Phase 3
N=2,677
Open-label Study of Dupilumab in Patients With Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT01949311 ↗Enrolled (actual)
2,677
Serious AEs
10.6%
Results posted
Oct 2023
Primary outcome: Primary: Number of Treatment Emergent Adverse Events (TEAEs) — 14717 Number of Events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dupilumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment Emergent Adverse Events (TEAEs) |
14717 | — |
| PRIMARY OPTIONAL SUB-STUDY: Number of Adverse Events of Special Interest (AESIs) Through the Last Study Visit After Switching to the New Dupilumab Drug Product |
— | — |
| SECONDARY Number of Serious Adverse Events (SAEs) of Special Interest |
9 | — |
| SECONDARY Rate of AESIs |
2.762 | — |
| SECONDARY Number of AESIs |
161 | — |
| SECONDARY Percentage of Participants With Investigator's Global Assessment (IGA) Score = 0-1 at Each Visit |
12.0; 31.1; 46.7; 46.2; 53.8; 58.2 | — |
| SECONDARY Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (≥75% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit |
33.4; 65.3; 82.0; 85.3; 88.8; 91.4 | — |
| SECONDARY Percentage of Participants With Low Disease Activity State (eg, IGA ≤2) at Each Visit |
34.7; 70.0; 83.0; 84.6; 89.6; 90.9 | — |
| SECONDARY Change From Baseline in EASI Score at Each Visit |
-8.59; -11.89; -17.32; -16.46; -17.99; -17.68 | — |
| SECONDARY Percent Change From Baseline in EASI Score at Each Visit |
-42.02; -54.82; -60.40; -75.76; -82.61; -84.15 | — |
| SECONDARY Percentage of Participants With EASI-50 (≥50% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit |
86.0; 95.0; 96.7; 97.4; 98.5; 98.3 | — |
| SECONDARY Percentage of Participants With EASI-90 (≥90% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit |
38.6; 57.7; 59.7; 68.4; 73.0; 74.4 | — |
| SECONDARY Change From Baseline in Pruritus Numerical Rating Scale (NRS) in Parent Study |
-2.86; -3.81; -4.44; -4.67; -4.76; -4.69 | — |
| SECONDARY Percent Change From Baseline in Pruritus NRS |
-9.55; -28.88; -38.96; -41.38; -46.41; -50.62 | — |
| SECONDARY Percentage of Participants With Improvement (Reduction) of Pruritus NRS ≥3 From Baseline |
11.9; 28.3; 39.3; 43.8; 45.9; 51.1 | — |
| SECONDARY Percentage of Participants With Improvement (Reduction) of Pruritus NRS ≥4 From Baseline |
7.0; 18.6; 29.3; 33.3; 35.4; 41.4 | — |
| SECONDARY Percentage of Participants Requiring Rescue Treatment: Overall |
1.7 | — |
| SECONDARY Percentage of Participants Requiring Rescue Treatment: Systemic Treatment |
1.6 | — |
| SECONDARY Percentage of Participants Requiring Rescue Treatment: Phototherapy |
0.0747 | — |
| SECONDARY Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Dermatology Life Quality Index (DLQI) |
8.5; -4.9; -6.0; -6.5; -5.6; -7.2 | — |
| SECONDARY Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Patient Oriented Eczema Measure (POEM) |
-7.7; -9.3; -10.0; -8.8; -11.6; -11.4 | — |
| SECONDARY Changes From Parent Study Baseline to Prespecified Time Points Through the End of the Study: EuroQol-5D (EQ-5D) |
0.2769; 0.3001; 0.3056; 0.2854; 0.2965; 0.3217 | — |
| SECONDARY OPTIONAL SUB-STUDY: Ctrough of Functional Dupilumab in Serum Before and After Switching to the New Dupilumab Drug Product |
65.9; 65.4 | — |
| SECONDARY OPTIONAL SUB-STUDY: Incidence of Treatment-emergent Anti-drug Antibody (ADA) Response in Patients Receiving the New Dupilumab Drug Product |
— | — |
Summary
The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD).
The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment.
Optional Sub-Study:
The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product.
The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.
Eligibility Criteria
Key Inclusion Criteria
- Participation in a prior clinical trial of dupilumab for AD and met one of the following:
- Received study treatment and adequately completed the assessments required for both the treatment and follow-up periods of the parent studies (except studies listed in b) as defined in the parent protocols
- Received study treatment in one the studies that have completed last patient, last visit irrespective of duration of participation, provided that patients completed with the instructions received during the study.
- Underwent screening in R668-AD-1334 (Liberty AD SOLO 1) or R668-AD-1416 (Liberty AD SOLO 2) but could not be randomized due to randomization closure.
- Willing and able to comply with all clinic visits and study-related procedures
- Able to understand and complete study-related questionnaires
- Provide signed informed consent
Optional Sub-Study:
- Provide separate informed consent
- Continuing in the treatment period of the main OLE study
- Demonstrated compliance with dupilumab therapy, as defined in the protocol
Key Exclusion Criteria
- Patients who, during their participation in a previous dupilumab clinical trial, developed a serious adverse event (SAE) deemed related to dupilumab*, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
- Patients who, during their participation in a previous dupilumab clinical trial, developed an AE that was deemed related to dupilumab* and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
- Conditions in the previous dupilumab study consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to dupilumab* or led to investigator - or sponsor-initiated withdrawal of patient from the study (eg, non-compliance, inability to complete study assessments, etc.).
*Note for exclusion criteria # 1, 2, and 3: In studies that are still blinded, conditions deemed related to the study treatment will be considered related to dupilumab.
- Treatment with an investigational drug, other than dupilumab, within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
- Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the patient's participation in this study
Optional Sub-Study:
- Patients who have already completed the end of treatment visit (ie, visit 44) for the main study R668-AD-1225
Note: Other Protocol Defined Inclusion / Exclusion Criteria Apply.
Data sourced from ClinicalTrials.gov (NCT01949311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.