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

NCT05131477 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: KY1005-CT05/DRI173662021-000725-28U1111-1271-1438DRI17366
• Study Type: interventional
• Target: 390
• Locations: 12 countries
• Sites: 103

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 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.

Conditions

Eczema; Atopic Dermatitis

Keywords

KY1005; Monoclonal Antibody; Atopic Dermatitis; Atopic Eczema; OX40L

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline to week 16

Secondary Outcomes (54)

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

  Baseline to week 24

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

  Baseline to week 16 and week 24

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

  Baseline to week 16 and week 24

• 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)

  Baseline to week 16 and week 24

• 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)

  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

Study Arms (5)

250mg (500mg Loading Dose) KY1005

EXPERIMENTAL

Every 4 weeks

Drug: Amlitelimab

250mg (No Loading Dose) KY1005

EXPERIMENTAL

Every 4 weeks

Drug: Amlitelimab

125mg KY1005

EXPERIMENTAL

Every 4 weeks

Drug: Amlitelimab

62.5mg KY1005

EXPERIMENTAL

Every 4 weeks

Drug: Amlitelimab

Placebo

PLACEBO COMPARATOR

Every 4 weeks

Drug: Placebo

Interventions

Amlitelimab DRUG

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Also known as: KY1005, SAR445229, A human anti-OX40 ligand monoclonal antibody

125mg KY1005; 250mg (500mg Loading Dose) KY1005; 250mg (No Loading Dose) KY1005; 62.5mg KY1005

Placebo DRUG

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kymab Limited: lead
• Sanofi: collaborator

Study Sites (103)

Investigative Site Number: 1018

Fremont, California, 94538-1601, United States

Location

Investigative site #1022

Sacramento, California, 95816-3370, United States

Location

Investigative Site Number: 1006

Boca Raton, Florida, 33428, United States

Location

Investigative Site Number: 1001

Clearwater, Florida, 33756-3424, United States

Location

Investigative Site Number: 1019

Coral Gables, Florida, 33134-2950, United States

Location

Investigative Site Number: 1007

Miami, Florida, 33176-2264, United States

Location

Investigative Site Number: 1013

Tampa, Florida, 33615-3816, United States

Location

Investigative Site Number: 1004

Savannah, Georgia, 31406-2668, United States

Location

Investigative Site Number: 1010

Clarksville, Indiana, 47129-2201, United States

Location

Investigative Site Number: 1015

Indianapolis, Indiana, 46250-2041, United States

Location

Investigative Site Number: 1021

Louisville, Kentucky, 40241, United States

Location

Investigative Site Number: 1011

Towson, Maryland, 21204-7448, United States

Location

Investigative Site Number: 1014

Beverly, Massachusetts, 01915-1666, United States

Location

Investigative Site Number: 1012

Troy, Michigan, 48084-3536, United States

Location

Investigative Site Number: 1005

Tulsa, Oklahoma, 74136-7049, United States

Location

Investigative Site Number: 1017

Portland, Oregon, 97223-6683, United States

Location

Investigative Site Number: 1009

Portland, Oregon, 97239, United States

Location

Investigative Site Number: 1003

Anderson, South Carolina, 29621-2062, United States

Location

Investigative Site Number: 1008

Murfreesboro, Tennessee, 37130-2450, United States

Location

Investigative site #1023

Mansfield, Texas, 76063, United States

Location

Investigative Site Number 3002

Carlton, 3053, Australia

Location

Investigative Site Number: 3003

East Melbourne, 3002, Australia

Location

Investigational Site Number: 3001

Parkville, 3050, Australia

Location

Investigative Site Number: 2004

Pleven, 5800, Bulgaria

Location

Investigative Site Number: 2005

Sofia, 1431, Bulgaria

Location

Investigative Site Number: 2006

Sofia, 1592, Bulgaria

Location

Investigative Site Number: 2003

Sofia, 1612, Bulgaria

Location

Investigative Site Number: 2002

Sofia, 1784, Bulgaria

Location

Investigative Site Number: 2001

Stara Zagora, 6003, Bulgaria

Location

Investigative Site Number: 1106

Markham, Ontario, L3P 1X2, Canada

Location

Investigative site #1108

Niagara Falls, Ontario, L2H 1H5, Canada

Location

Investigative Site Number: 1103

Ottawa, Ontario, K2C 3N2, Canada

Location

Investigative Site Number: 1107

Waterloo, Ontario, N2J 1C4, Canada

Location

Investigative Site Number: 1101

Windsor, Ontario, N8W 1E6, Canada

Location

Investigative Site Number: 2105

Nový Jicín, Moravskoslezský kraj, 741 01, Czechia

Location

Investigative Site Number: 2102

Prague, Praha, Hlavní Mesto, 108 00, Czechia

Location

Investigative Site Number: 2103

Prague, Praha, Hlavní Mesto, 130 00, Czechia

Location

Investigative Site Number: 2108

Brno, South Moravian, 602 00, Czechia

Location

Investigative Site Number: 2106

Kutná Hora, 284 01, Czechia

Location

Investigative Site Number: 2104

Ostrava, 702 00, Czechia

Location

Investigative Site Number: 2209

Erlangen, Bavaria, 91054, Germany

Location

Investigative Site Number: 2202

Blankenfelde, Brandenburg, 15827, Germany

Location

Investigator Site Number: 2201

Münster, North Rhine-Westphalia, 48149, Germany

Location

Investigative Site Number: 2208

Kiel, Schleswig-Holstein, 2405, Germany

Location

Investigative Site Number: 2203

Berlin, 10117, Germany

Location

Investigative Site Number: 2204

Hamburg, 20251, Germany

Location

Investigative Site Number: 2305

Gyula, Bekes County, 5700, Hungary

Location

Investigative Site Number: 2307

Kecskemét, Bács-Kiskun county, 6000, Hungary

Location

Investigative Site Number: 2301

Szeged, Csongrád megye, 6720, Hungary

Location

Investigative Site Number: 2303

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Investigative Site Number: 2306

Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

Location

Investigative Site Number: 2302

Zalaegerszeg, Zala County, 8900, Hungary

Location

Investigative Site Number: 2304

Budapest, 1036, Hungary

Location

Investigative Site Number: 3103

Matsudo, Chiba, 270-2223, Japan

Location

Investigative Site Number: 3114

Obihiro-Shi, Hokkaidô, 080-0013, Japan

Location

Investigative site #3108

Kagoshima, Kagoshima-ken, 890-0063, Japan

Location

Investigative site #3113

Yokohama, Kanagawa, 221-0825, Japan

Location

Investigative Site Number: 3112

Adachi-Ku, Tokyo, 120-0034, Japan

Location

Investigative Site Number: 3115

Chuo Ku, Tokyo, Japan

Location

Investigative Site Number: 3104

Edagowa-Ku, Tokyo, 133-0052, Japan

Location

Investigative Site Number: 3111

Koto-Ku, Tokyo, 136-0074, Japan

Location

Investigative Site Number: 3107

Minato-Ku, Tokyo, 108-0014, Japan

Location

Investigative site #3105

Setagaya-Ku, Tokyo, 158-0097, Japan

Location

Investigative site #3102

Kyoto, 602-0841, Japan

Location

Investigative Site Number: 3106

Mibu-machi, 321-0293, Japan

Location

Investigative site #3101

Sapporo, 060-0063, Japan

Location

Investigative Site Number: 3109

Habikino-Shi, Ôsaka, 583-0872, Japan

Location

Investigative Site Number: 3110

Sakaishi, Ôsaka, 593-8324, Japan

Location

Investigative Site Number: 2408

Krakow, Lesser Poland Voivodeship, 30-033, Poland

Location

Investigative Site Number: 2407

Krakow, Lesser Poland Voivodeship, 30-510, Poland

Location

Investigative Site Number: 2409

Krakow, Lesser Poland Voivodeship, 31-011, Poland

Location

Investigative Site Number: 2414

Wroclaw, Lower Silesian Voivodeship, 50-088, Poland

Location

Investigative Site Number: 2418

Wroclaw, Lower Silesian Voivodeship, 50-368, Poland

Location

Investigative Site Number: 2417

Wroclaw, Lower Silesian Voivodeship, 51-685, Poland

Location

Investigative Site Number: 2420

Lodz, Lódzkie, 90-349, Poland

Location

Investigative Site Number: 2415

Lódz, Lódzkie, 90-127, Poland

Location

Investigative Site Number: 2412

Warsaw, Masovian Voivodeship, 00-874, Poland

Location

Investigative Site Number: 2411

Warsaw, Masovian Voivodeship, 01-142, Poland

Location

Investigative Site Number: 2413

Warsaw, Masovian Voivodeship, 01-192, Poland

Location

Investigative Site Number: 2401

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

Location

Investigative site #2419

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

Investigative Site Number: 2402

Gdansk, Pomeranian Voivodeship, 80-382, Poland

Location

Investigative Site Number: 2404

Gdynia, Pomeranian Voivodeship, 81-384, Poland

Location

Investigative Site Number: 2405

Katowice, Silesian Voivodeship, 40-040, Poland

Location

Investigative Site Number: 2410

Szczecin, West Pomeranian Voivodeship, 71-434, Poland

Location

Investigative site #2419

Bialystok, 15-879, Poland

Location

Investigative Site Number: 2403

Gdansk, 80-592, Poland

Location

Investigative Site Number: 2406

Krakow, 31-559, Poland

Location

Investigative site #2420

Lodz, 90-349, Poland

Location

Investigative Site Number: 2416

Lodz, Łódź Voivodeship, 90-436, Poland

Location

Investigative Site Number: 2502

Manises, Valencia, 46940, Spain

Location

Investigative Site Number: 2505

Alicante, 3010, Spain

Location

Investigative Site Number: 2501

Córdoba, 14004, Spain

Location

Investigative Site Number: 2503

Madrid, 28046, Spain

Location

Investigative Site Number: 2504

Pontevedra, 36001, Spain

Location

Investigative Site Number: 3201

Niao Song Qu, 833, Taiwan

Location

Investigative Site Number: 3202

Taichung, 402, Taiwan

Location

Investigative site # 3206

Taipei, 11217, Taiwan

Location

Investigative site # 3206

Taipei, 112217, Taiwan

Location

Investigative Site Number: 3203

Taoyuan District, 33305, Taiwan

Location

Investigative Site Number: 2603

London, E11 1NR, United Kingdom

Location

Investigative Site Number: 2601

London, SE1 9RT, United Kingdom

Location

Investigative Site Number: 2602

Sheffield, S10 2TF, United Kingdom

Location

Related Publications (3)

• Reich A, Blauvelt A, Weidinger S, Shi VY, Katoh N, Lynde C, Gao X, Armstrong NM, Bernigaud C, Rahawi K. A Post Hoc Analysis of Atopic Dermatitis of the Head and Neck and Other Body Regions from the Amlitelimab STREAM-AD Phase 2b Study. Dermatol Ther (Heidelb). 2025 Dec 8. doi: 10.1007/s13555-025-01609-6. Online ahead of print.

  PMID: 41359216 DERIVED

• Blauvelt A, Chovatiya R, Merola JF, Weidinger S, Igawa K, Brookes E, Weber C, Wang J, Gray C. Improvement and maintenance of clinical outcome assessments in atopic dermatitis with amlitelimab. J Eur Acad Dermatol Venereol. 2025 Dec;39(12):2113-2120. doi: 10.1111/jdv.20877. Epub 2025 Jul 24.

  PMID: 40704660 DERIVED

• Weidinger S, Blauvelt A, Papp KA, Reich A, Lee CH, Worm M, Lynde C, Kataoka Y, Foley P, Wei X, Wong W, Solente AC, Weber C, Adelman S, Davey S, Hurbin F, Rynkiewicz N, Yen K, O'Malley JT, Bernigaud C. Phase 2b randomized clinical trial of amlitelimab, an anti-OX40 ligand antibody, in patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol. 2025 Apr;155(4):1264-1275. doi: 10.1016/j.jaci.2024.10.031. Epub 2024 Nov 8.

  PMID: 39522654 DERIVED

Related Links

• DRI17366 Plain language Results Summary

MeSH Terms

Conditions

Eczema; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

contact-us@saonofi.com

800-633-1610

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 23, 2021
• Study Start: December 13, 2021
• Primary Completion: April 26, 2023
• Study Completion: February 21, 2024
• Last Updated: July 3, 2025
• Results First Posted: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

HU (7); BU (6); AU (3); ES (5); CZ (6); TW (5); JP (15); US (20); DE (6); PL (22); GB (3); CA (5)