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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05131477




Registration number
NCT05131477
Ethics application status
Date submitted
11/11/2021
Date registered
23/11/2021
Date last updated
30/04/2024

Titles & IDs
Public title
Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study
Scientific 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
Secondary ID [1] 0 0
2021-000725-28
Secondary ID [2] 0 0
KY1005-CT05/DRI17366
Universal Trial Number (UTN)
Trial acronym
STREAM-AD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eczema 0 0
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KY1005
Treatment: Drugs - Placebo

Experimental: KY1005 Dose Level 1 - Every 4 weeks

Experimental: KY1005 Dose Level 2 - Every 4 weeks

Experimental: KY1005 Dose Level 3 - Every 4 weeks

Experimental: KY1005 Dose Level 4 - Every 4 weeks

Placebo Comparator: Placebo - Every 4 weeks


Treatment: Drugs: KY1005
Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Treatment: Drugs: Placebo
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage change in EASI (Eczema Area and Severity Index) from Baseline
Timepoint [1] 0 0
Baseline to Day 113
Secondary outcome [1] 0 0
Incidence of treatment-emergent adverse event
Timepoint [1] 0 0
Baseline through Day 477
Secondary outcome [2] 0 0
Serum KY1005 concentration assessed throughout the study
Timepoint [2] 0 0
Baseline through Day 477
Secondary outcome [3] 0 0
Percentage change in EASI (Eczema Area and Severity Index) from baseline to Day 169
Timepoint [3] 0 0
Baseline to Day 169
Secondary outcome [4] 0 0
Percentage of patients with at least a 75% reduction from Baseline in EASI (EASI 75)
Timepoint [4] 0 0
At Days 113 and 169
Secondary outcome [5] 0 0
Percentage of patients with a response of IGA (Investigator Global Assessment) 0 or 1 and a reduction from baseline = 2 points
Timepoint [5] 0 0
At Days 113 and 169
Secondary outcome [6] 0 0
Proportion of patients with improvement (reduction) of weekly average of pruritus NRS (Numerical Rating Scale) = 4 with a baseline pruritus of = 4 from baseline
Timepoint [6] 0 0
Days 113 and 169
Secondary outcome [7] 0 0
Absolute change from Baseline in EASI (Eczema Area and Severity Index)
Timepoint [7] 0 0
At Days 15, 29, 57, 85, 113, 141 and 169
Secondary outcome [8] 0 0
Percentage change from Baseline in EASI (Eczema Area and Severity Index)
Timepoint [8] 0 0
At Days 15, 29, 57, 85 and 141
Secondary outcome [9] 0 0
Percentage of patients with at least a 50% reduction from Baseline in EASI (EASI 50)
Timepoint [9] 0 0
At Days 15, 29, 57, 85, 113, 141 and 169
Secondary outcome [10] 0 0
Percentage of patients with at least a 75% reduction from Baseline in EASI (EASI 75)
Timepoint [10] 0 0
At Days 15, 29, 57, 85, and 141
Secondary outcome [11] 0 0
Percentage of patients with at least a 90% reduction from Baseline in EASI (EASI 90)
Timepoint [11] 0 0
At Days 15, 29, 57, 85, 113, 141 and 169
Secondary outcome [12] 0 0
Percentage of patients with a 100% reduction from Baseline in EASI (EASI 100)
Timepoint [12] 0 0
At Days 15, 29, 57, 85, 113, 141 and 169
Secondary outcome [13] 0 0
Change in IGA (Investigator Global Assessment) from Baseline
Timepoint [13] 0 0
Baseline to day 113 and over time up to Day 365
Secondary outcome [14] 0 0
Percentage of patients with a score of IGA (Investigator Global Assessment) 0 or 1 and a reduction from Baseline of = 2 points
Timepoint [14] 0 0
At Days 15, 29, 57, 85, and 141
Secondary outcome [15] 0 0
Absolute and Percentage change in SCORAD (SCORing Atopic Dermatitis) Index from Baseline
Timepoint [15] 0 0
Baseline to Day 169 and over time up to Day 365
Secondary outcome [16] 0 0
Absolute and Percentage change in affected BSA from Baseline
Timepoint [16] 0 0
Baseline to Day 169 and over time up to Day 365
Secondary outcome [17] 0 0
Absolute and Percentage change in Patient Oriented Eczema Measure (POEM) from Baseline
Timepoint [17] 0 0
Baseline to Day 169 and over time up to Day 365
Secondary outcome [18] 0 0
Absolute and Percentage change in Dermatology Life Quality Index (DLQI) from Baseline
Timepoint [18] 0 0
Baseline to Day 169 and over time up to Day 365
Secondary outcome [19] 0 0
Absolute and Percentage change in Atopic Dermatitis Control Tool (ADCT) from Baseline
Timepoint [19] 0 0
Baseline to Day 169 and over time up to Day 365
Secondary outcome [20] 0 0
Absolute and Percentage change in Hospital Anxiety and Depression Scale (HADS) from Baseline
Timepoint [20] 0 0
Baseline to Day 169 and over time up to Day 365
Secondary outcome [21] 0 0
Absolute and Percentage change in weekly average of pruritus Numerical Rating Scale (NRS) from Baseline
Timepoint [21] 0 0
Baseline to Day 169 and over time up to Day 365
Secondary outcome [22] 0 0
Proportion of patients with improvement (reduction) of weekly average of pruritus NRS (Numerical Rating Scale) = 3 with a baseline pruritus NRS = 3 from baseline
Timepoint [22] 0 0
Baseline to Days 113 and 169
Secondary outcome [23] 0 0
Incidence of positive anti-Ky1005 antibody response
Timepoint [23] 0 0
Baseline through Day 477
Secondary outcome [24] 0 0
Time to loss of EASI 75
Timepoint [24] 0 0
Week 24 to Day 365
Secondary outcome [25] 0 0
Time to loss of IGA 0/1 (Patients with a response of 0 or 1 in IGA)
Timepoint [25] 0 0
Week 24 to Day 365
Secondary outcome [26] 0 0
Time to loss of EASI 50
Timepoint [26] 0 0
Week 24 to Day 365

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/02/2024
Sample size
Target
Accrual to date
Final
390
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigative Site Number 3002 - Carlton
Recruitment hospital [2] 0 0
Investigative Site Number: 3003 - East Melbourne
Recruitment hospital [3] 0 0
Investigational Site Number: 3001 - Parkville
Recruitment postcode(s) [1] 0 0
3053 - Carlton
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Pleven
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Sofia
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Stara Zagora
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Czechia
State/province [18] 0 0
Jihomoravský Kraj
Country [19] 0 0
Czechia
State/province [19] 0 0
Moravskoslezský Kraj
Country [20] 0 0
Czechia
State/province [20] 0 0
Praha, Hlavní Mesto
Country [21] 0 0
Czechia
State/province [21] 0 0
Kutná Hora
Country [22] 0 0
Czechia
State/province [22] 0 0
Ostrava
Country [23] 0 0
Germany
State/province [23] 0 0
Bayern
Country [24] 0 0
Germany
State/province [24] 0 0
Brandenburg
Country [25] 0 0
Germany
State/province [25] 0 0
Nordrhein-Westfalen
Country [26] 0 0
Germany
State/province [26] 0 0
Schleswig-Holstein
Country [27] 0 0
Germany
State/province [27] 0 0
Berlin
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Hungary
State/province [29] 0 0
Bács-Kiskun
Country [30] 0 0
Hungary
State/province [30] 0 0
Békés
Country [31] 0 0
Hungary
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Csongrád
Country [32] 0 0
Hungary
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Hajdú-Bihar
Country [33] 0 0
Hungary
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Jász-Nagykun-Szolnok
Country [34] 0 0
Hungary
State/province [34] 0 0
Zala
Country [35] 0 0
Hungary
State/province [35] 0 0
Budapest
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Japan
State/province [36] 0 0
Hokkaidô
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Japan
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Kagosima
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Japan
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Kanagawa
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Japan
State/province [39] 0 0
Tiba
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Japan
State/province [40] 0 0
Tokyo
Country [41] 0 0
Japan
State/province [41] 0 0
Kyoto-Shi
Country [42] 0 0
Japan
State/province [42] 0 0
Mibu-machi
Country [43] 0 0
Japan
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Sapporo
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Japan
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Ôsaka
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Poland
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Dolnoslaskie
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Poland
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Lodzkie
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Poland
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Lódzkie
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Poland
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Malopolskie
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Poland
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Mazowieckie
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Podkarpackie
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Podlaskie
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Poland
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Pomorskie
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Poland
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Slaskie
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Poland
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Zachodniopomorskie
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Poland
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Bialystok
Country [56] 0 0
Poland
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Gdansk
Country [57] 0 0
Poland
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Krakow
Country [58] 0 0
Poland
State/province [58] 0 0
Lódz
Country [59] 0 0
Spain
State/province [59] 0 0
Valencia
Country [60] 0 0
Spain
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Alicante
Country [61] 0 0
Spain
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Córdoba
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Spain
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Madrid
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Spain
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Pontevedra
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Taiwan
State/province [64] 0 0
Niao Song Qu
Country [65] 0 0
Taiwan
State/province [65] 0 0
Taichung
Country [66] 0 0
Taiwan
State/province [66] 0 0
Taipei
Country [67] 0 0
Taiwan
State/province [67] 0 0
Taoyuan
Country [68] 0 0
United Kingdom
State/province [68] 0 0
London
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Kymab Limited
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05131477
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05131477