Moderate to Severe Atopic Hand and Foot Dermatitis Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis
| Verified date | December 2023 |
| Source | Regeneron Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective of the study is to assess the efficacy of dupilumab on skin lesions in patients with atopic hand and foot dermatitis. The secondary objectives of the study are: - To assess the efficacy of dupilumab on various other domains (pruritus, pain, sleep loss, health related QoL, work life impairment) in patients with atopic hand and foot dermatitis - To evaluate the safety and tolerability of dupilumab administered to patients with atopic hand and foot dermatitis - To evaluate systemic exposure and immunogenicity of dupilumab in patients with atopic hand and foot dermatitis
| Status | Completed |
| Enrollment | 133 |
| Est. completion date | November 23, 2022 |
| Est. primary completion date | August 31, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility | Key Inclusion Criteria: - Patients with involvement of at least 2 anatomical areas at screening and baseline - Patients need to have an IGA hand and foot score of 3 or 4 (moderate-to-severe disease) at screening and baseline - Patients with documented recent history (within 6 months before the screening visit) of inadequate response of atopic hand and foot dermatitis to topical medication(s) - Patients meet the diagnosis criteria for atopic dermatitis (AD) - Provide informed consent/assent signed by study patient or legally acceptable representative - Patients need to have been compliant with the skin protection measures through the entire duration of the screening period Key Exclusion Criteria: - Treatment with dupilumab in the past - Patients with a positive patch test reaction that are deemed to be clinically relevant as the current cause of the hand and foot dermatitis - Patients with documented exposure to irritants believed to be a predominant cause of the current hand and foot dermatitis - Treatment with systemic corticosteroids or non-steroidal immunosuppressive drugs within 4 weeks prior to baseline - Known history of HIV/HBV/HCV infection - Pregnant or breastfeeding women or planning to become pregnant or breastfeed during the patient's participation in this study - Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment and during the study NOTE: Other protocol defined inclusion / exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Regeneron Study Site | Augsburg | |
| Germany | Regeneron Study Site | Berlin | |
| Germany | Regeneron Study Site | Berlin | |
| Germany | Regeneron Study Site | Bonn | |
| Germany | Regeneron Study Site | Dresden | |
| Germany | Regeneron Study Site | Frankfurt | Hessen |
| Germany | Regeneron Study Site | Gera | |
| Germany | Regeneron Study Site | Kiel | |
| Germany | Regeneron Study Site | Langenau | Baden Wurttemberg |
| Germany | Regeneron Study Site | Luebeck | |
| Germany | Regeneron Study Site | Mahlow | |
| Germany | Regeneron Study Site | Muenster | |
| Japan | Regeneron Study Site | Kawasaki | Kanagawa |
| Japan | Regeneron Study Site | Kyoto | |
| Japan | Regeneron Study Site | Osaka | |
| Japan | Regeneron Study Site | Sakai | Osaka |
| Japan | Regeneron Study Site | Shinjuku | Tokyo |
| Japan | Regeneron Study Site | Tachikawa | Tokyo |
| Japan | Regeneron Study Site | Tokyo | |
| Japan | Regeneron Study Site | Tokyo | |
| Poland | Regeneron Study Site | Bialystok | |
| Poland | Regeneron Study Site | Chorzow | |
| Poland | Regeneron Study Site | Katowice | |
| Poland | Regeneron Study Site | Katowice | |
| Poland | Regeneron Study Site | Kielce | |
| Poland | Regeneron Study Site | Ostrowiec Swietokrzyski | |
| Poland | Regeneron Study Site | Warszawa | |
| Poland | Regeneron Study Site | Warszawa | |
| Poland | Regeneron Study Site | Warszawa | |
| Poland | Regeneron Study Site | Wroclaw | |
| Poland | Regeneron Study Site | Wroclaw | |
| United States | Regeneron Study Site | Birmingham | Alabama |
| United States | Regeneron Study Site | Columbus | Indiana |
| United States | Regeneron Study Site | Houston | Texas |
| United States | Regeneron Study Site | Kew Gardens | New York |
| United States | Regeneron Study Site | Macon | Georgia |
| United States | Regeneron Study Site | Milwaukee | Wisconsin |
| United States | Regeneron Study Site | Mineola | New York |
| United States | Regeneron Study Site | Morgantown | West Virginia |
| United States | Regeneron Study Site | Norfolk | Virginia |
| United States | Regeneron Study Site | Portland | Oregon |
| United States | Regeneron Study Site | Redwood City | California |
| United States | Regeneron Study Site | Rockville | Maryland |
| United States | Regeneron Study Site | Saint Joseph | Missouri |
| United States | Regeneron Study Site | Saint Louis | Missouri |
| United States | Regeneron Study Site | Sandy Springs | Georgia |
| United States | Regeneron Study Site | Washington | District of Columbia |
| United States | Regeneron Study Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Regeneron Pharmaceuticals | Sanofi |
United States, Germany, Japan, Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16 | IGA is an assessment scale used to determine severity of hand and foot AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Higher score is indicative of more severe disease. | At week 16 | |
| Secondary | Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus Numerical Rating Scale (NRS) of =4 Points From Baseline to Week 16 | Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable). | Baseline to week 16 | |
| Secondary | Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS =3 From Baseline to Week 16 | Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable). | Baseline to week 16 | |
| Secondary | Percent Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS | Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable). | Baseline to week 16 | |
| Secondary | Percent Change in Modified Total Lesion Sign Score (mTLSS) for Hand/Foot Lesions From Baseline to Week 16 | mTLSS combines an evaluation of hand and foot eczema lesions severity; scores are summed, extending from a base estimation of 0 (no signs or symptoms) to the most extreme of 18 (more serious disease). | Baseline to Week 16 | |
| Secondary | Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS | Pain NRS Scale is an assessment tool used to report the intensity of a participant's pain. Participants will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain possible). | Baseline to week 16 | |
| Secondary | Mean Change From Baseline to Week 16 in Weekly Average of Daily Sleep NRS | Sleep NRS is an 11-point scale (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep. | Baseline to week 16 | |
| Secondary | Change From Baseline to Week 16 in Percent Surface Area of Hand and Foot Involvement With Atopic Dermatitis (AD) | Baseline to week 16 | ||
| Secondary | Percent Change From Baseline to Week 4 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS | Pruritus NRS is an assessment tool that is used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable). | Baseline to week 4 | |
| Secondary | Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS =4 From Baseline to Week 4 | Pruritus NRS is an assessment tool that is used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable). | Baseline to week 4 | |
| Secondary | Percent Change From Baseline to Week 16 in Hand Eczema Severity Index (HECSI) Score in Participants With Hand Dermatitis | For participants with hand dermatitis HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area). The range for the combined HECSI score is from 0 to 360 (5x6x3x4). | Baseline to week 16 | |
| Secondary | Percentage of Participants With HECSI-75 at Week 16 | HECSI-75 is defined as HECSI score has =75% improvement from baseline for participants with hand dermatitis. | At week 16 | |
| Secondary | Percentage of Participants With HECSI-50 at Week 16 | HECSI-50 is defined as HECSI score has =50% improvement from baseline, for participants with hand dermatitis. | At week 16 | |
| Secondary | Percentage of Participants With HECSI-90 at Week 16 | HECSI-90 is defined as HECSI score has =90% improvement from baseline for participants with hand dermatitis. | At week 16 | |
| Secondary | Change From Baseline to Week 16 in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) | For participants with hand dermatitis, QOLHEQ is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in those suffering from hand eczema. QOLHEQ overall scoring ranges as follows: 0 (best score) to 117 (worst score). | Baseline to week 16 | |
| Secondary | Mean Change From Baseline to Week 16 in Work Productivity and Impairment (WPAI) and Classroom Impairment Questionnaire (CIQ) | WPAI + CIQ is a self-administered instrument used to capture the impairment to work productivity/classroom impairment and activity due to atopic hand and foot dermatitis. The WPAI+CIQ yields 4 types of scores: absenteeism, presenteeism, work/classroom productivity loss and activity impairment. All scores range from 0 to 100% with 100% indicating total work/classroom productivity impairment and 0 no impairment at all. | Baseline to week 16 | |
| Secondary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 16 | Through week 16 | ||
| Secondary | Trough Concentration of Functional Dupilumab in Serum at Various Time Points | Up to week 28 | ||
| Secondary | Number of Participants With Treatment-Emergent (TE) Anti-Drug Antibody (ADA) | Up to week 28 | ||
| Secondary | Number of Participants With Treatment-Emergent ADA by Maximum Titer Category | Up to Week 28 |