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Completed

NCT Number: NCT05131477

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

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.

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Key information

Conditions

Eczema Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigative Site Number 3002, Carlton, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amlitelimab

Drug

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Other names: KY1005, SAR445229, A human anti-OX40 ligand monoclonal antibody

Placebo

Drug

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Primary outcomes

  1. Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1)

    Time frame: Baseline to week 16

    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.

Secondary outcomes

  1. Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1)

    Time frame: Baseline to week 24

    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.

  2. Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1)

    Time frame: Baseline to week 16 and week 24

    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.

  3. Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1)

    Time frame: Baseline to week 16 and week 24

    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.

  4. 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)

    Time frame: Baseline to week 16 and week 24

    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'.

  5. 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)

    Time frame: 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

    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'.

  6. Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)

    Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24

    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.

  7. Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)

    Time frame: Baseline to weeks 2,4, 8,12,16, 20 and 24

    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.

  8. Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)

    Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52

    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.

  9. Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)

    Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52

    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.

  10. Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)

    Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24

    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.

  11. Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)

    Time frame: Baseline at weeks 2, 4, 8, 12, 16, 20 and 24

    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.

  12. Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)

    Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24

    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.

  13. Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)

    Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24

    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.

  14. Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1)

    Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20, & 24

    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

  15. Change in IGA (Investigator Global Assessment) From Baseline (Part 2)

    Time frame: Baseline to weeks 24, 28, 31, 36, 40, 44, 48 & 52

    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

  16. Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1)

    Time frame: Baseline to weeks 2, 4, 8,12,16,20 & 24

    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

  17. Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)

    Time frame: Baseline to weeks 4, 8, 12, 16, 20 & 24

    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)

  18. Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)

    Time frame: Baseline to week 24, 28, 32, 36, 40, 44, 48 & 52

    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)

  19. Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)

    Time frame: Baseline to weeks 4, 8, 12, 16, 20, & 24

    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)

  20. Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)

    Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52

    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)

  21. Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)

    Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20, & 24

  22. Absolute Change in Affected BSA From Baseline (Part 2)

    Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52

  23. Percentage Change in Affected BSA From Baseline (Part 1)

    Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20, & 24

  24. Percentage Change in Affected BSA From Baseline (Part 2)

    Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52

  25. Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)

    Time frame: Baseline to weeks 4, 8, 12, 16, 20, & 24

    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

  26. Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)

    Time frame: Baseline to weeks 24, 32, 36, 40, 44, 48 & 52

    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

  27. Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)

    Time frame: Baseline to weeks 4, 8, 12, 16, 20, & 24

    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

  28. Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)

    Time frame: Baseline to weeks 24, 32, 36, 40. 44, 48, & 52

    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

  29. Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1)

    Time frame: Baseline to weeks 2, 8, 16, 20, & 24

    DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.

  30. Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)

    Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52

    DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.

  31. Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)

    Time frame: Baseline to weeks 2, 8, 16, 20, & 24

    DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.

  32. Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)

    Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52

    DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.

  33. Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)

    Time frame: Baseline to weeks 16, & 24

    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

  34. Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)

    Time frame: Baseline to weeks 24, 36 & 52

    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

  35. Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)

    Time frame: Baseline to weeks 16, & 24

    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

  36. Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)

    Time frame: Baseline to weeks 24, 36 & 52

    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

  37. Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)

    Time frame: Baseline to weeks 8 16, 20, & 24

    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.

  38. Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)

    Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52

    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.

  39. Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)

    Time frame: Baseline to weeks 8, 16, 20, & 24

    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.

  40. Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)

    Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52

    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.

  41. Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)

    Time frame: 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

    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'.

  42. Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)

    Time frame: 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

    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'.

  43. Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)

    Time frame: 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

    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'.

  44. Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)

    Time frame: 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

    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'.

  45. 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)

    Time frame: 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

    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'.

  46. Incidence Rate of Loss of EASI 50 (Part 2)

    Time frame: Week 24 to week 52

    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.

  47. Incidence Rate of Loss of EASI 75 (Part 2)

    Time frame: Week 24 to week 52

    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.

  48. Incidence Rate of Loss of IGA 0/1 (Part 2)

    Time frame: Week 24 to week 68

    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.

  49. Serum KY1005 Concentration Assessed Throughout the Study (Part 1)

    Time frame: Baseline and at weeks 1, 2, 4, 8, 12, 16, 17, 20, & 24

  50. Serum KY1005 Concentration Assessed Throughout the Study (Part 2)

    Time frame: Baseline and at weeks 24, 25, 28, 32, 36, 40, 44, 48, & 52

  51. Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1)

    Time frame: Baseline through week 24

  52. Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2)

    Time frame: Week 24 through week 68

  53. Percentage of Participants With Treatment-emergent ADA (Part 1)

    Time frame: Baseline through week 24

  54. Percentage of Participants With Treatment-emergent ADA (Part 2)

    Time frame: Baseline through week 68

Sponsors and collaborators

Lead sponsor

Kymab Limited

Industry

Collaborators

  • Sanofi

Registry information

Official study title

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

Acronym: STREAM-AD

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Nov 23, 2021
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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