A Phase 3b, Interventional, Adaptive, Clinical Trial to Evaluate the Efficacy and Safety of Tralokinumab 300 mg Every Second Week Monotherapy Compared With Placebo in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- LEO Pharma
- Enrollment
- 235
- Locations
- 69
- Primary Endpoint
- Percentage of Participants With IGA-AHE Score of 0 (Clear) or 1 (Almost Clear)
Study Overview
Brief Summary
The purpose of this study is to test if treatment with tralokinumab is safe and efficacious in treating moderate-to-severe atopic hand eczema. This will be judged by a range of assessments that rate the severity and extent of atopic hand eczema and its symptoms, as well as general health status and quality of life.
The trial will last for up to 40 weeks for each participant. There will be up to 15 visits for each participant, 3 of which will be conducted by phone. The first part of the trial is called a screening period and will last up to 4 weeks. For the first 16 weeks after screening, trial participants will receive either tralokinumab or dummy injections every two weeks. After the first 16 weeks, all trial participants will receive tralokinumab injections every two weeks for 16 weeks. The last part of the trial is a period of 4 weeks after the end of treatment period, where trial participants will not receive tralokinumab but are monitored for safety.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or above at screening
- •Diagnosis of atopic dermatitis (AD) as by the Hanifin and Rajka (1980) criteria for AD
- •History of AD for ≥1 year
- •Presence of atopic hand eczema (AHE) that has persisted for more than 3 months or returned twice or more within the last 12 months, with avoidance of any known and relevant irritants and allergens
- •AD involvement of at least one body location other than the hands and wrists at screening
- •An Investigator's Global Assessment AHE score of 3 or 4 (moderate to severe) at screening and baseline
- •A HESD itch score (weekly average) of ≥4 at baseline
- •Subjects who have a documented recent history (within 12 months before the screening visit) of inadequate response to treatment of AHE with topical prescription medications or for whom topical treatments are otherwise medically inadvisable (e.g., due to important side effects or safety risks)
Exclusion Criteria
- •Subjects must not enter the trial if they have active subtypes of hand eczema other than AHE that are considered to be the predominant cause of the current hand eczema including:
- •Active irritant contact dermatitis
- •Active allergic contact dermatitis
- •Active protein contact dermatitis/contact urticaria
- •Active hyperkeratotic hand eczema
- •Active vesicular hand eczema (pompholyx)
- •Active dermatologic conditions that may confound the diagnosis of AD or AHE, or that would interfere with the assessment of treatment
- •Use of tanning beds or phototherapy (e.g., UVB, UVA1, PUVA), or Grenz ray therapy on the hands or wrists within 28 days prior to baseline or use of bleach baths on the hands or wrists within 7 days prior to baseline
- •Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 28 days prior to baseline
- •Treatment with topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase 4 inhibitors, or topical Janus kinase inhibitors within 7 days prior to baseline
- •Receipt of any marketed biological therapy (i.e. immunoglobulin, anti immunoglobulin E) including dupilumab or investigational biologic agents 3 to 6 months prior to baseline
Arms & Interventions
Placebo + tralokinumab
Placebo is administered for 16 weeks (double-blinded period) prior to roll-over to a 16 weeks open-label period where tralokinumab is administered
Intervention: Placebo (Drug)
Tralokinumab
Tralokinumab is administered for 32 weeks (16 weeks double-blinded period + 16 weeks open-label period)
Intervention: Tralokinumab (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With IGA-AHE Score of 0 (Clear) or 1 (Almost Clear)
Time Frame: At Week 16
IGA-AHE: The Investigator's Global Assessment for atopic hand eczema (IGA-AHE) is an instrument to rate the severity of the subject's AHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Secondary Outcomes
- Percentage of Participants Having a ≥2-point Reduction in IGA-AHE Score(From baseline to Week 16)
- Percentage of Participants Having a Decrease in HECSI of at Least 75% (HECSI-75)(From baseline (Day 1) to Week 16)
- Percentage of Participants Having a Decrease in HECSI of at Least 50% (HECSI-50)(From baseline to Week 16)
- Percentage of Participants Having a Decrease in HECSI of at Least 90% (HECSI-90)(From baseline to Week 16)
- Percentage Change in HECSI Score(From baseline to Week 16)
- Percentage of Participants With Reduction in HESD Itch Score (Weekly Average) of ≥4 Points(From baseline to Week 16)
- Percentage Change in HESD Itch Score (Weekly Average)(From baseline to Week 16)
- Percentage of Participants With Reduction in HESD Pain Score (Weekly Average) of ≥4 Points(From baseline to Week 16)
- Percentage Change in HESD Pain Score (Weekly Average)(From baseline to Week 16)
- Percentage Change in HEIS Score(From baseline to Week 16)
- Percentage Change in DLQI Score(From baseline to Week 16)
- Change in WPAI+CIQ:AHE Domain Scores(From baseline to Week 16)
- Number of Participants With IGA-AHE Score of 0 (Clear) or 1 (Almost Clear)(At Week 32)
- Number of Participants Having a Decrease in HECSI of at Least 75% (HECSI-75)(From baseline to Week 32)
- Number of Participants With Reduction in HESD Itch Score (Weekly Average) of ≥4 Points(From baseline to Week 32)
- Number of Participants With Reduction in HESD Pain Score (Weekly Average) of ≥4 Points(From baseline to Week 32)
- Percentage Change in HEIS Score(From baseline to Week 32)
- Percentage Change in DLQI Score(From baseline to Week 32)
- Change in WPAI+CIQ:AHE Domain Scores(From baseline to Week 32)
- Number of Treatment-emergent Adverse Events(From baseline to Week 16)
- Number of Treatment-emergent Adverse Events During the Open-label Treatment Period(Week 16 to Week 32)