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

NCT05131477
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Phase
Phase 2
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Recruitment status
Completed
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Participants
390
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Lead sponsor
Kymab Limited
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Start date
2021-12-13
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Number of sites
103
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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 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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Acronym
STREAM-AD
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Short title
Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study
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Official 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
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Control arm
Placebo
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2024-02-21
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First posted
2021-11-23
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Registry last updated
2025-07-03
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Primary completion date
2023-04-26
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Start date
2021-12-13
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Actual participants
390
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Participants
390
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Participant count basis
Actual
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Protocol amendments
6
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Number of sites
103
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Kymab Limited
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05131477
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ClinicalTrials.gov ID
NCT05131477
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: 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.

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

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

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

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

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

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

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

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

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

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

    Timeframe: 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

And 29 more, listed on the interactive page.

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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.

  • 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.

Sources for eligibility
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  • Investigative Site Number: 1018Fremont, United States
  • Investigative site #1022Sacramento, United States
  • Investigative Site Number: 1006Boca Raton, United States
  • Investigative Site Number: 1001Clearwater, United States
  • Investigative Site Number: 1019Coral Gables, United States
  • Investigative Site Number: 1007Miami, United States
  • Investigative Site Number: 1013Tampa, United States
  • Investigative Site Number: 1004Savannah, United States
  • Investigative Site Number: 1010Clarksville, United States
  • Investigative Site Number: 1015Indianapolis, United States
  • Investigative Site Number: 1021Louisville, United States
  • Investigative Site Number: 1011Towson, United States
  • Investigative Site Number: 1014Beverly, United States
  • Investigative Site Number: 1012Troy, United States
  • Investigative Site Number: 1005Tulsa, United States
  • Investigative Site Number: 1017Portland, United States
  • Investigative Site Number: 1009Portland, United States
  • Investigative Site Number: 1003Anderson, United States
  • Investigative Site Number: 1008Murfreesboro, United States
  • Investigative site #1023Mansfield, United States
  • Investigative Site Number 3002Carlton, Australia
  • Investigative Site Number: 3003East Melbourne, Australia
  • Investigational Site Number: 3001Parkville, Australia
  • Investigative Site Number: 2004Pleven, Bulgaria
  • Investigative Site Number: 2005Sofia, Bulgaria

And 78 more, listed on the interactive page.

Sources for sites
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  • DRI17366
  • 2021-000725-28
  • U1111-1271-1438
Sources for references
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Related records

Drugs (1)

Collaborators (1)

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Conditions (1)

Targets (1)