KY1005 for Eczema

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Eczema+3 More
KY1005 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying the effect of Anti-OX40L Monoclonal Antibody (KY1005) in adult participants with moderate to severe atopic dermatitis.

Eligible Conditions
  • Eczema
  • Dermatitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Eczema

Study Objectives

1 Primary · 30 Secondary · Reporting Duration: At Days 15, 29, 57, 85, 113, 141 and 169

Day 113
Percentage of patients with a response of IGA (Investigator Global Assessment) 0 or 1 and a reduction from baseline ≥ 2 points
Day 15
Percentage change from Baseline in EASI (Eczema Area and Severity Index)
Percentage change from Baseline in EASI (Eczema Area and Severity Index) At Days 15, 29, 57, 85 and 141
Day 15
Absolute change from Baseline in EASI (Eczema Area and Severity Index)
Percentage of patients with a 100% reduction from Baseline in EASI (EASI 100)
Percentage of patients with at least a 100% reduction from Baseline in EASI (EASI 100)
Percentage of patients with at least a 50% reduction from Baseline in EASI (EASI 50)
Percentage of patients with at least a 90% reduction from Baseline in EASI (EASI 90)
Day 15
Percentage of patients with a score of IGA (Investigator Global Assessment) 0 or 1 and a reduction from Baseline of ≥ 2 points
Percentage of patients with at least a 75% reduction from Baseline in EASI (EASI 75)
Response rate of patients who reach at least a 75% reduction from Baseline in EASI (EASI 75)
Response rate of patients with a score of IGA (Investigator Global Assessment) 0 or 1 and a reduction from Baseline of ≥ 2 points
Baseline through Day 477
Incidence of positive anti-Ky1005 antibody response
Incidence of treatment-emergent adverse event
Serum KY1005 concentration assessed throughout the study
Baseline to Day 113
Percentage change in EASI (Eczema Area and Severity Index) from Baseline
Baseline to Day 169
Percentage change in EASI (Eczema Area and Severity Index) from baseline to Day 169
Day 365
Absolute and Percentage change in Atopic Dermatitis Control Tool (ADCT) from Baseline
Absolute and Percentage change in Dermatology Life Quality Index (DLQI) from Baseline
Absolute and Percentage change in Hospital Anxiety and Depression Scale (HADS) from Baseline
Absolute and Percentage change in Patient Oriented Eczema Measure (POEM) from Baseline
Absolute and Percentage change in SCORAD (SCORing Atopic Dermatitis) Index from Baseline
Absolute and Percentage change in affected BSA from Baseline
Absolute and Percentage change in weekly average of pruritus Numerical Rating Scale (NRS) from Baseline
Day 113
Proportion of patients with improvement (reduction) of weekly average of pruritus NRS (Numerical Rating Scale) ≥ 3 with a baseline pruritus NRS ≥ 3 from baseline
Day 365
Change in IGA (Investigator Global Assessment) from Baseline
Day 365
Change from baseline in IGA (Investigator Global Assessment)
Days 113 and 169
Proportion of patients with improvement (reduction) of weekly average of pruritus NRS (Numerical Rating Scale) ≥ 4 with a baseline pruritus of ≥ 4 from baseline
Week 24
Time to loss of EASI 50
Time to loss of EASI 75
Time to loss of IGA 0/1 (Patients with a response of 0 or 1 in IGA)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Eczema

Trial Design

5 Treatment Groups

KY1005 Dose Level 1
1 of 5
KY1005 Dose Level 4
1 of 5
KY1005 Dose Level 2
1 of 5
KY1005 Dose Level 3
1 of 5
Placebo
1 of 5
Experimental Treatment
Non-Treatment Group

390 Total Participants · 5 Treatment Groups

Primary Treatment: KY1005 · Has Placebo Group · Phase 2

KY1005 Dose Level 1
Drug
Experimental Group · 1 Intervention: KY1005 · Intervention Types: Drug
KY1005 Dose Level 4
Drug
Experimental Group · 1 Intervention: KY1005 · Intervention Types: Drug
KY1005 Dose Level 2
Drug
Experimental Group · 1 Intervention: KY1005 · Intervention Types: Drug
KY1005 Dose Level 3
Drug
Experimental Group · 1 Intervention: KY1005 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KY1005
2017
Completed Phase 2
~180

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at days 15, 29, 57, 85, 113, 141 and 169

Who is running the clinical trial?

SanofiIndustry Sponsor
2,029 Previous Clinical Trials
2,907,979 Total Patients Enrolled
35 Trials studying Eczema
13,408 Patients Enrolled for Eczema
Kymab LimitedLead Sponsor
4 Previous Clinical Trials
457 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have applied a stable dose of topical bland emollient (simple moisturizer, no additives [e.g., urea]) at least twice daily for a minimum of 7 consecutive days before Baseline.
You have at least 1 year of clinical experience in the treatment of AD.
You have EASI scores of 12 or higher at the Screening Visit and 16 or higher at Baseline.
You have a body surface area of 10% or more of your BSA at baseline.
You are able and willing to comply with requested study visits/telephone visits and procedures.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 14th, 2021

Last Reviewed: October 23rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.