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

Phase 1

Conditions: Atopic dermatitis
MedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2021-000725-28-DE

Lead Sponsor: Kymab Ltd, a Sanofi Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 350

Inclusion Criteria

• Adults (18 to < 75 years of age) with AD for 1 year or longer at
Baseline (Day 1; prior to first administration of IMP).For United
Kingdom, see Section 17.15.2 (Appendix 15).
• 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. This document must also actually be presented at the time of inclusion.
• For patients who decide to join the biopsy sub-study at sites selected for skin biopsy collection: be able and willing to provide skin biopsies at Baseline and Day113 (Week 16).
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 systemic 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 within 5 half-lives or within 12 weeks prior to baseline, whichever is longer;
•Previous treatment with systemic janus kinase (JAK)inhibitors at any
point.
•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 (>2visits/week) of a tanning booth/parlour within 4 weeks
•Any prior use of anti OX40 or anti OX40L mAb; including KY1005.
•Investigational therapy for the treatment of AD or other conditions
within 5 half-lives or the limit of PD effects or 12 weeks 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 14 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.Any malignancies or history of malignancies prior to Baseline(except for non-melanoma skin cancer that has been excised and cured for more than 3years prior to Baseline; 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 Scr-Visit).
10.Elective surgery planned to be scheduled for any time in the period from Screening up to 12 weeks following the last dose of IMP that in the investigator's opinion would impact the conduct of the trial.
11.Anticipated initiation of prohibited medications from Screening up to 12 weeks 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