Atopic dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Sponsors
Kymab Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults (= 18 years but =65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
Exclusion criteria: - Treatment with any of the following prior to first IMP administration (Baseline): ¤ Systemic corticosteroids and tacrolimus within 4 weeks; ¤ Systemic cyclosporin A within 3 weeks; ¤ Other systemic immunosuppressive or immunomodulatory drugs (including leukotriene inhibitors) within 3 months; ¤ Topical corticosteroids, tacrolimus or pimecrolimus, within 2 weeks; ¤ Prescription or non-prescription moisturisers with additives (e.g., urea, filaggrin) within 2 weeks; ¤ Phototherapy or allergen immunotherapy within 4 weeks; ¤ Regular use (> 2 visits/week) of a tanning booth/parlour within 4 weeks; ¤ Dupilumab within 3 months; ¤ Investigational therapy for the treatment of other conditions within 5 half-lives or the limit of PD effects or 3 months where the t1/2 is not known. - Known history of or suspected significant current immunosuppression, including history of invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration. - Treatment with a live (attenuated) immunisation within 12 weeks prior to Baseline. - Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breast feeding. - Basal and squamous cell skin cancer in the last 3 years prior to Baseline. Any other malignancies in the last 5 years prior to Baseline (excluding in situ cervical carcinoma). - Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody at the Screening Visit. - Severe concomitant illness that would in the Investigator’s opinion inhibit the patient’s participation in the study, including for example, but not limited to, renal disease, neurological conditions, heart failure and pulmonary disease. - Laboratory values at the Screening Visit: ¤ Serum creatinine > 1.6 mg/dL (141 µmol/L) in female patients and > 1.9 mg/dL (168 µmol/L) in male patients; ¤ Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × upper limit of normal (ULN); ¤ Platelet count ULN (except in circumstances where Gilbert`s Syndrome can be confirmed) - Participation in any other clinical study, including non-interventional studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To explore/characterise: To explore the effect of KY1005 on change in EASI over time - The effect of KY1005 on additional physician assessments of AD activity/severity (EASI, EASI 50, EASI 75, EASI 90, validated Investigator Global Assessment [vIGA], SCORing of Atopic Dermatitis [SCORAD] Index and affected body surface area [BSA]). - The effect of KY1005 on patient-reported AD activity/severity (Patient Oriented [PO] Eczema Measure [POEM], PO-SCORAD Index, Dermatology Quality of Life Index [DLQI] and Numerical Rating Scale [NRS] for pruritus). - The pharmacodynamic (PD) response to KY1005 including: ¤ change in histopathology; ¤ change in immunohistochemistry; ¤ the anti-KY1005 antibody response. - The pharmacokinetics (PK) of KY1005.;Primary end point(s): Co-primary endpoints: - Percentage change in EASI from Baseline to Day 113. - Incidence of TEAEs.;Timepoint(s) of evaluation of this end point: - Percentage change in EASI: from Baseline to Day 113 - Incidence of TEAEs to Day 113;Main Objective: To explore the efficacy and safety of KY1005 on the signs of atopic dermatitis (AD) using the Eczema Area and Severity Index (EASI) and the incidence of treatment-emergent adverse events (TEAEs). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Main secondary endpoints: Efficacy endpoint: - Percentage and absolute change from Baseline in EASI over time. PD and histopathology endpoints: - Change in epidermal thickness from Baseline to Day 113. - Change in immunohistochemistry staining from Baseline to Day 113. Additional secondary endpoints: Efficacy endpoints: - Percentage of patients with at least a 50% reduction from Baseline in EASI (EASI 50) to Day 113. - Percentage of patients with at least a 75% reduction from Baseline in EASI (EASI 75) to Day 113. - Percentage of patients with at least a 90% reduction from Baseline in EASI (EASI 90) to Day 113. - Change in vIGA from Baseline to Day 113 and over time. - Percentage of patients with a response of vIGA 0 or 1 at Day 113 and over time. - Change in SCORAD Index from Baseline to Day 113 and over time. - Change in affected BSA from Baseline to Day 113 and over time. - Change in POEM from Baseline to Day 113 and over time. - Change in PO-SCORAD Index from Baseline to Day 113 and over time. - Change in DLQI from Baseline to Day 113 and over time. - Change in NRS for pruritus from Baseline to Day 113 and over time. PD endpoints: - Immunogenicity titres at various timepoints from Baseline to Day 113. Pharmacokinetic endpoints for each patient (receiving KY1005) including: - Cmax - tmax - Cmin - AUC;Timepoint(s) of evaluation of this end point: Various timepoints for all endpoints assessment will be from Baseline to Day 113 and over time where indicated. | — |
Countries
Germany, Spain, United Kingdom
Contacts
Public ContactDevelopment Clinical Trial Desk
Kymab Limited
Outcome results
None listed