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

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ClinicalTrials.gov Identifier: NCT03754309
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Kymab Limited

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
Dermatitis, Atopic Drug: KY1005 Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Primary analysis up to day 113. Long term follow up to day 365 (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 : December 13, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




Primary Outcome Measures :
  1. Percentage change in Eczema Area and Severity Index (EASI) [ Time Frame: Baseline to day 113 ]
  2. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline to day 113 ]

Secondary Outcome Measures :
  1. Percentage and absolute change from Baseline in EASI over time [ Time Frame: Baseline to day 113 ]
  2. Change in epidermal thickness [ Time Frame: Baseline to day 113 ]
  3. Change in keratin 16 staining of skin biopsies [ Time Frame: Baseline to day 113 ]
  4. Percentage of patients with at least a 50% reduction in EASI (EASI 50) [ Time Frame: Baseline to day 113 ]
  5. Percentage of patients with at least a 75% reduction in EASI (EASI 75) [ Time Frame: Baseline to day 113 ]
  6. Percentage of patients with at least a 90% reduction in EASI (EASI 90) [ Time Frame: Baseline to day 113 ]
  7. Change in Validated Investigator Global Assessment (vIGA) [ Time Frame: Baseline to day 113 ]
  8. Percentage of patients with a response of vIGA 0 or 1 [ Time Frame: Baseline to day 113 ]
  9. Change in SCORing of Atopic Dermatis (SCORAD) Index [ Time Frame: Baseline to day 113 ]
  10. Change in affected body surface area (BSA) [ Time Frame: Baseline to day 113 ]
  11. Change in Patient Orientated Eczema Measure (POEM) [ Time Frame: Baseline to Day 113 ]
  12. Change in Patient Orientated SCORing of Atopic Dermatitis (PO-SCORAD) Index [ Time Frame: Baseline to day 113 ]
  13. Change in Dermatology Quality of Life Index (DLQI) [ Time Frame: Baseline to Day 113 ]
  14. Change in Numerical Rating Scale (NRS) for pruritus [ Time Frame: Baseline to day 113 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:
  • a. Serum creatinine > 1.6 mg/dL (141 μmol/L) in female patients and > 1.9 mg/dL (168 μmol/L) in male patients;
  • 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 < 13.5g/dL and Female <12g/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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754309


Contacts
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Contact: Kymab Ltd +44 (0)1223 833301 clinicaltrial@kymab.com

Locations
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Germany
Kymab investigational site Not yet recruiting
Bonn, Germany
Contact: Kymab investigator         
Kymab investigational site 103 Not yet recruiting
Hannover, Germany
Contact: Kymab investigator         
Kymab investigational site 106 Recruiting
Kiel, Germany
Contact: Kymab investigator         
Kymab investigational site 113 Not yet recruiting
Leipzig, Germany
Contact: Kymab investigator         
Kymab investigational site 102 Not yet recruiting
Lubeck, Germany
Contact: Kymab investigator         
Kymab investigational site Not yet recruiting
Munich, Germany
Contact: Kymab investigator         
Poland
Kymab investigational site 207 Recruiting
Gdansk, Poland
Contact: Kymab investigator         
Kymab investigational site 206 Recruiting
Krakow, Poland
Contact: Kymab investigator         
Kymab investigational site 203 Recruiting
Olsztyn, Poland
Contact: Kymab investigator         
Kymab investigator site 201 Recruiting
Rzeszow, Poland
Contact: Kymab investigator         
Kymab investigational site 204 Recruiting
Warsaw, Poland
Contact: Kymab investigator         
Kymab investigational site 202 Recruiting
Wroclaw, Poland
Contact: Kymab investigator         
Spain
Kymab investigational site 304 Recruiting
Córdoba, Spain
Contact: Kymab investigator         
Kymab investigational site 303 Recruiting
Madrid, Spain
Contact: Kymab investigator         
Kymab investigational site 302 Recruiting
Seville, Spain
Contact: Kymab investigator         
Kymab investigational site 315 Recruiting
Valencia, Spain
Contact: Kymab investigator         
United Kingdom
Kymab investigational site 420 Not yet recruiting
Harrogate, United Kingdom
Contact: Kymab investigator         
Kymab investigational site 402 Recruiting
Sheffield, United Kingdom
Contact: Kymab investigator         
Sponsors and Collaborators
Kymab Limited
Investigators
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Principal Investigator: Stephan Weidinger, MaHM University Hospital Schleswig-Holstein, 24105 Kiel, Germany

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Responsible Party: Kymab Limited
ClinicalTrials.gov Identifier: NCT03754309     History of Changes
Other Study ID Numbers: KY1005-CT02
2018-002299-41 ( EudraCT Number )
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs