2 [Time Frame: Baseline to Week 2]

Percentage of Participants With Improvement (Reduction =4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4 [Time Frame: Baseline to Week 4]

Secondary ID(s)

R668-AD-1224

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi

Results

• Results available: Yes
• Date Posted: 17/10/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02260986