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

Primary Purpose

Eczema, Atopic Dermatitis

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

KY1005

Placebo

About this trial

This is an interventional treatment trial for Eczema focused on measuring KY1005, Monoclonal Antibody, Atopic Dermatitis, Atopic Eczema, OX40L

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

KY1005 Dose Level 1

KY1005 Dose Level 2

KY1005 Dose Level 3

KY1005 Dose Level 4

Placebo

Arm Description

Every 4 weeks

Outcomes

Primary Outcome Measures

Percentage change in EASI (Eczema Area and Severity Index) from Baseline

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

Serum KY1005 concentration assessed throughout the study

Percentage change in EASI (Eczema Area and Severity Index) from 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)

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

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

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)

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)

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)

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)

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)

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)

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

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

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

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

Absolute and Percentage change in Patient Oriented Eczema Measure (POEM) from Baseline

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

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

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

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

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

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 to loss of EASI 75

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)

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

The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition.

Full Information

NCT ID

NCT05131477

First Posted

November 11, 2021

Last Updated

August 7, 2023

Sponsor

Kymab Limited

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT05131477

Brief Title

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

Acronym

STREAM-AD

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 14, 2021 (Actual)

Primary Completion Date

March 15, 2023 (Actual)

Study Completion Date

February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kymab Limited

Collaborators

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eczema, Atopic Dermatitis

Keywords

KY1005, Monoclonal Antibody, Atopic Dermatitis, Atopic Eczema, OX40L

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

390 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KY1005 Dose Level 1

Arm Type

Experimental

Arm Description

Every 4 weeks

Arm Title

KY1005 Dose Level 2

Arm Type

Experimental

Arm Description

Every 4 weeks

Arm Title

KY1005 Dose Level 3

Arm Type

Experimental

Arm Description

Every 4 weeks

Arm Title

KY1005 Dose Level 4

Arm Type

Experimental

Arm Description

Every 4 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Every 4 weeks

Intervention Type

Drug

Intervention Name(s)

KY1005

Other Intervention Name(s)

Amlitelimab, SAR445229, A human anti-OX40 ligand monoclonal antibody

Intervention Description

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Primary Outcome Measure Information:

Title

Percentage change in EASI (Eczema Area and Severity Index) from Baseline

Description

The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.

Time Frame

Baseline to Day 113

Secondary Outcome Measure Information:

Title

Incidence of treatment-emergent adverse event

Time Frame

Baseline through Day 477

Title

Serum KY1005 concentration assessed throughout the study

Time Frame

Baseline through Day 477

Title

Percentage change in EASI (Eczema Area and Severity Index) from baseline to Day 169

Description

The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.

Time Frame

Baseline to Day 169

Title

Percentage of patients with at least a 75% reduction from Baseline in EASI (EASI 75)

Description

The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.

Time Frame

At Days 113 and 169

Title

Percentage of patients with a response of IGA (Investigator Global Assessment) 0 or 1 and a reduction from baseline ≥ 2 points

Description

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 Frame

At Days 113 and 169

Title

Proportion of patients with improvement (reduction) of weekly average of pruritus NRS (Numerical Rating Scale) ≥ 4 with a baseline pruritus of ≥ 4 from baseline

Description

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'.

Time Frame

Days 113 and 169

Title

Absolute change from Baseline in EASI (Eczema Area and Severity Index)

Description

The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.

Time Frame

At Days 15, 29, 57, 85, 113, 141 and 169

Title

Percentage change from Baseline in EASI (Eczema Area and Severity Index)

Description

The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.

Time Frame

At Days 15, 29, 57, 85 and 141

Title

Percentage of patients with at least a 50% reduction from Baseline in EASI (EASI 50)

Description

The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.

Time Frame

At Days 15, 29, 57, 85, 113, 141 and 169

Title

Percentage of patients with at least a 75% reduction from Baseline in EASI (EASI 75)

Description

The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.

Time Frame

At Days 15, 29, 57, 85, and 141

Title

Percentage of patients with at least a 90% reduction from Baseline in EASI (EASI 90)

Description

The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.

Time Frame

At Days 15, 29, 57, 85, 113, 141 and 169

Title

Percentage of patients with a 100% reduction from Baseline in EASI (EASI 100)

Description

The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition.

Time Frame

At Days 15, 29, 57, 85, 113, 141 and 169

Title

Change in IGA (Investigator Global Assessment) from Baseline

Description

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 Frame

Baseline to day 113 and over time up to Day 365

Title

Percentage of patients with a score of IGA (Investigator Global Assessment) 0 or 1 and a reduction from Baseline of ≥ 2 points

Description

Time Frame

At Days 15, 29, 57, 85, and 141

Title

Absolute and Percentage change in SCORAD (SCORing Atopic Dermatitis) Index from Baseline

Description

Time Frame

Baseline to Day 169 and over time up to Day 365

Title

Absolute and Percentage change in affected BSA from Baseline

Time Frame

Baseline to Day 169 and over time up to Day 365

Title

Absolute and Percentage change in Patient Oriented Eczema Measure (POEM) from Baseline

Description

Time Frame

Baseline to Day 169 and over time up to Day 365

Title

Absolute and Percentage change in Dermatology Life Quality Index (DLQI) from Baseline

Description

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

Time Frame

Baseline to Day 169 and over time up to Day 365

Title

Absolute and Percentage change in Atopic Dermatitis Control Tool (ADCT) from Baseline

Description

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

Time Frame

Baseline to Day 169 and over time up to Day 365

Title

Absolute and Percentage change in Hospital Anxiety and Depression Scale (HADS) from Baseline

Description

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

Time Frame

Baseline to Day 169 and over time up to Day 365

Title

Absolute and Percentage change in weekly average of pruritus Numerical Rating Scale (NRS) from Baseline

Description

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'.

Time Frame

Baseline to Day 169 and over time up to Day 365

Title

Proportion of patients with improvement (reduction) of weekly average of pruritus NRS (Numerical Rating Scale) ≥ 3 with a baseline pruritus NRS ≥ 3 from baseline

Description

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'.

Time Frame

Baseline to Days 113 and 169

Title

Incidence of positive anti-Ky1005 antibody response

Time Frame

Baseline through Day 477

Title

Time to loss of EASI 75

Description

The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition.

Time Frame

Week 24 to Day 365

Title

Time to loss of IGA 0/1 (Patients with a response of 0 or 1 in IGA)

Description

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 Frame

Week 24 to Day 365

Title

Time to loss of EASI 50

Description

The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition.

Time Frame

Week 24 to Day 365

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Investigative Site Number: 1018

City

Fremont

State/Province

California

ZIP/Postal Code

94538-1601

Country

United States

Facility Name

Investigative site #1022

City

Sacramento

State/Province

California

ZIP/Postal Code

95816-3370

Country

United States

Facility Name

Investigative Site Number: 1006

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33428

Country

United States

Facility Name

Investigative Site Number: 1001

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756-3424

Country

United States

Facility Name

Investigative Site Number: 1019

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134-2950

Country

United States

Facility Name

Investigative Site Number: 1007

City

Miami

State/Province

Florida

ZIP/Postal Code

33176-2264

Country

United States

Facility Name

Investigative Site Number: 1013

City

Tampa

State/Province

Florida

ZIP/Postal Code

33615-3816

Country

United States

Facility Name

Investigative Site Number: 1004

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406-2668

Country

United States

Facility Name

Investigative Site Number: 1010

City

Clarksville

State/Province

Indiana

ZIP/Postal Code

47129-2201

Country

United States

Facility Name

Investigative Site Number: 1015

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46250-2041

Country

United States

Facility Name

Investigative Site Number: 1021

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40241

Country

United States

Facility Name

Investigative Site Number: 1011

City

Towson

State/Province

Maryland

ZIP/Postal Code

21204-7448

Country

United States

Facility Name

Investigative Site Number: 1014

City

Beverly

State/Province

Massachusetts

ZIP/Postal Code

01915-1666

Country

United States

Facility Name

Investigative Site Number: 1012

City

Troy

State/Province

Michigan

ZIP/Postal Code

48084-3536

Country

United States

Facility Name

Investigative Site Number: 1005

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136-7049

Country

United States

Facility Name

Investigative Site Number: 1017

City

Portland

State/Province

Oregon

ZIP/Postal Code

97223-6683

Country

United States

Facility Name

Investigative Site Number: 1009

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Investigative Site Number: 1003

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621-2062

Country

United States

Facility Name

Investigative Site Number: 1008

City

Murfreesboro

State/Province

Tennessee

ZIP/Postal Code

37130-2450

Country

United States

Facility Name

Investigative site #1023

City

Mansfield

State/Province

Texas

ZIP/Postal Code

76063

Country

United States

Facility Name

Investigative Site Number 3002

City

Carlton

ZIP/Postal Code

3053

Country

Australia

Facility Name

Investigative Site Number: 3003

City

East Melbourne

ZIP/Postal Code

3002

Country

Australia

Facility Name

Investigational Site Number: 3001

City

Parkville

ZIP/Postal Code

3050

Country

Australia

Facility Name

Investigative Site Number: 2004

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Investigative Site Number: 2005

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Investigative Site Number: 2006

City

Sofia

ZIP/Postal Code

1592

Country

Bulgaria

Facility Name

Investigative Site Number: 2003

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

Facility Name

Investigative Site Number: 2002

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

Investigative Site Number: 2001

City

Stara Zagora

ZIP/Postal Code

6003

Country

Bulgaria

Facility Name

Investigative Site Number: 1106

City

Markham

State/Province

Ontario

ZIP/Postal Code

L3P 1X2

Country

Canada

Facility Name

Investigative site #1108

City

Niagara Falls

State/Province

Ontario

ZIP/Postal Code

L2H 1H5

Country

Canada

Facility Name

Investigative Site Number: 1103

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K2C 3N2

Country

Canada

Facility Name

Investigative Site Number: 1107

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Investigative Site Number: 1101

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8W 1E6

Country

Canada

Facility Name

Investigative Site Number: 2108

City

Brno

State/Province

Jihomoravský Kraj

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Investigative Site Number: 2105

City

Nový Jicín

State/Province

Moravskoslezský Kraj

ZIP/Postal Code

741 01

Country

Czechia

Facility Name

Investigative Site Number: 2102

City

Praha

State/Province

Praha, Hlavní Mesto

ZIP/Postal Code

108 00

Country

Czechia

Facility Name

Investigative Site Number: 2103

City

Praha

State/Province

Praha, Hlavní Mesto

ZIP/Postal Code

130 00

Country

Czechia

Facility Name

Investigative Site Number: 2106

City

Kutná Hora

ZIP/Postal Code

284 01

Country

Czechia

Facility Name

Investigative Site Number: 2104

City

Ostrava

ZIP/Postal Code

702 00

Country

Czechia

Facility Name

Investigative Site Number: 2209

City

Erlangen

State/Province

Bayern

ZIP/Postal Code

91054

Country

Germany

Facility Name

Investigative Site Number: 2202

City

Blankenfelde

State/Province

Brandenburg

ZIP/Postal Code

15827

Country

Germany

Facility Name

Investigator Site Number: 2201

City

Münster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48149

Country

Germany

Facility Name

Investigative Site Number: 2208

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

2405

Country

Germany

Facility Name

Investigative Site Number: 2203

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Investigative Site Number: 2204

City

Hamburg

ZIP/Postal Code

20251

Country

Germany

Facility Name

Investigative Site Number: 2307

City

Kecskemét

State/Province

Bács-Kiskun

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Investigative Site Number: 2305

City

Gyula

State/Province

Békés

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Investigative Site Number: 2301

City

Szeged

State/Province

Csongrád

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Investigative Site Number: 2303

City

Debrecen

State/Province

Hajdú-Bihar

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Investigative Site Number: 2306

City

Szolnok

State/Province

Jász-Nagykun-Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Investigative Site Number: 2302

City

Zalaegerszeg

State/Province

Zala

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Investigative Site Number: 2304

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Investigative Site Number: 3114

City

Obihiro-Shi

State/Province

Hokkaidô

ZIP/Postal Code

080-0013

Country

Japan

Facility Name

Investigative site #3108

City

Kagoshima-Shi

State/Province

Kagosima

ZIP/Postal Code

890-0063

Country

Japan

Facility Name

Investigative site #3113

City

Yokohama-Shi

State/Province

Kanagawa

ZIP/Postal Code

221-0825

Country

Japan

Facility Name

Investigative Site Number: 3103

City

Matsudo

State/Province

Tiba

ZIP/Postal Code

270-2223

Country

Japan

Facility Name

Investigative Site Number: 3112

City

Adachi-Ku

State/Province

Tokyo

ZIP/Postal Code

120-0034

Country

Japan

Facility Name

Investigative Site Number: 3115

City

Chuo Ku

State/Province

Tokyo

Country

Japan

Facility Name

Investigative Site Number: 3104

City

Edagowa-Ku

State/Province

Tokyo

ZIP/Postal Code

133-0052

Country

Japan

Facility Name

Investigative Site Number: 3111

City

Koto-Ku

State/Province

Tokyo

ZIP/Postal Code

136-0074

Country

Japan

Facility Name

Investigative Site Number: 3107

City

Minato-Ku

State/Province

Tokyo

ZIP/Postal Code

108-0014

Country

Japan

Facility Name

Investigative site #3105

City

Setagaya-Ku

State/Province

Tokyo

ZIP/Postal Code

158-0097

Country

Japan

Facility Name

Investigative site #3102

City

Kyoto-Shi

ZIP/Postal Code

602-0841

Country

Japan

Facility Name

Investigative Site Number: 3106

City

Mibu-machi

ZIP/Postal Code

321-0293

Country

Japan

Facility Name

Investigative site #3101

City

Sapporo

ZIP/Postal Code

060-0063

Country

Japan

Facility Name

Investigative Site Number: 3109

City

Habikino-Shi

State/Province

Ôsaka

ZIP/Postal Code

583-0872

Country

Japan

Facility Name

Investigative Site Number: 3110

City

Sakai-Shi

State/Province

Ôsaka

ZIP/Postal Code

593-8324

Country

Japan

Facility Name

Investigative Site Number: 2414

City

Wrocław

State/Province

Dolnoslaskie

ZIP/Postal Code

50-088

Country

Poland

Facility Name

Investigative Site Number: 2418

City

Wrocław

State/Province

Dolnoslaskie

ZIP/Postal Code

50-368

Country

Poland

Facility Name

Investigative Site Number: 2417

City

Wrocław

State/Province

Dolnoslaskie

ZIP/Postal Code

51-685

Country

Poland

Facility Name

Investigative Site Number: 2416

City

Łódź

State/Province

Lodzkie

ZIP/Postal Code

90-436

Country

Poland

Facility Name

Investigative Site Number: 2415

City

Lódz

State/Province

Lódzkie

ZIP/Postal Code

90-127

Country

Poland

Facility Name

Investigative Site Number: 2420

City

Łódź

State/Province

Lódzkie

ZIP/Postal Code

90-349

Country

Poland

Facility Name

Investigative Site Number: 2408

City

Kraków

State/Province

Malopolskie

ZIP/Postal Code

30-033

Country

Poland

Facility Name

Investigative Site Number: 2407

City

Kraków

State/Province

Malopolskie

ZIP/Postal Code

30-510

Country

Poland

Facility Name

Investigative Site Number: 2409

City

Kraków

State/Province

Malopolskie

ZIP/Postal Code

31-011

Country

Poland

Facility Name

Investigative Site Number: 2412

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

00-874

Country

Poland

Facility Name

Investigative Site Number: 2411

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

01-142

Country

Poland

Facility Name

Investigative Site Number: 2413

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

01-192

Country

Poland

Facility Name

Investigative Site Number: 2401

City

Rzeszów

State/Province

Podkarpackie

ZIP/Postal Code

35-055

Country

Poland

Facility Name

Investigative site #2419

City

Bialystok

State/Province

Podlaskie

ZIP/Postal Code

15-879

Country

Poland

Facility Name

Investigative Site Number: 2402

City

Gdańsk

State/Province

Pomorskie

ZIP/Postal Code

80-382

Country

Poland

Facility Name

Investigative Site Number: 2404

City

Gdynia

State/Province

Pomorskie

ZIP/Postal Code

81-384

Country

Poland

Facility Name

Investigative Site Number: 2405

City

Katowice

State/Province

Slaskie

ZIP/Postal Code

40-040

Country

Poland

Facility Name

Investigative Site Number: 2410

City

Szczecin

State/Province

Zachodniopomorskie

ZIP/Postal Code

71-434

Country

Poland

Facility Name

Investigative site #2419

City

Białystok

ZIP/Postal Code

15-879

Country

Poland

Facility Name

Investigative Site Number: 2403

City

Gdańsk

ZIP/Postal Code

80-592

Country

Poland

Facility Name

Investigative Site Number: 2406

City

Krakow

ZIP/Postal Code

31-559

Country

Poland

Facility Name

Investigative site #2420

City

Łódź

ZIP/Postal Code

90-349

Country

Poland

Facility Name

Investigative Site Number: 2502

City

Manises

State/Province

Valencia

ZIP/Postal Code

46940

Country

Spain

Facility Name

Investigative Site Number: 2505

City

Alicante

ZIP/Postal Code

3010

Country

Spain

Facility Name

Investigative Site Number: 2501

City

Córdoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Investigative Site Number: 2503

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Investigative Site Number: 2504

City

Pontevedra

ZIP/Postal Code

36001

Country

Spain

Facility Name

Investigative Site Number: 3201

City

Niao Song Qu

ZIP/Postal Code

833

Country

Taiwan

Facility Name

Investigative Site Number: 3202

City

Taichung

ZIP/Postal Code

402

Country

Taiwan

Facility Name

Investigative site # 3206

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Investigative site # 3206

City

Taipei

ZIP/Postal Code

112217

Country

Taiwan

Facility Name

Investigative Site Number: 3203

City

Taoyuan

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Investigative Site Number: 2603

City

London

ZIP/Postal Code

E11 1NR

Country

United Kingdom

Facility Name

Investigative Site Number: 2601

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Investigative Site Number: 2602

City

Sheffield

ZIP/Postal Code

S10 2TF

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://vivli.org

Learn more about this trial

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

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

Eczema, Atopic Dermatitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial