Atopic dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Product Name: KY1005
Product Code: SAR445229
Pharmaceutical Form: Solution for injection
INN or Proposed INN: amlitelimab
CAS Number: 2378692-15-8
Current Sponsor code: KY1005 and SAR445229
Other de
Sponsors
Kymab Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adults (18 to =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Treatment with any of the following prior to first IMP administration (Baseline): •Systemic corticosteroids, and calcineurin inhibitors (tacrolimus and cyclosporin) within 4 weeks; •Leukotriene inhibitors within 4 weeks; •Systemic therapy for AD, including but not limited to methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4 (PDE4)-inhibitors, IFN-? and mycophenolate mofetil within 4 weeks; •Targeted biologic and small molecule treatments (e.g., dupilumab, janus kinase [JAK] inhibitors) within 5 half-lives or within 12 weeks, whichever is longer; •Topical corticosteroids, tacrolimus or pimecrolimus, or topical PDE4 within 7 days; •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; •Any prior use of anti OX40 or anti OX40L mAb; •Investigational therapy for the treatment of AD or other conditions within 5 half-lives or the limit of PD effects or 3 months where the t1/2 is unknown. 2. Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminth infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration. 3. Weight 150 kg at Baseline. 4. Treatment with a live (attenuated) immunisation within 12 weeks prior to Baseline; completion of required administrations of COVID-19 vaccine within 14 days prior to Baseline or within 7 days immediately prior to or following IMP administration. 5. Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding . 6. 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 that has been excised and cured). 7. Positive for human immunodeficiency virus, hepatitis B surface antigen, hepatitis B core antibody or hepatitis C antibody at the Screening Visit. 8. History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator. 9. Current or any past history of tuberculosis or non-tuberculous mycobacterial infections (including a positive QuantiFERON®-Tuberculosis Gold blood test at the Screening Visit). 10. Elective surgery planned to be scheduled for any time in the period up to 3 months following the last dose of IMP. 11. Anticipated initiation of prohibited medications up to 3 months following the last dose of IMP. 12. 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, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease. 13. Skin comorbidity that would adversely affect the ability to undertake AD assessments. 14. Any medical or psychiatric condition which, in the opinion of the investigator may present an unreasonable risk to the study patient as a result of his/her participation in this clinical study, may make patient’s participation unreliable, or may interfere with study assessments. 15. Any active or chronic infection requiring systemic treatment within 2 weeks prior to Baseline (1 week in the event of superficial skin infections). 16. In the Investigator’s opinion, any clinicall
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the efficacy (including dose/exposure-response) across a range of KY1005 exposures, compared to Placebo, on the signs of Atopic Dermatitis (AD) using the Eczema Area and Severity Index (EASI) in those patients with a documented history, within 6 months prior to Baseline, of either inadequate response to topical treatments or inadvisability of topical treatments. Dose response of 4 different dose regimens of KY1005 in patients with AD versus Placebo will be evaluated.;Secondary Objective: To characterize: *The efficacy (including dose/exposure-response) across a range of KY1005 exposures compared to Placebo on additional physician assessments of AD activity/severity: EASI at week24, EASI-75, IGA and NRS for pruritus. Also characterize: *Safety and tolerability of KY1005 *The PK profile of KY1005 across a range of doses/exposures *The response across a range of KY1005 exposures on additional physician assessments of AD activity/severity EASI, EASI-50, EASI-75, EASI-90, EASI-100, IGA, SOCRAD and affected BSA. *The response across range of KY1005 exposures on patient-reported AD activity/severity; POEM, DLQI, ADCT, HADS & NRS for pruritus. *The PD response to KY1005 including but not limited to; the immunogenicity of KY1005, including the anti-KY1005 antibody response. *The maintenance of clinical response with in patients randomized to withdrawal of IMP who achieve = EASI-75 or who attain IGA 0/1 response following 24 weeks of treatment.;Primary end point(s): Percentage change in EASI from Baseline to Day 113.;Timepoint(s) of evaluation of this end point: Day 113 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Safety endpoint: • Incidence of treatment emergent adverse events including AESIs. -Pharmacokinetic endpoint: • Serum KY1005 concentration for each patient (receiving KY1005). -Key secondary efficacy endpoints: • Percentage change from Baseline in EASI at Days 169. • Percentage of patients with at least a 75% reduction from Baseline in EASI (EASI-75) at Days 113 and 169. • Percentage of patients with a response of IGA 0 or 1 and a reduction from Baseline of = 2 points at Days 113 and 169. • Proportion of patients with improvement (reduction) of weekly average of pruritus NRS = 4 with a Baseline pruritis NRS of = 4 from Baseline to Days 113 and 169. Other secondary efficacy endpoints: • Absolute change from Baseline in EASI at Days 15, 29, 57, 85, 113, 141 and 169. • Percentage change from Baseline in EASI at Days 15, 29, 57, 85 and 141. • Percentage of patients with at least a 50% reduction from Baseline in EASI (EASI-50) at Days 15, 29, 57, 85, 113, 141 and 169. • Percentage of patients with at least a 75% reduction from Baseline in EASI (EASI-75) at Days 15, 29, 57, 85 and 141. • Percentage of patients with at least a 90% reduction from Baseline in EASI (EASI-90) at Days 15, 29, 57, 85, 113, 141 and 169. • Percentage of patients with a 100% reduction from Baseline in EASI (EASI-100) at Days 15, 29, 57, 85, 113, 141 and 169. • Change in IGA from Baseline to Day 113 and over time. • Percentage of patients with a response of IGA 0 or 1 and a reduction from Baseline of = 2 points at Days 15, 29, 57, 85 and 141. • Absolute and percentage change in SCORAD Index from Baseline to Day 169 and over time. • Absolute and Percentage change in affected BSA from Baseline to Day 169 and over time. • Absolute and Percentage change in POEM from Baseline to Day 169 and over time. • Absolute and Percentage change in DLQI from Baseline to Day 169 and over time. • Absolute and Percentage change in ADCT from Baseline to Day 169 and over time. • Absolute and Per | — |
Countries
Australia, Bulgaria, Canada, Czechia, Germany, Hungary, Japan, Poland, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactDevelopment Clinical Trial Desk
Kymab Limited
Outcome results
None listed