Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study (STREAM-AD)

JRCT ID: jRCT2011210072

Registered date:09/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 08/06/2022
• Target sample size: 350
• Countries of recruitment: Australia,Japan,Bulgaria,Japan,Canada,Japan,Czechia,Japan,Germany,Japan,Hungary,Japan,Poland,Japan,Spain,Japan,Taiwan,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: KY1005
Pharmaceutical Form: Injection solution, Route of Administration: Subcutaneous
Drug: Placebo
Pharmaceutical Form: Injection solution,Route of Administration: Subcutaneous

Outcome(s)

Primary Outcome

1. Percentage change in EASI (Eczema Area and Severity Index) from Baseline [ Time Frame: Baseline to Day 113 ]
The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.

Secondary Outcome

1. Incidence of treatment-emergent adverse event [ Time Frame: Baseline through Day 477 ]
2. Serum KY1005 concentration assessed throughout the study [ Time Frame: Baseline through Day 477 ]
3. Percentage change in EASI (Eczema Area and Severity Index) from baseline to Day 169 [ Time Frame: Baseline to Day 169 ]
The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.
4. Percentage of patients with at least a 75% reduction from Baseline in EASI (EASI 75) [ Time Frame: At Days 113 and 169 ]
The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.
5. Percentage of patients with a response of IGA (Investigator Global Assessment) 0 or 1 and a reduction from baseline >= 2 points [ Time Frame: At Days 113 and 169 ]
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe AD.
6. Proportion of patients with improvement (reduction) of weekly average of pruritus NRS (Numerical Rating Scale) >= 4 with a baseline pruritus of >= 4 from baseline [ Time Frame: Days 113 and 169 ]
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being <no itch> and 10 being the <worst itch imaginable> .
7. Absolute change from Baseline in EASI (Eczema Area and Severity Index) [ Time Frame: At Days 15, 29, 57, 85, 113, 141 and 169 ]
The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.
8. Percentage change from Baseline in EASI (Eczema Area and Severity Index) [ Time Frame: At Days 15, 29, 57, 85 and 141 ]
The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.
9. Percentage of patients with at least a 50% reduction from Baseline in EASI (EASI 50) [ Time Frame: At Days 15, 29, 57, 85, 113, 141 and 169 ]
The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.
10. Percentage of patients with at least a 75% reduction from Baseline in EASI (EASI 75) [ Time Frame: At Days 15, 29, 57, 85, and 141 ]
The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.
11. Percentage of patients with at least a 90% reduction from Baseline in EASI (EASI 90) [ Time Frame: At Days 15, 29, 57, 85, 113, 141 and 169 ]
The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.
12. Percentage of patients with a 100% reduction from Baseline in EASI (EASI 100) [ Time Frame: At Days 15, 29, 57, 85, 113, 141 and 169 ]
The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.
13. Change in IGA (Investigator Global Assessment) from baselin [ Time Frame: Baseline to day 113 and over time up to Day 365 ]
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
14. Percentage of patients with a score of IGA (Investigator Global Assessment) 0 or 1 and a reduction from Baseline of >= 2 points [ Time Frame: At Days 15, 29, 57, 85, and 141 ]
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
15. Absolute and Percentage change in SCORAD (SCORing Atopic Dermatitis) Index from Baseline [ Time Frame: Baseline to Day 169 and over time up to Day 365 ]
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease).
16. Absolute and Percentage change in affected BSA from Baseline [ Time Frame: Baseline to Day 169 and over time up to Day 365 ]
17. Absolute and Percentage change in Patient Oriented Eczema Measure (POEM) from Baseline [ Time Frame: Baseline to Day 169 and over time up to Day 365 ]
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
18. Absolute and Percentage change in Dermatology Life Quality Index (DLQI) from Baseline [ Time Frame: Baseline to Day 169 and over time up to Day 365 ]
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL (Quality of life).
19. Absolute and Percentage change in Atopic Dermatitis Control Tool (ADCT) from Baseline [ Time Frame: Baseline to Day 169 and over time up to Day 365 ]
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
20. Absolute and Percentage change in Hospital Anxiety and Depression Scale (HADS) from Baseline [ Time Frame: Baseline to Day 169 and over time up to Day 365 ]
HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression
21. Absolute and Percentage change in weekly average of pruritus Numerical Rating Scale (NRS) from Baseline [ Time Frame: Baseline to Day 169 and over time up to Day 365 ]
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being <no itch> and 10 being the <worst itch imaginable> .
22. Proportion of patients with improvement (reduction) of weekly average of pruritus NRS (Numerical Rating Scale) >= 3 with a baseline pruritus NRS >= 3 from baseline [ Time Frame: Baseline to Days 113 and 169 ]
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being <no itch> and 10 being the <worst itch imaginable>.
23. Incidence of positive anti-Ky1005 antibody response [ Time Frame: Baseline through Day 477 ]
24. Time to loss of EASI 75 [ Time Frame: Week 24 to Day 365 ]
The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition.
25. Time to loss of IGA 0/1 (Patients with a response of 0 or 1 in IGA) [ Time Frame: Week 24 to Day 365 ]
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe AD.
26. Time to loss of EASI 50 [ Time Frame: Week 24 to Day 365 ]
The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

- Adults (18 to < 75 years of age) with AD (Atopic dermatitis) as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at Baseline.
- EASI (Eczema Area and Severity Index) of 12 or higher at the Screening Visit and 16 or higher at Baseline.
- IGA (Investigator Global Assessment) of 3 or 4 at Baseline.
- AD involvement of 10% or more of body surface area (BSA) at Baseline.
- Baseline worst / maximum pruritus NRS of >= 4.
- Documented history, within 6 months prior to Baseline, of either inadequate response 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 a minimum of 7 consecutive days before Baseline.
- Able to complete patient questionnaires
- Able and willing to comply with requested study visits / telephone and procedures.
- Able and willing to provide written informed consent.
- For patients who decide to join the biopsy sub-study be able and willing to provide skin biopsies.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Exclude criteria

- 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.
- Weight < 40 kg or > 150 kg at Baseline.
- Treatment with a live (attenuated) immunization within 12 weeks prior to Baseline.
- Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding.
- Any malignancies or history of malignancies prior to Baseline (except for non-melanoma skin cancer that has been excised and cured for more than 3 years prior to Baseline; in situ cervical carcinoma that has been excised and cured).
- Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at the screening visit.
-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, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease.
-In the Investigator's opinion, any additional clinically significant laboratory results from the clinical chemistry, haematology or urinalysis tests at the Screening Visit.
-Concurrent participation in any other clinical study, including non-interventional studies.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Information

• Primary Sponsor: Tanaka Tomoyuki
• Secondary ID(s): NCT05131477,2021-000725-28