A Subcutaneous Dose Ranging Study of KY1005 in Patients with Moderate to Severe Atopic Dermatitis

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 350

Inclusion Criteria

• Adults (18 to < 75 years of age) with AD for 1 year or longer at Baseline.
• EASI of 12 or higher at the Screening Visit and 16 or higher at Baseline.
• IGA of 3 or 4 at Baseline.
• AD involvement of 10% or more of BSA at Baseline.
• Baseline worst/maximum pruritus NRS of = 4. The baseline weekly average of daily worst/maximum pruritus NRS will be calculated from the 7 consecutive days immediately preceding the Baseline visit.
• Documented history, within 6 months prior to Baseline, of either inadequate response or inadvisability of topical treatments.
• Must have applied a stable dose of topical bland emollient (simple moisturizer, no additives [e.g., urea]) at least twice daily for a minimum of 7 consecutive days before Baseline.
• Able to complete patient questionnaires, including collection of NRS (pruritus) on each of the 7 days prior to Baseline. .
• Able and willing to comply with requested study visits/telephone visits and procedures.
• Able and willing to provide written informed consent.
• For patients at sites selected for skin biopsy collection: able and willing to provide skin biopsies at required timepoints
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 335
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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 < 40 kg or > 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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