Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study (STREAM-AD)
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| ClinicalTrials.gov Identifier: NCT05131477 |
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Recruitment Status :
Active, not recruiting
First Posted : November 23, 2021
Last Update Posted : August 8, 2023
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Sponsor:
Kymab Limited
Collaborator:
Sanofi
Information provided by (Responsible Party):
Kymab Limited
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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 protocol at either Day 169 depending on responder status or no later than Day 365 due to loss of clinical response.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Eczema Atopic Dermatitis | Drug: KY1005 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 390 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | December 14, 2021 |
| Actual Primary Completion Date : | March 15, 2023 |
| Estimated Study Completion Date : | February 28, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Atopic dermatitis
MedlinePlus related topics:
Eczema
| Arm | Intervention/treatment |
|---|---|
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Experimental: KY1005 Dose Level 1
Every 4 weeks
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Drug: KY1005
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Other Names:
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Experimental: KY1005 Dose Level 2
Every 4 weeks
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Drug: KY1005
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Other Names:
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Experimental: KY1005 Dose Level 3
Every 4 weeks
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Drug: KY1005
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Other Names:
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Experimental: KY1005 Dose Level 4
Every 4 weeks
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Drug: KY1005
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Other Names:
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Placebo Comparator: Placebo
Every 4 weeks
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Drug: Placebo
Pharmaceutical form: Injection solution Route of administration: Subcutaneous |
Primary Outcome Measures :
- Percentage change in EASI (Eczema Area and Severity Index) from Baseline [ Time Frame: Baseline to Day 113 ]The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.
Secondary Outcome Measures :
- Incidence of treatment-emergent adverse event [ Time Frame: Baseline through Day 477 ]
- Serum KY1005 concentration assessed throughout the study [ Time Frame: Baseline through Day 477 ]
- Percentage change in EASI (Eczema Area and Severity Index) from baseline to Day 169 [ Time Frame: Baseline to Day 169 ]The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.
- Percentage of patients with at least a 75% reduction from Baseline in EASI (EASI 75) [ Time Frame: At Days 113 and 169 ]The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.
- Percentage of patients with a response of IGA (Investigator Global Assessment) 0 or 1 and a reduction from baseline ≥ 2 points [ Time Frame: At Days 113 and 169 ]The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe AD.
- Proportion of patients with improvement (reduction) of weekly average of pruritus NRS (Numerical Rating Scale) ≥ 4 with a baseline pruritus of ≥ 4 from baseline [ Time Frame: Days 113 and 169 ]The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
- Absolute change from Baseline in EASI (Eczema Area and Severity Index) [ Time Frame: At Days 15, 29, 57, 85, 113, 141 and 169 ]The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.
- Percentage change from Baseline in EASI (Eczema Area and Severity Index) [ Time Frame: At Days 15, 29, 57, 85 and 141 ]The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.
- Percentage of patients with at least a 50% reduction from Baseline in EASI (EASI 50) [ Time Frame: At Days 15, 29, 57, 85, 113, 141 and 169 ]The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.
- Percentage of patients with at least a 75% reduction from Baseline in EASI (EASI 75) [ Time Frame: At Days 15, 29, 57, 85, and 141 ]The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.
- Percentage of patients with at least a 90% reduction from Baseline in EASI (EASI 90) [ Time Frame: At Days 15, 29, 57, 85, 113, 141 and 169 ]The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.
- Percentage of patients with a 100% reduction from Baseline in EASI (EASI 100) [ Time Frame: At Days 15, 29, 57, 85, 113, 141 and 169 ]The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.
- Change in IGA (Investigator Global Assessment) from Baseline [ Time Frame: Baseline to day 113 and over time up to Day 365 ]The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
- Percentage of patients with a score of IGA (Investigator Global Assessment) 0 or 1 and a reduction from Baseline of ≥ 2 points [ Time Frame: At Days 15, 29, 57, 85, and 141 ]The IGA is a five-point scale that provides a global clinical assessment of AD (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 [ Time Frame: Baseline to Day 169 and over time up to Day 365 ]SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
- Absolute and Percentage change in affected BSA from Baseline [ Time Frame: Baseline to Day 169 and over time up to Day 365 ]
- Absolute and Percentage change in Patient Oriented Eczema Measure (POEM) from Baseline [ Time Frame: Baseline to Day 169 and over time up to Day 365 ]POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
- Absolute and Percentage change in Dermatology Life Quality Index (DLQI) from Baseline [ Time Frame: Baseline to Day 169 and over time up to Day 365 ]DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
- Absolute and Percentage change in Atopic Dermatitis Control Tool (ADCT) from Baseline [ Time Frame: Baseline to Day 169 and over time up to Day 365 ]ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
- Absolute and Percentage change in Hospital Anxiety and Depression Scale (HADS) from Baseline [ Time Frame: Baseline to Day 169 and over time up to Day 365 ]HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression
- Absolute and Percentage change in weekly average of pruritus Numerical Rating Scale (NRS) from Baseline [ Time Frame: Baseline to Day 169 and over time up to Day 365 ]The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
- Proportion of patients with improvement (reduction) of weekly average of pruritus NRS (Numerical Rating Scale) ≥ 3 with a baseline pruritus NRS ≥ 3 from baseline [ Time Frame: Baseline to Days 113 and 169 ]The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
- Incidence of positive anti-Ky1005 antibody response [ Time Frame: Baseline through Day 477 ]
- Time to loss of EASI 75 [ Time Frame: Week 24 to Day 365 ]The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition.
- Time to loss of IGA 0/1 (Patients with a response of 0 or 1 in IGA) [ Time Frame: Week 24 to Day 365 ]The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe AD.
- Time to loss of EASI 50 [ Time Frame: Week 24 to Day 365 ]The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition.
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
- 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.
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05131477
Locations
Show 103 study locations
Sponsors and Collaborators
Kymab Limited
Sanofi
| Responsible Party: | Kymab Limited |
| ClinicalTrials.gov Identifier: | NCT05131477 |
| Other Study ID Numbers: |
KY1005-CT05/DRI17366 2021-000725-28 ( EudraCT Number ) U1111-1271-1438 ( Other Identifier: Universal Trial Number ) DRI17366 ( Other Identifier: Sponsor ) |
| First Posted: | November 23, 2021 Key Record Dates |
| Last Update Posted: | August 8, 2023 |
| Last Verified: | August 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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 |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| URL: | https://vivli.org |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Kymab Limited:
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KY1005 Monoclonal Antibody Atopic Dermatitis Atopic Eczema OX40L |
Additional relevant MeSH terms:
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Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |