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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Dec 2018

Geographic Reach

4 countries

19 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

November 19, 2018

Completed

8 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed

16 days until next milestone

Study Start

First participant enrolled

December 13, 2018

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2020

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2020

Completed

Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

1.4 years

First QC Date

November 19, 2018

Last Update Submit

January 25, 2023

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (2)

Percentage change in Eczema Area and Severity Index (EASI)
Baseline to day 113
Incidence of treatment-emergent adverse events (TEAEs)
Baseline to day 113

Secondary Outcomes (14)

Percentage and absolute change from Baseline in EASI over time
Baseline to day 113
Change in epidermal thickness
Baseline to day 113
Change in keratin 16 staining of skin biopsies
Baseline to day 113
Percentage of patients with at least a 50% reduction in EASI (EASI 50)
Baseline to day 113
Percentage of patients with at least a 75% reduction in EASI (EASI 75)
Baseline to day 113
+9 more secondary outcomes

Study Arms (3)

KY1005 lower dose

EXPERIMENTAL

Low dose KY1005

Drug: KY1005

KY1005 higher dose

EXPERIMENTAL

High dose KY1005

Drug: KY1005

Placebo

PLACEBO COMPARATOR

Matched placebo

Drug: Placebo

Interventions

KY1005DRUG

A human anti-OX40 ligand monoclonal antibody

Also known as: SAR445229

KY1005 higher doseKY1005 lower dose

PlaceboDRUG

Matched placebo

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Kymab Limitedlead

Study Sites (19)

Kymab investigational site 106

Kiel, Germany

Location

Kymab investigational site 113

Leipzig, Germany

Location

Kymab investigational site 207

Gdansk, Poland

Location

Kymab investigational site 216

Katowice, Poland

Location

Kymab investigational site 206

Krakow, Poland

Location

Kymab investigational site 212

Krakow, Poland

Location

Kymab investigational site 213

Krakow, Poland

Location

Kymab investigational site 214

Krakow, Poland

Location

Kymab investigational site 203

Olsztyn, Poland

Location

Kymab investigational site 210

Poznan, Poland

Location

Kymab investigator site 201

Rzeszów, Poland

Location

Kymab investigational site 204

Warsaw, Poland

Location

Kymab investigational site 202

Wroclaw, Poland

Location

Kymab investigational site 304

Córdoba, Spain

Location

Kymab investigational site 303

Madrid, Spain

Location

Kymab investigational site 302

Seville, Spain

Location

Kymab investigational site 315

Valencia, Spain

Location

Kymab investigational site 420

Harrogate, United Kingdom

Location

Kymab investigational site 402

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

Stephan Weidinger, MaHM
University Hospital Schleswig-Holstein, 24105 Kiel, Germany
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 27, 2018

Study Start

December 13, 2018

Primary Completion

May 12, 2020

Study Completion

October 8, 2020

Last Updated

January 27, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing: Will share

Locations

ES(4)DE(2)PL(11)GB(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (14)

Study Arms (3)

KY1005 lower dose

KY1005 higher dose

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (19)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations