A Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03754309
• Other study ID #: KY1005-CT02
• Secondary ID: 2018-002299-41AC
• Status: Completed
• Phase: Phase 2
• Start date: December 13, 2018
• Est. completion date: October 8, 2020

Study information

• Verified date: January 2023
• Source: Kymab Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: October 8, 2020
• Est. primary completion date: May 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Drug:
• KY1005
A human anti-OX40 ligand monoclonal antibody
• Placebo
Matched placebo

Locations

Country	Name	City	State
Germany	Kymab investigational site 106	Kiel
Germany	Kymab investigational site 113	Leipzig
Poland	Kymab investigational site 207	Gdansk
Poland	Kymab investigational site 216	Katowice
Poland	Kymab investigational site 206	Krakow
Poland	Kymab investigational site 212	Kraków
Poland	Kymab investigational site 213	Kraków
Poland	Kymab investigational site 214	Kraków
Poland	Kymab investigational site 203	Olsztyn
Poland	Kymab investigational site 210	Poznan
Poland	Kymab investigator site 201	Rzeszow
Poland	Kymab investigational site 204	Warsaw
Poland	Kymab investigational site 202	Wroclaw
Spain	Kymab investigational site 304	Córdoba
Spain	Kymab investigational site 303	Madrid
Spain	Kymab investigational site 302	Seville
Spain	Kymab investigational site 315	Valencia
United Kingdom	Kymab investigational site 420	Harrogate
United Kingdom	Kymab investigational site 402	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Kymab Limited

Countries where clinical trial is conducted

Germany,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in Eczema Area and Severity Index (EASI)		Baseline to day 113
Primary	Incidence of treatment-emergent adverse events (TEAEs)		Baseline to day 113
Secondary	Percentage and absolute change from Baseline in EASI over time		Baseline to day 113
Secondary	Change in epidermal thickness		Baseline to day 113
Secondary	Change in keratin 16 staining of skin biopsies		Baseline to day 113
Secondary	Percentage of patients with at least a 50% reduction in EASI (EASI 50)		Baseline to day 113
Secondary	Percentage of patients with at least a 75% reduction in EASI (EASI 75)		Baseline to day 113
Secondary	Percentage of patients with at least a 90% reduction in EASI (EASI 90)		Baseline to day 113
Secondary	Change in Validated Investigator Global Assessment (vIGA)		Baseline to day 113
Secondary	Percentage of patients with a response of vIGA 0 or 1		Baseline to day 113
Secondary	Change in SCORing of Atopic Dermatis (SCORAD) Index		Baseline to day 113
Secondary	Change in affected body surface area (BSA)		Baseline to day 113
Secondary	Change in Patient Orientated Eczema Measure (POEM)		Baseline to Day 113
Secondary	Change in Patient Orientated SCORing of Atopic Dermatitis (PO-SCORAD) Index		Baseline to day 113
Secondary	Change in Dermatology Quality of Life Index (DLQI)		Baseline to Day 113
Secondary	Change in Numerical Rating Scale (NRS) for pruritus		Baseline to day 113