To assess the long term safety and efficacy of treatment with BI 655130 in patients with AD who have completed and have responded to treatment in the parent study 1368-0032
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Solution for SC injection
CCT Research
Scottsdale, Arizona, United States
Clinical Physiology Associates
Fort Myers, Florida, United States
Finlay Medical Research Corp
Miami, Florida, United States
Number of Patients With Treatment Emergent Adverse Events (AEs) at Week 48
Number of patients with treatment emergent adverse events (AEs) at week 48. The treatment emergent adverse event refer to the adverse event with an onset between start of treatment and end of the 16-week residual effect period after the last dose of trial medication.
Time frame: From first dose until Week 48, up to 48 weeks.
Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 48
The EASI scoring system is used routinely in patients with psoriasis to describe signs and severity of the disease. It assesses the extent of disease at four body sites and measures four clinical signs: erythema, induration/papulation, excoriation, and lichenification (each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe)). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranges from 0 (clear) to 72 (very severe), with higher score indicating more severe disease extent and clinical signs. The percent change from baseline in EASI is calculated as: (EASI at week 48 - EASI at baseline) / EASI at baseline \* 100%.
Time frame: At baseline and at Week 48.
Percentage of Patients With a 50% Improvement From Baseline in EASI (EASI50) at Week 48
The EASI scoring system is used routinely in patients with psoriasis to describe signs and severity of the disease. It assesses the extent of disease at four body sites and measures four clinical signs: erythema, induration/papulation, excoriation, and lichenification (each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe)). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranges from 0 (clear) to 72 (very severe), with higher score indicating more severe disease extent and clinical signs. \[(EASI at week 48 - EASI at baseline) / EASI at baseline \* 100%\] ≥ 50%, then EASI50 = 1.
Time frame: At baseline and at Week 48.
Percentage of Patients With a 75% Improvement From Baseline in EASI (EASI75) at Week 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
ForCare Clinical Research, Inc.
Tampa, Florida, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
Unity Clinical Research
Oklahoma City, Oklahoma, United States
Dermatology Treatment and Research Center, PA
Dallas, Texas, United States
Innovaderm Research Inc.
Montreal, Quebec, Canada
Tennocho Ekimae Dermatology and Allergology
Kanagawa, Yokohama, Japan
Tokyo Medical University Hachioji Medical Center
Tokyo, Hachioji, Japan
The EASI scoring system is used routinely in patients with psoriasis to describe signs and severity of the disease. It assesses the extent of disease at four body sites and measures four clinical signs: erythema, induration/papulation, excoriation, and lichenification (each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe)). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranges from 0 (clear) to 72 (very severe), with higher score indicating more severe disease extent and clinical signs. \[(EASI at week 48 - EASI at baseline) / EASI at baseline \* 100%\] ≥ 75%, then EASI75 = 1.
Time frame: At baseline and at Week 48.
Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 48
The SCORing of Atopic Dermatitis (SCORAD) index assesses elements: extent of disease, disease severity and subjective symptoms. The SCORAD consists of three elements: extent of disease, intensity of disease, and subjective symptoms (Pruritus and Sleep Loss). These 3 aspects: extent of disease (A: score range 0-1-2), disease severity (B: score range 0-18), and subjective symptoms (C: score range 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103 for SCORAD score. The SCORAD range from 0 (no disease) to 103 (severe disease). The higher the SCORAD score, the more severe the Atopic Dermatitis is.
Time frame: At baseline and at Week 48.
Percentage of Patients Achieving at Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Investigator Global Assessment (IGA) at Week 48
The IGA scale allows investigators to assess overall disease severity at one given time point, and it consists of a five-point severity scale from clear to very severe disease (0= clear,1 =almost clear, 2 = mild disease, 3 = moderate disease, 4= severe disease). The IGA scale uses clinical characteristics of erythema, infiltration, papulation, oozing and crusting as guidelines for the overall severity assessment.
Time frame: At baseline and at Week 48.