Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study
- Registration Number
- NCT05131477
- Lead Sponsor
- Kymab Limited
- Brief Summary
This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 5-arm study to assess the effect of Anti-OX40L Monoclonal Antibody (KY1005) in adult participants with moderate to severe atopic dermatitis.
The estimated duration is 28 days for screening and then up to approximately day 477 (last dose no later than day 337+140 days safety follow-up) for all patients unless enrolled into the LTE (Long-Term Extension) protocol (NCT05492578) at either Day 169 depending on responder status or no later than Day 365 due to loss of clinical response.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 390
- Adults (18 to < 75 years of age) with AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at Baseline.
- EASI of 12 or higher at the Screening Visit and 16 or higher at Baseline.
- IGA 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 visits 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.
- 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 clinically significant laboratory results from the clinical chemistry, hematology 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Every 4 weeks KY1005 Dose Level 1 KY1005 Every 4 weeks KY1005 Dose Level 2 KY1005 Every 4 weeks KY1005 Dose Level 3 KY1005 Every 4 weeks KY1005 Dose Level 4 KY1005 Every 4 weeks
- Primary Outcome Measures
Name Time Method Percentage change in EASI (Eczema Area and Severity Index) from Baseline Baseline to Day 113 The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.
- Secondary Outcome Measures
Name Time Method Percentage of patients with at least a 75% reduction from Baseline in EASI (EASI 75) 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.
Percentage of patients with a response of IGA (Investigator Global Assessment) 0 or 1 and a reduction from baseline ≥ 2 points 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.
Proportion of patients with improvement (reduction) of weekly average of pruritus NRS (Numerical Rating Scale) ≥ 4 with a baseline pruritus of ≥ 4 from baseline 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'.
Absolute and Percentage change in Dermatology Life Quality Index (DLQI) from Baseline 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.
Serum KY1005 concentration assessed throughout the study Baseline through Day 477 Incidence of treatment-emergent adverse event Baseline through Day 477 Change in IGA (Investigator Global Assessment) from Baseline 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
Percentage of patients with a score of IGA (Investigator Global Assessment) 0 or 1 and a reduction from Baseline of ≥ 2 points At Days 15, 29, 57, 85, and 141 The IGA is a five-point scale that provides a global clinical assessment of AD (Atopic Dermatitis) severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
Absolute and Percentage change in SCORAD (SCORing Atopic Dermatitis) Index from Baseline 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)
Absolute and Percentage change in Patient Oriented Eczema Measure (POEM) from Baseline 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
Absolute and Percentage change in weekly average of pruritus Numerical Rating Scale (NRS) from Baseline 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'.
Proportion of patients with improvement (reduction) of weekly average of pruritus NRS (Numerical Rating Scale) ≥ 3 with a baseline pruritus NRS ≥ 3 from baseline 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'.
Percentage change in EASI (Eczema Area and Severity Index) from baseline to Day 169 Baseline to Day 169 The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.
Absolute change from Baseline in EASI (Eczema Area and Severity Index) 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.
Percentage change from Baseline in EASI (Eczema Area and Severity Index) 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.
Percentage of patients with at least a 50% reduction from Baseline in EASI (EASI 50) 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.
Percentage of patients with at least a 90% reduction from Baseline in EASI (EASI 90) 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.
Percentage of patients with a 100% reduction from Baseline in EASI (EASI 100) 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.
Absolute and Percentage change in affected BSA from Baseline Baseline to Day 169 and over time up to Day 365 Absolute and Percentage change in Hospital Anxiety and Depression Scale (HADS) from Baseline 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
Incidence of positive anti-Ky1005 antibody response Baseline through Day 477 Time to loss of IGA 0/1 (Patients with a response of 0 or 1 in IGA) 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.
Absolute and Percentage change in Atopic Dermatitis Control Tool (ADCT) from Baseline 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
Time to loss of EASI 75 Week 24 to Day 365 The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition.
Time to loss of EASI 50 Week 24 to Day 365 The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition.
Trial Locations
- Locations (101)
Investigative Site Number: 1007
🇺🇸Miami, Florida, United States
Investigative site #2420
🇵🇱Łódź, Poland
Investigative Site Number: 1014
🇺🇸Beverly, Massachusetts, United States
Investigative Site Number: 1001
🇺🇸Clearwater, Florida, United States
Investigative Site Number: 1015
🇺🇸Indianapolis, Indiana, United States
Investigative Site Number: 1010
🇺🇸Clarksville, Indiana, United States
Investigative Site Number: 1008
🇺🇸Murfreesboro, Tennessee, United States
Investigative site #1023
🇺🇸Mansfield, Texas, United States
Investigative Site Number: 1106
🇨🇦Markham, Ontario, Canada
Investigative Site Number: 1021
🇺🇸Louisville, Kentucky, United States
Investigative Site Number: 1101
🇨🇦Windsor, Ontario, Canada
Investigative Site Number: 1005
🇺🇸Tulsa, Oklahoma, United States
Investigative site #1108
🇨🇦Niagara Falls, Ontario, Canada
Investigative Site Number: 3110
🇯🇵Sakai-Shi, Ôsaka, Japan
Investigative Site Number: 2417
🇵🇱Wrocław, Dolnoslaskie, Poland
Investigative Site Number: 2105
🇨🇿Nový Jicín, Moravskoslezský Kraj, Czechia
Investigative Site Number: 1004
🇺🇸Savannah, Georgia, United States
Investigative Site Number: 1003
🇺🇸Anderson, South Carolina, United States
Investigative Site Number: 2401
🇵🇱Rzeszów, Podkarpackie, Poland
Investigative site #2419
🇵🇱Białystok, Poland
Investigative Site Number: 2404
🇵🇱Gdynia, Pomorskie, Poland
Investigative Site Number: 2410
🇵🇱Szczecin, Zachodniopomorskie, Poland
Investigative Site Number: 1018
🇺🇸Fremont, California, United States
Investigative Site Number: 2103
🇨🇿Praha, Praha, Hlavní Mesto, Czechia
Investigative Site Number: 2001
🇧🇬Stara Zagora, Bulgaria
Investigative Site Number: 1017
🇺🇸Portland, Oregon, United States
Investigative Site Number: 2503
🇪🇸Madrid, Spain
Investigative Site Number: 2414
🇵🇱Wrocław, Dolnoslaskie, Poland
Investigative Site Number: 2416
🇵🇱Łódź, Lodzkie, Poland
Investigative Site Number: 2411
🇵🇱Warszawa, Mazowieckie, Poland
Investigative Site Number: 2405
🇵🇱Katowice, Slaskie, Poland
Investigative Site Number: 2403
🇵🇱Gdańsk, Poland
Investigative Site Number: 2601
🇬🇧London, United Kingdom
Investigational Site Number: 3001
🇦🇺Parkville, Australia
Investigative site #3101
🇯🇵Sapporo, Japan
Investigative Site Number: 2504
🇪🇸Pontevedra, Spain
Investigative Site Number: 2418
🇵🇱Wrocław, Dolnoslaskie, Poland
Investigative Site Number: 2004
🇧🇬Pleven, Bulgaria
Investigative Site Number: 3109
🇯🇵Habikino-Shi, Ôsaka, Japan
Investigative Site Number: 3201
🇨🇳Niao Song Qu, Taiwan
Investigative Site Number: 2415
🇵🇱Lódz, Lódzkie, Poland
Investigative Site Number: 3106
🇯🇵Mibu-machi, Japan
Investigative Site Number: 3202
🇨🇳Taichung, Taiwan
Investigative Site Number: 3203
🇨🇳Taoyuan, Taiwan
Investigative Site Number: 2402
🇵🇱Gdańsk, Pomorskie, Poland
Investigative Site Number: 2409
🇵🇱Kraków, Malopolskie, Poland
Investigative Site Number: 2413
🇵🇱Warszawa, Mazowieckie, Poland
Investigative Site Number: 2502
🇪🇸Manises, Valencia, Spain
Investigative Site Number: 2208
🇩🇪Kiel, Schleswig-Holstein, Germany
Investigative Site Number: 3104
🇯🇵Edagowa-Ku, Tokyo, Japan
Investigative Site Number: 3115
🇯🇵Chuo Ku, Tokyo, Japan
Investigative site #3105
🇯🇵Setagaya-Ku, Tokyo, Japan
Investigative site # 3206
🇨🇳Taipei, Taiwan
Investigative Site Number: 3111
🇯🇵Koto-Ku, Tokyo, Japan
Investigative Site Number: 1009
🇺🇸Portland, Oregon, United States
Investigative Site Number: 1013
🇺🇸Tampa, Florida, United States
Investigative site #1022
🇺🇸Sacramento, California, United States
Investigative Site Number: 1006
🇺🇸Boca Raton, Florida, United States
Investigative Site Number: 1011
🇺🇸Towson, Maryland, United States
Investigative Site Number: 1019
🇺🇸Coral Gables, Florida, United States
Investigative Site Number: 1012
🇺🇸Troy, Michigan, United States
Investigative Site Number 3002
🇦🇺Carlton, Australia
Investigative Site Number: 3003
🇦🇺East Melbourne, Australia
Investigative Site Number: 2005
🇧🇬Sofia, Bulgaria
Investigative Site Number: 2003
🇧🇬Sofia, Bulgaria
Investigative Site Number: 2006
🇧🇬Sofia, Bulgaria
Investigative Site Number: 2002
🇧🇬Sofia, Bulgaria
Investigative Site Number: 1103
🇨🇦Ottawa, Ontario, Canada
Investigative Site Number: 1107
🇨🇦Waterloo, Ontario, Canada
Investigative Site Number: 2108
🇨🇿Brno, Jihomoravský Kraj, Czechia
Investigative Site Number: 2106
🇨🇿Kutná Hora, Czechia
Investigative Site Number: 2104
🇨🇿Ostrava, Czechia
Investigative Site Number: 2102
🇨🇿Praha, Praha, Hlavní Mesto, Czechia
Investigative Site Number: 2209
🇩🇪Erlangen, Bayern, Germany
Investigative Site Number: 2202
🇩🇪Blankenfelde, Brandenburg, Germany
Investigator Site Number: 2201
🇩🇪Münster, Nordrhein-Westfalen, Germany
Investigative Site Number: 2203
🇩🇪Berlin, Germany
Investigative Site Number: 2301
🇭🇺Szeged, Csongrád, Hungary
Investigative Site Number: 2204
🇩🇪Hamburg, Germany
Investigative Site Number: 2307
🇭🇺Kecskemét, Bács-Kiskun, Hungary
Investigative Site Number: 2306
🇭🇺Szolnok, Jász-Nagykun-Szolnok, Hungary
Investigative Site Number: 2305
🇭🇺Gyula, Békés, Hungary
Investigative Site Number: 2303
🇭🇺Debrecen, Hajdú-Bihar, Hungary
Investigative Site Number: 2302
🇭🇺Zalaegerszeg, Zala, Hungary
Investigative Site Number: 2304
🇭🇺Budapest, Hungary
Investigative site #3113
🇯🇵Yokohama-Shi, Kanagawa, Japan
Investigative Site Number: 3114
🇯🇵Obihiro-Shi, Hokkaidô, Japan
Investigative site #3108
🇯🇵Kagoshima-Shi, Kagosima, Japan
Investigative Site Number: 3103
🇯🇵Matsudo, Tiba, Japan
Investigative Site Number: 3112
🇯🇵Adachi-Ku, Tokyo, Japan
Investigative Site Number: 3107
🇯🇵Minato-Ku, Tokyo, Japan
Investigative site #3102
🇯🇵Kyoto-Shi, Japan
Investigative Site Number: 2407
🇵🇱Kraków, Malopolskie, Poland
Investigative Site Number: 2420
🇵🇱Łódź, Lódzkie, Poland
Investigative Site Number: 2412
🇵🇱Warszawa, Mazowieckie, Poland
Investigative Site Number: 2406
🇵🇱Krakow, Poland
Investigative Site Number: 2505
🇪🇸Alicante, Spain
Investigative Site Number: 2501
🇪🇸Córdoba, Spain
Investigative Site Number: 2602
🇬🇧Sheffield, United Kingdom
Investigative Site Number: 2603
🇬🇧London, United Kingdom
Investigative Site Number: 2408
🇵🇱Kraków, Malopolskie, Poland