Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Safety of REGN668 Administered Concomitantly With Topical Corticosteroids to Patients With Moderate-to-Severe Atopic Dermatitis
Brief Summary: The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to-severe atopic dermatitis (AD).


Options:
A: Inclusion Criteria:

1. Male or female, 18 years or older;
2. Chronic AD diagnosed by the Eichenfield revised criteria of Hannifin and Rajka that had been present for at least 3 years before the screening visit;
3. Eczema Area and Severity Index (EASI) score ≥ 12 at the screening and baseline visits;
4. Investigator's Global Assessment (IGA) score ≥ 3 at the screening and baseline visits;
5. ≥ 10% body surface area (BSA) of AD involvement at the screening and baseline visits;
6. History of inadequate response to a stable (≥ 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit.

Exclusion Criteria:

1. Positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit;
2. Treatment with an investigational drug within 8 weeks or within 5 half-lives, if known, whichever is longer, before the baseline visit;
3. Treatment with leukotriene inhibitors within 4 weeks before the baseline visit;
4. Treatment with systemic corticosteroids within 4 weeks before the baseline visit;
5. Treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week before the baseline visit;
6. Systemic treatment for AD with an immunosuppressive/immunomodulating substance within 4 weeks before the baseline visit;
7. Chronic or acute infection requiring treatment with oral or IV antibiotics, antivirals, or antifungals within 4 weeks before the screening visit or superficial skin infections within 1 week before the screening visit;
8. Known history of human immunodeficiency virus (HIV) infection;
9. History of clinical parasite infection, other than treated trichomoniasis;
10. History of malignancy within 5 years before the baseline visit, with the following exceptions: participants with a history of completely treated carcinoma in-situ of cervix, and non-metastatic squamous or basal cell carcinoma of the skin were allowed;
11. Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the participant at risk, interfere with participation in the study, or interfere with the interpretation of study results;
12. Pregnant or breast-feeding women;
13. Unwilling to use adequate birth control, if of reproductive potential and sexually active.
B: Inclusion Criteria:

1. Male or female, 18 years or older;
2. Chronic AD that had been present for at least 3 years before the screening visit;
3. Patients with documented recent history (within 6 months before the screening visit) of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable;
4. Willing and able to comply with all clinic visits and study-related procedures.

Exclusion Criteria:

1. Prior participation in a Dupilumab clinical trial;
2. Treatment with an investigational drug within 8 weeks or within 5 half-lives before the baseline visit;
3. The following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, will likely require such treatment(s) during the first 4 weeks of study treatment:

   * Systemic corticosteroids;
   * Immunosuppressive/immunomodulating drugs;
   * Phototherapy for AD;
4. Treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the baseline visit;
5. Treatment with certain biologics;
6. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit;
7. Planned major surgical procedure during the participant's participation in this study;
8. Participant was a member of the investigational team or his/her immediate family;
9. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
10. Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study;

Note: The information 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.
C: Inclusion Criteria:

1. Male and female patients aged 18 years or older
2. Chronic AD that had been present for at least 2 years

Exclusion Criteria:

1. Prior treatment with Dupilumab
2. Hypersensitivity to corticosteroids or to any other ingredients contained by the TCS product used in the study
3. AD lesions located on face, flexural, and genital areas
4. Certain treatments and medical procedures, undertaken within a particular time frame prior to the baseline visit, preclude eligibility for participation in the study
5. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
6. Treatment with an investigational drug within 8 weeks
7. Known history of human immunodeficiency virus (HIV) infection
8. Presence of certain laboratory abnormalities at the screening visit
9. History of certain opportunistic infections or certain clinical parasite infections
10. History of malignancy within 5 years before the baseline visit, with certain exceptions
11. Pregnant or breast-feeding women
12. Travel within 12 months of study start to areas endemic for parasitic infections, such as developing countries in Africa and the tropical and subtropical regions of Asia
13. History of alcohol or drug abuse within 2 years of the screening visit
14. Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results
D: The inclusion criteria included, but were not limited to, the following:

1. Chronic Atopic Dermatitis that had been present for at least 3 years
2. History of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable (e.g, because of important side effects or safety risks)
3. Willing and able to comply with all clinic visits and study-related procedures

The exclusion criteria included, but were not limited to, the following:

1. Prior treatment with dupilumab (REGN668/SAR231893)
2. Presence of certain laboratory abnormalities at the screening visit
3. Treatment with an investigational drug within 8 weeks of baseline visit
4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
5. Certain other treatments and medical procedures undertaken within a particular time frame prior to the baseline visit
6. Known history of human immunodeficiency virus (HIV) infection
7. History of malignancy within 5 years before the baseline visit (with certain exceptions)
8. Planned surgical procedure during the length of the study
9. High risk of parasite infection
10. Any other medical or psychological condition that in the opinion of the investigator or the sponsor's medical monitor, would place the participants at risk, interfere with participation in the study or interfere with interpretation of study results
11. Pregnant or breast-feeding women

Answer: C