Clinical trial NCT03754309: A Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis
Official title: A Phase 2a, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicentre Study of an Anti OX40L Monoclonal Antibody (KY1005) in Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatitis, Atopic
Lead sponsor: Kymab Limited
Sponsor class: INDUSTRY
First posted: 2018-11-27
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Primary analysis up to day 113. Long term follow up to day 253 (dependent on response).
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to investigate if KY1005 results in improvement of eczema when given to participants with moderate to severe disease. Side effects of KY1005 will also be explored.

Detailed description: Phase 2a, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety and tolerability of two doses of KY1005 in adults with moderate to severe atopic dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable.

Eligibility criteria: Inclusion Criteria:

* Adults (greater than or equal to \[\>=\] 18 years but less than \[\<\] 75 years of age) with Atopic Dermatitis (AD) for 1 year or longer at Baseline (Day 1; prior to first administration of Investigational Medicinal Product \[IMP\]).
* Eczema Area and Severity Index (EASI) of 12 or higher at the Screening Visit and 16 or higher at Baseline.
* validated Investigator Global Assessment (vIGA) of 3 or 4 at Baseline.
* AD involvement of 10 percent or more of body surface area at Baseline.
* Documented history, within 6 months prior to Baseline, of either inadequate response to topical treatments 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 at least 7 consecutive days before Baseline.
* Able and willing to comply with requested study visits/telephone visits and procedures.
* Able and willing to provide punch biopsy of both lesional and non-lesional skin at Baseline.
* Able and willing to provide written informed consent.

Exclusion Criteria:

* Recent treatment within specific time windows before the baseline visit for the management of atopic dermatitis such as topical or systemic corticosteroids, biologic or investigational therapies and/or phototherapy.
* 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.
* 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).
* Severe concomitant illness that would in the Investigator's opinion inhibit the participant'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:
* a. Serum creatinine \> 1.6 milligrams per deciliter (mg/dL) (141 micromole per liter \[mcmol/L\]) in female participants and \> 1.9 mg/dL (168 mcmol/L) in male participants;
* b. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 × upper limit of normal (ULN);
* c. Platelet count \< 100\*10\^9/L;
* d. Haemoglobin (Hb): Male \< 13.5 g/dL and Female \<12 g/dL;
* e. White blood cell count (WBCC) \< 3.0\*10\^9/L;
* f. Absolute neutrophil count \< 2.0\*10\^9/L;
* g. Absolute lymphocyte count \< 0.5\*10\^9/L;
* h. Total bilirubin \> ULN.
* Participation in any other clinical study, including non-interventional studies.

Primary outcomes:
measure: Percentage change in Eczema Area and Severity Index (EASI)
timeFrame: Baseline to day 113
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Baseline to day 113
Secondary outcomes:
measure: Percentage and absolute change from Baseline in EASI over time
timeFrame: Baseline to day 113
measure: Change in epidermal thickness
timeFrame: Baseline to day 113
measure: Change in keratin 16 staining of skin biopsies
timeFrame: Baseline to day 113
measure: Percentage of patients with at least a 50% reduction in EASI (EASI 50)
timeFrame: Baseline to day 113
measure: Percentage of patients with at least a 75% reduction in EASI (EASI 75)
timeFrame: Baseline to day 113
measure: Percentage of patients with at least a 90% reduction in EASI (EASI 90)
timeFrame: Baseline to day 113
measure: Change in Validated Investigator Global Assessment (vIGA)
timeFrame: Baseline to day 113
measure: Percentage of patients with a response of vIGA 0 or 1
timeFrame: Baseline to day 113
measure: Change in SCORing of Atopic Dermatis (SCORAD) Index
timeFrame: Baseline to day 113
measure: Change in affected body surface area (BSA)
timeFrame: Baseline to day 113
measure: Change in Patient Orientated Eczema Measure (POEM)
timeFrame: Baseline to Day 113
measure: Change in Patient Orientated SCORing of Atopic Dermatitis (PO-SCORAD) Index
timeFrame: Baseline to day 113
measure: Change in Dermatology Quality of Life Index (DLQI)
timeFrame: Baseline to Day 113
measure: Change in Numerical Rating Scale (NRS) for pruritus
timeFrame: Baseline to day 113
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Kymab investigational site 106
city: Leipzig
country: Germany
facility: Kymab investigational site 113
city: Gdansk
country: Poland
facility: Kymab investigational site 207
city: Katowice
country: Poland
facility: Kymab investigational site 216
city: Krakow
country: Poland
facility: Kymab investigational site 206
city: Kraków
country: Poland
facility: Kymab investigational site 212
city: Kraków
country: Poland
facility: Kymab investigational site 213
city: Kraków
country: Poland
facility: Kymab investigational site 214
city: Olsztyn
country: Poland
facility: Kymab investigational site 203
city: Poznań
country: Poland
facility: Kymab investigational site 210
city: Rzeszow
country: Poland
facility: Kymab investigator site 201
city: Warsaw
country: Poland
facility: Kymab investigational site 204
city: Wroclaw
country: Poland
facility: Kymab investigational site 202
city: Córdoba
country: Spain
facility: Kymab investigational site 304
city: Madrid
country: Spain
facility: Kymab investigational site 303
city: Seville
country: Spain
facility: Kymab investigational site 302
city: Valencia
country: Spain
facility: Kymab investigational site 315
city: Harrogate
country: United Kingdom
facility: Kymab investigational site 420
city: Sheffield
country: United Kingdom
facility: Kymab investigational site 402
Study officials:
affiliation: University Hospital Schleswig-Holstein, 24105 Kiel, Germany
name: Stephan Weidinger, MaHM
role: PRINCIPAL_INVESTIGATOR
References: