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

A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Dose Ranging Study of a Subcutaneous Anti-OX40L Monoclonal Antibody (KY1005) in Moderate-to-Severe Atopic Dermatitis

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 Long-Term Extension (LTE) protocol (NCT05492578) at either Day 169 depending on responder status or no later than Day 365 due to loss of clinical response.

Study Overview

• Status: Completed
• Conditions: Eczema; Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: Amlitelimab

• Study Type: Interventional
• Enrollment (Actual): 390
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Carlton, Australia, 3053
    • Investigative Site Number 3002
  • East Melbourne, Australia, 3002
    • Investigative Site Number: 3003
  • Parkville, Australia, 3050
    • Investigational Site Number: 3001
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Investigative Site Number: 2004
  • Sofia, Bulgaria, 1431
    • Investigative Site Number: 2005
  • Sofia, Bulgaria, 1592
    • Investigative Site Number: 2006
  • Sofia, Bulgaria, 1612
    • Investigative Site Number: 2003
  • Sofia, Bulgaria, 1784
    • Investigative Site Number: 2002
  • Stara Zagora, Bulgaria, 6003
    • Investigative Site Number: 2001
• Canada
  • Ontario
    • Markham, Ontario, Canada, L3P 1X2
      • Investigative Site Number: 1106
    • Niagara Falls, Ontario, Canada, L2H 1H5
      • Investigative site #1108
    • Ottawa, Ontario, Canada, K2C 3N2
      • Investigative Site Number: 1103
    • Waterloo, Ontario, Canada, N2J 1C4
      • Investigative Site Number: 1107
    • Windsor, Ontario, Canada, N8W 1E6
      • Investigative Site Number: 1101
• Czechia
  • Kutná Hora, Czechia, 284 01
    • Investigative Site Number: 2106
  • Ostrava, Czechia, 702 00
    • Investigative Site Number: 2104
  • Jihomoravský Kraj
    • Brno, Jihomoravský Kraj, Czechia, 602 00
      • Investigative Site Number: 2108
  • Moravskoslezský Kraj
    • Nový Jicín, Moravskoslezský Kraj, Czechia, 741 01
      • Investigative Site Number: 2105
  • Praha, Hlavní Mesto
    • Praha, Praha, Hlavní Mesto, Czechia, 108 00
      • Investigative Site Number: 2102
    • Praha, Praha, Hlavní Mesto, Czechia, 130 00
      • Investigative Site Number: 2103
• Germany
  • Berlin, Germany, 10117
    • Investigative Site Number: 2203
  • Hamburg, Germany, 20251
    • Investigative Site Number: 2204
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • Investigative Site Number: 2209
  • Brandenburg
    • Blankenfelde, Brandenburg, Germany, 15827
      • Investigative Site Number: 2202
  • Nordrhein-Westfalen
    • Münster, Nordrhein-Westfalen, Germany, 48149
      • Investigator Site Number: 2201
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 2405
      • Investigative Site Number: 2208
• Hungary
  • Budapest, Hungary, 1036
    • Investigative Site Number: 2304
  • Bács-Kiskun
    • Kecskemét, Bács-Kiskun, Hungary, 6000
      • Investigative Site Number: 2307
  • Békés
    • Gyula, Békés, Hungary, 5700
      • Investigative Site Number: 2305
  • Csongrád
    • Szeged, Csongrád, Hungary, 6720
      • Investigative Site Number: 2301
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Investigative Site Number: 2303
  • Jász-Nagykun-Szolnok
    • Szolnok, Jász-Nagykun-Szolnok, Hungary, 5000
      • Investigative Site Number: 2306
  • Zala
    • Zalaegerszeg, Zala, Hungary, 8900
      • Investigative Site Number: 2302
• Japan
  • Kyoto-Shi, Japan, 602-0841
    • Investigative site #3102
  • Mibu-machi, Japan, 321-0293
    • Investigative Site Number: 3106
  • Sapporo, Japan, 060-0063
    • Investigative site #3101
  • Hokkaidô
    • Obihiro-Shi, Hokkaidô, Japan, 080-0013
      • Investigative Site Number: 3114
  • Kagosima
    • Kagoshima-Shi, Kagosima, Japan, 890-0063
      • Investigative site #3108
  • Kanagawa
    • Yokohama-Shi, Kanagawa, Japan, 221-0825
      • Investigative site #3113
  • Tiba
    • Matsudo, Tiba, Japan, 270-2223
      • Investigative Site Number: 3103
  • Tokyo
    • Adachi-Ku, Tokyo, Japan, 120-0034
      • Investigative Site Number: 3112
    • Chuo Ku, Tokyo, Japan
      • Investigative Site Number: 3115
    • Edagowa-Ku, Tokyo, Japan, 133-0052
      • Investigative Site Number: 3104
    • Koto-Ku, Tokyo, Japan, 136-0074
      • Investigative Site Number: 3111
    • Minato-Ku, Tokyo, Japan, 108-0014
      • Investigative Site Number: 3107
    • Setagaya-Ku, Tokyo, Japan, 158-0097
      • Investigative site #3105
  • Ôsaka
    • Habikino-Shi, Ôsaka, Japan, 583-0872
      • Investigative Site Number: 3109
    • Sakai-Shi, Ôsaka, Japan, 593-8324
      • Investigative Site Number: 3110
• Poland
  • Białystok, Poland, 15-879
    • Investigative site #2419
  • Gdańsk, Poland, 80-592
    • Investigative Site Number: 2403
  • Krakow, Poland, 31-559
    • Investigative Site Number: 2406
  • Łódź, Poland, 90-349
    • Investigative site #2420
  • Dolnoslaskie
    • Wrocław, Dolnoslaskie, Poland, 50-088
      • Investigative Site Number: 2414
    • Wrocław, Dolnoslaskie, Poland, 50-368
      • Investigative Site Number: 2418
    • Wrocław, Dolnoslaskie, Poland, 51-685
      • Investigative Site Number: 2417
  • Lodzkie
    • Łódź, Lodzkie, Poland, 90-436
      • Investigative Site Number: 2416
  • Lódzkie
    • Lódz, Lódzkie, Poland, 90-127
      • Investigative Site Number: 2415
    • Łódź, Lódzkie, Poland, 90-349
      • Investigative Site Number: 2420
  • Malopolskie
    • Kraków, Malopolskie, Poland, 30-033
      • Investigative Site Number: 2408
    • Kraków, Malopolskie, Poland, 30-510
      • Investigative Site Number: 2407
    • Kraków, Malopolskie, Poland, 31-011
      • Investigative Site Number: 2409
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 00-874
      • Investigative Site Number: 2412
    • Warszawa, Mazowieckie, Poland, 01-142
      • Investigative Site Number: 2411
    • Warszawa, Mazowieckie, Poland, 01-192
      • Investigative Site Number: 2413
  • Podkarpackie
    • Rzeszów, Podkarpackie, Poland, 35-055
      • Investigative Site Number: 2401
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-879
      • Investigative site #2419
  • Pomorskie
    • Gdańsk, Pomorskie, Poland, 80-382
      • Investigative Site Number: 2402
    • Gdynia, Pomorskie, Poland, 81-384
      • Investigative Site Number: 2404
  • Slaskie
    • Katowice, Slaskie, Poland, 40-040
      • Investigative Site Number: 2405
  • Zachodniopomorskie
    • Szczecin, Zachodniopomorskie, Poland, 71-434
      • Investigative Site Number: 2410
• Spain
  • Alicante, Spain, 3010
    • Investigative Site Number: 2505
  • Córdoba, Spain, 14004
    • Investigative Site Number: 2501
  • Madrid, Spain, 28046
    • Investigative Site Number: 2503
  • Pontevedra, Spain, 36001
    • Investigative Site Number: 2504
  • Valencia
    • Manises, Valencia, Spain, 46940
      • Investigative Site Number: 2502
• Taiwan
  • Niao Song Qu, Taiwan, 833
    • Investigative Site Number: 3201
  • Taichung, Taiwan, 402
    • Investigative Site Number: 3202
  • Taipei, Taiwan, 11217
    • Investigative site # 3206
  • Taipei, Taiwan, 112217
    • Investigative site # 3206
  • Taoyuan, Taiwan, 33305
    • Investigative Site Number: 3203
• United Kingdom
  • London, United Kingdom, E11 1NR
    • Investigative Site Number: 2603
  • London, United Kingdom, SE1 9RT
    • Investigative Site Number: 2601
  • Sheffield, United Kingdom, S10 2TF
    • Investigative Site Number: 2602
• United States
  • California
    • Fremont, California, United States, 94538-1601
      • Investigative Site Number: 1018
    • Sacramento, California, United States, 95816-3370
      • Investigative site #1022
  • Florida
    • Boca Raton, Florida, United States, 33428
      • Investigative Site Number: 1006
    • Clearwater, Florida, United States, 33756-3424
      • Investigative Site Number: 1001
    • Coral Gables, Florida, United States, 33134-2950
      • Investigative Site Number: 1019
    • Miami, Florida, United States, 33176-2264
      • Investigative Site Number: 1007
    • Tampa, Florida, United States, 33615-3816
      • Investigative Site Number: 1013
  • Georgia
    • Savannah, Georgia, United States, 31406-2668
      • Investigative Site Number: 1004
  • Indiana
    • Clarksville, Indiana, United States, 47129-2201
      • Investigative Site Number: 1010
    • Indianapolis, Indiana, United States, 46250-2041
      • Investigative Site Number: 1015
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Investigative Site Number: 1021
  • Maryland
    • Towson, Maryland, United States, 21204-7448
      • Investigative Site Number: 1011
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915-1666
      • Investigative Site Number: 1014
  • Michigan
    • Troy, Michigan, United States, 48084-3536
      • Investigative Site Number: 1012
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136-7049
      • Investigative Site Number: 1005
  • Oregon
    • Portland, Oregon, United States, 97223-6683
      • Investigative Site Number: 1017
    • Portland, Oregon, United States, 97239
      • Investigative Site Number: 1009
  • South Carolina
    • Anderson, South Carolina, United States, 29621-2062
      • Investigative Site Number: 1003
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130-2450
      • Investigative Site Number: 1008
  • Texas
    • Mansfield, Texas, United States, 76063
      • Investigative site #1023

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• Eczema Area and Severity Index (EASI) of 12 or higher at the Screening Visit and 16 or higher at Baseline.
• Investigator's Global Assessment (IGA) Scale of 3 or 4 at Baseline.
• AD involvement of 10% or more of body surface area (BSA) at Baseline.
• Baseline worst/maximum pruritus Numeric Rating Scale (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.

Exclusion 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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Every 4 weeks	Drug: Placebo; Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Experimental: 250mg (500mg Loading Dose) KY1005; Every 4 weeks	Drug: Amlitelimab; Pharmaceutical form: Injection solution Route of administration: Subcutaneous; Other Names: SAR445229; A human anti-OX40 ligand monoclonal antibody; KY1005
Experimental: 250mg (No Loading Dose) KY1005; Every 4 weeks	Drug: Amlitelimab; Pharmaceutical form: Injection solution Route of administration: Subcutaneous; Other Names: SAR445229; A human anti-OX40 ligand monoclonal antibody; KY1005
Experimental: 125mg KY1005; Every 4 weeks	Drug: Amlitelimab; Pharmaceutical form: Injection solution Route of administration: Subcutaneous; Other Names: SAR445229; A human anti-OX40 ligand monoclonal antibody; KY1005
Experimental: 62.5mg KY1005; Every 4 weeks	Drug: Amlitelimab; Pharmaceutical form: Injection solution Route of administration: Subcutaneous; Other Names: SAR445229; A human anti-OX40 ligand monoclonal antibody; KY1005

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1)	Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.	Baseline to week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1)	Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.	Baseline to week 24
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1)	Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.	Baseline to week 16 and week 24
Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1)	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,1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD.	Baseline to week 16 and week 24
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1)	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'.	Baseline to week 16 and week 24
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)	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'.	Baseline to weeks week 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)	Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.	Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)	Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.	Baseline to weeks 2,4, 8,12,16, 20 and 24
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)	Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.	Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)	Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.	Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)	Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.	Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)	Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.	Baseline at weeks 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)	Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.	Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)	Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.	Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1)	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, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD	Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
Change in IGA (Investigator Global Assessment) From Baseline (Part 2)	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, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD	Baseline to weeks 24, 28, 31, 36, 40, 44, 48 & 52
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1)	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, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD	Baseline to weeks 2, 4, 8,12,16,20 & 24
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)	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)	Baseline to weeks 4, 8, 12, 16, 20 & 24
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)	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)	Baseline to week 24, 28, 32, 36, 40, 44, 48 & 52
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)	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)	Baseline to weeks 4, 8, 12, 16, 20, & 24
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)	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)	Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)		Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
Absolute Change in Affected BSA From Baseline (Part 2)		Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Percentage Change in Affected BSA From Baseline (Part 1)		Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
Percentage Change in Affected BSA From Baseline (Part 2)		Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)	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	Baseline to weeks 4, 8, 12, 16, 20, & 24
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)	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	Baseline to weeks 24, 32, 36, 40, 44, 48 & 52
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)	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	Baseline to weeks 4, 8, 12, 16, 20, & 24
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)	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	Baseline to weeks 24, 32, 36, 40. 44, 48, & 52
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1)	DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.	Baseline to weeks 2, 8, 16, 20, & 24
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)	DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.	Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)	DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.	Baseline to weeks 2, 8, 16, 20, & 24
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)	DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.	Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)	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	Baseline to weeks 16, & 24
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)	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	Baseline to weeks 24, 36 & 52
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)	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	Baseline to weeks 16, & 24
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)	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	Baseline to weeks 24, 36 & 52
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)	The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.	Baseline to weeks 8 16, 20, & 24
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)	The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.	Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)	The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.	Baseline to weeks 8, 16, 20, & 24
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)	The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.	Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)	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'.	Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, & 24
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)	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'.	Baseline to weeks 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)	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'.	Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 & 24
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)	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'.	Baseline to weeks 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)	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'.	Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, & 24
Incidence Rate of Loss of EASI 50 (Part 2)	The incidence rate of loss of EASI 50 is calculated for participants who achieved EASI 50 at re-randomization (week 24). The incidence rate is computed as the number of participants losing EASI 50 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of EASI 50) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.	Week 24 to week 52
Incidence Rate of Loss of EASI 75 (Part 2)	The incidence rate of loss of EASI 75 is calculated for participants who achieved EASI 75 at re-randomization (week 24). The incidence rate is computed as the number of participants losing EASI 75 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of EASI 75) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.	Week 24 to week 52
Incidence Rate of Loss of IGA 0/1 (Part 2)	The incidence rate of loss of IGA 0/1 is calculated for participants who achieved IGA 0/1 at re-randomization (week 24). The incidence rate is computed as the number of participants losing IGA 0/1 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of IGA 0/1) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.	Week 24 to week 68
Serum KY1005 Concentration Assessed Throughout the Study (Part 1)		Baseline and at weeks 1, 2, 4, 8, 12, 16, 17, 20, & 24
Serum KY1005 Concentration Assessed Throughout the Study (Part 2)		Baseline and at weeks 24, 25, 28, 32, 36, 40, 44, 48, & 52
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1)		Baseline through week 24
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2)		Week 24 through week 68
Percentage of Participants With Treatment-emergent ADA (Part 1)		Baseline through week 24
Percentage of Participants With Treatment-emergent ADA (Part 2)		Baseline through week 68

Collaborators and Investigators

• Sponsor: Kymab Limited
• Collaborators: Sanofi

Publications and helpful links

Helpful Links

• DRI17366 Plain language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Actual): April 26, 2023
• Study Completion (Actual): February 21, 2024

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Monoclonal Antibody; Atopic Dermatitis; Atopic Eczema; KY1005; OX40L
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: KY1005-CT05/DRI17366; 2021-000725-28 (EudraCT Number); U1111-1271-1438 (Other Identifier: Universal Trial Number); DRI17366 (Other Identifier: Sponsor)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.

Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No