Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02277743
• Date of registration: 27/10/2014
• Prospective Registration: No
• Primary sponsor: Regeneron Pharmaceuticals
• Public title: Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis SOLO 1
• Scientific title: A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
• Date of first enrolment: October 2014
• Target sample size: 671
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02277743
• 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

Bulgaria, Canada, Denmark, Estonia, Finland, Germany, Japan, Singapore, Spain, United States

Contacts

• Name: Clinical Trial Management
• Affiliation: Regeneron Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female, 18 years or older

2. Chronic AD (according to American Academy of Dermatology Consensus Criteria
Eichenfield 2014) that has been present for at least 3 years before the screening
visit;

3. Eczema Area and Severity Index (EASI) Score =16 at the screening and baseline visits;

4. Investigator's Global Assessment (IGA) Score =3 (on the 0 to 4 IGA scale, in which 3
is moderate and 4 is severe) at the screening and baseline visits;

5. =10% body surface area (BSA) of AD involvement at the screening and baseline visits;

6. Documented recent history (within 6 months before the screening visit) of inadequate
response to treatment with topical medications or for whom topical treatments are
otherwise medically inadvisable (e.g, because of important side effects or safety
risks).

Exclusion Criteria:

1. Participation in a prior Dupilumab clinical study;

2. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if
known), whichever was longer, before the baseline visit;

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 4 weeks of study treatment:

- Immunosuppressive/ immunomodulating drugs (e.g, systemic corticosteroids,
cyclosporine, mycophenolate-mofetil, IFN-?, Janus kinase inhibitors,
azathioprine, methotrexate, etc.);

- Phototherapy for AD

4. Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI)
within 1 week before the baseline visit;

5. Treatment with biologics as follows:

- Any cell-depleting agents including but not limited to rituximab: within 6 months
before the baseline visit, or until lymphocyte count returns to normal, whichever
was longer

- Other biologics: within 5 half-lives (if known) or 16 weeks prior to baseline
visit, whichever was longer

6. Regular use (more than 2 visits per week) of a tanning booth/ parlor within 4 weeks of
the screening visit;

7. Planned or anticipated use of any prohibited medications and procedures during study
treatment;

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

9. Active chronic or acute infection requiring treatment with systemic antibiotics,
antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the
baseline visit, or superficial skin infections within 1 week before the baseline
visit. NOTE: Participants might be rescreened after infection resolves;

10. Known or suspected history of immunosuppression, including history of invasive
opportunistic infections (e.g, tuberculosis [TB], histoplasmosis, listeriosis,
coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or
unusually frequent, recurrent, or prolonged infections, per investigator judgment;

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

12. Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the
screening visit;

13. Participant was a member of the investigational team or his/her immediate family;

14. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
during the study;

15. Women unwilling to use adequate birth control, if of reproductive potential and
sexually active.

Note: The information listed above is not intended to contain all considerations relevant
to a participant's potential participation in this 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

Dermatitis, Atopic

Intervention(s)

Drug: Placebo (for Dupilumab)

Drug: 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: Week 16]

Secondary Outcome(s)

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

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

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

Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (=50% Improvement From Baseline) at Week 16 [Time Frame: Week 16]

Change From Baseline in Dermatology Life Quality Index (DLQI) to 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]

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

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

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

Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic Treatment [Time Frame: Baseline up to Week 16]

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

Percent Change From Baseline in Peak Daily Pruritus NRS Score to Week 2 [Time Frame: Baseline to Week 2]

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

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 16 [Time Frame: Baseline up to Week 16]

Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 16 [Time Frame: Baseline up to Week 16]

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

Percentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (=90% Improvement From Baseline) at Week 16 [Time Frame: Week 16]

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

Change From Baseline in 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) to Week 16 [Time Frame: Baseline to Week 16]

Secondary ID(s)

R668-AD-1334

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi

Results

• Results available: Yes
• Date Posted: 21/11/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02277743