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

Sponsor
Kymab Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT03754309
Collaborator
(none)
89
Enrollment
19
Locations
3
Arms
21.8
Actual Duration (Months)
4.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
89 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Primary analysis up to day 113. Long term follow up to day 253 (dependent on response).Primary analysis up to day 113. Long term follow up to day 253 (dependent on response).
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 13, 2018
Actual Primary Completion Date :
May 12, 2020
Actual Study Completion Date :
Oct 8, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: KY1005 lower dose

Low dose KY1005

Drug: KY1005
A human anti-OX40 ligand monoclonal antibody
Experimental: KY1005 higher dose

High dose KY1005

Drug: KY1005
A human anti-OX40 ligand monoclonal antibody
Placebo Comparator: Placebo

Matched placebo

Drug: Placebo
Matched placebo

Outcome Measures

Primary Outcome Measures

  1. Percentage change in Eczema Area and Severity Index (EASI) [Baseline to day 113]

  2. Incidence of treatment-emergent adverse events (TEAEs) [Baseline to day 113]

Secondary Outcome Measures

  1. Percentage and absolute change from Baseline in EASI over time [Baseline to day 113]

  2. Change in epidermal thickness [Baseline to day 113]

  3. Change in keratin 16 staining of skin biopsies [Baseline to day 113]

  4. Percentage of patients with at least a 50% reduction in EASI (EASI 50) [Baseline to day 113]

  5. Percentage of patients with at least a 75% reduction in EASI (EASI 75) [Baseline to day 113]

  6. Percentage of patients with at least a 90% reduction in EASI (EASI 90) [Baseline to day 113]

  7. Change in Validated Investigator Global Assessment (vIGA) [Baseline to day 113]

  8. Percentage of patients with a response of vIGA 0 or 1 [Baseline to day 113]

  9. Change in SCORing of Atopic Dermatis (SCORAD) Index [Baseline to day 113]

  10. Change in affected body surface area (BSA) [Baseline to day 113]

  11. Change in Patient Orientated Eczema Measure (POEM) [Baseline to Day 113]

  12. Change in Patient Orientated SCORing of Atopic Dermatitis (PO-SCORAD) Index [Baseline to day 113]

  13. Change in Dermatology Quality of Life Index (DLQI) [Baseline to Day 113]

  14. Change in Numerical Rating Scale (NRS) for pruritus [Baseline to day 113]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Adults (≥ 18 years but < 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)).

  • EASI of 12 or higher at the Screening Visit and 16 or higher at Baseline.

  • vIGA of 3 or 4 at Baseline.

  • AD involvement of 10 percent or more of BSA 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 moisturiser, 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 patient'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:

    1. Serum creatinine > 1.6 mg/dL (141 μmol/L) in female patients and > 1.9 mg/dL (168 μmol/L) in male patients;
    1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × upper limit of normal (ULN);
    1. Platelet count < 100 × 10^9/L;
    1. Haemoglobin (Hb): Male < 13.5g/dL and Female <12g/dL;
    1. White blood cell count (WBCC) < 3.0 × 10^9/L;
    1. Absolute neutrophil count < 2.0 × 10^9/L;
    1. Absolute lymphocyte count < 0.5 × 10^9/L;
    1. Total bilirubin > ULN.

  • Participation in any other clinical study, including non-interventional studies.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kymab investigational site 106 Kiel Germany
2 Kymab investigational site 113 Leipzig Germany
3 Kymab investigational site 207 Gdansk Poland
4 Kymab investigational site 216 Katowice Poland
5 Kymab investigational site 206 Krakow Poland
6 Kymab investigational site 212 Kraków Poland
7 Kymab investigational site 213 Kraków Poland
8 Kymab investigational site 214 Kraków Poland
9 Kymab investigational site 203 Olsztyn Poland
10 Kymab investigational site 210 Poznań Poland
11 Kymab investigator site 201 Rzeszow Poland
12 Kymab investigational site 204 Warsaw Poland
13 Kymab investigational site 202 Wroclaw Poland
14 Kymab investigational site 304 Córdoba Spain
15 Kymab investigational site 303 Madrid Spain
16 Kymab investigational site 302 Seville Spain
17 Kymab investigational site 315 Valencia Spain
18 Kymab investigational site 420 Harrogate United Kingdom
19 Kymab investigational site 402 Sheffield United Kingdom

Sponsors and Collaborators

  • Kymab Limited

Investigators

  • Principal Investigator: Stephan Weidinger, MaHM, University Hospital Schleswig-Holstein, 24105 Kiel, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kymab Limited
ClinicalTrials.gov Identifier:
NCT03754309
Other Study ID Numbers:
  • KY1005-CT02
  • 2018-002299-41
First Posted:
Nov 27, 2018
Last Update Posted:
May 4, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis

Study Results

No Results Posted as of May 4, 2021