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    EudraCT Number:2021-000725-28
    Sponsor's Protocol Code Number:KY1005-CT05/DRI17366
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-12-17
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2021-000725-28
    A.3Full title of the trial
    A Phase IIb, Randomised, Double Blind, Placebo Controlled, Parallel Group, Multicentre Dose Ranging Study of a Subcutaneous Anti-OX40L Monoclonal Antibody (KY1005) in Moderate to Severe Atopic Dermatitis
    Randomizované, dvojitě zaslepené, placebem kontrolované, multicentrické klinické hodnocení fáze IIb s paralelními skupinami zjišťující rozmezí dávky subkutánně podávané monoklonální protilátky proti OX40L (přípravek KY1005) u středně závažné až závažné atopické dermatitidy

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Subcutaneous Dose Ranging Study of KY1005 in Patients with Moderate to Severe Atopic Dermatitis
    Studie zkoumající rozmezí dávkování podkožně podávaného přípravku KY1005 u pacientů se středně závažnou až závažnou atopickou dermatitidou
    A.3.2Name or abbreviated title of the trial where available
    Study Testing Response Effect of KY1005 Against Moderate to Severe Atopic Dermatitis (STREAM-AD)
    A.4.1Sponsor's protocol code numberKY1005-CT05/DRI17366
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKymab Ltd, a Sanofi Company
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKymab Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKymab Limited
    B.5.2Functional name of contact pointDevelopment Clinical Trial Desk
    B.5.3 Address:
    B.5.3.1Street AddressThe Bennet Building (B930), Babraham Research Campus
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB22 3AT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441223833301
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameKY1005
    D.3.2Product code SAR445229
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN amlitelimab
    D.3.9.1CAS number 2378692-15-8
    D.3.9.2Current sponsor codeKY1005 and SAR445229
    D.3.9.3Other descriptive name KY1005 is a human anti-OX40 ligand (OX40L) monoclonal antibody
    D.3.9.4EV Substance CodeSUB187104
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D. medicinal product typeMonoclonal antibody
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atopic dermatitis
    E.1.1.1Medical condition in easily understood language
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the efficacy (including dose/exposure-response) across a range of KY1005 exposures, compared to Placebo, on the signs of Atopic Dermatitis (AD) using the Eczema Area and Severity Index (EASI) in those patients with a documented history, within 6 months prior to Baseline, of either inadequate response to topical treatments or inadvisability of topical treatments. Dose response of 4 different dose regimens of KY1005 in patients with AD versus Placebo will be evaluated.
    E.2.2Secondary objectives of the trial
    To characterize:
    *The efficacy (including dose/exposure-response) across a range of
    KY1005 exposures compared to Placebo on additional physician
    assessments of AD activity/severity: EASI at week24, EASI-75, IGA and NRS for pruritus.
    Also characterize:
    *Safety and tolerability of KY1005
    *The PK profile of KY1005 across a range of doses/exposures
    *The response across a range of KY1005 exposures on additional
    physician assessments of AD activity/severity EASI, EASI-50, EASI-75,
    EASI-90, EASI-100, IGA, SOCRAD and affected BSA.
    *The response across range of KY1005 exposures on patient-reported
    AD activity/severity; POEM, DLQI, ADCT, HADS & NRS for pruritus.
    *The PD response to KY1005 including but not limited to; the
    immunogenicity of KY1005, including the anti-KY1005 antibody
    *The maintenance of clinical response with in patients randomized to
    withdrawal of IMP who achieve ≥ EASI-75 or who attain IGA 0/1
    response following 24 weeks of treatment.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Within existing study protocol KY1005-CT05:
    Skin punch biopsies (5 mm) will be taken in up to approximately one third (30%) of patients who will be enrolled into a skin biopsy sub-study. This will be done at selected sites. Lesional and non-lesional samples will be collected at Baseline with lesional samples requested at Day 113.
    E.3Principal inclusion criteria
    • Adults (18 to < 75 years of age) with AD 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 BSA at Baseline.
    • Baseline worst/maximum pruritus NRS of ≥ 4. The baseline weekly average of daily worst/maximum pruritus NRS will be calculated from the 7 consecutive days immediately preceding the Baseline visit.
    • 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, including collection of NRS (pruritus) on each of the 7 days prior to Baseline. .
    • Able and willing to comply with requested study visits/telephone visits and procedures.
    • Able and willing to provide written informed consent. This document must also actually be presented at the time of inclusion.
    • For patients who decide to join the biopsy sub-study at sites selected for skin biopsy collection: be able and willing to provide skin biopsies at Baseline and Day113 (Week 16).
    E.4Principal exclusion criteria
    1. Treatment with any of the following prior to first IMP administration (Baseline):
    •Systemic corticosteroids, and systemic calcineurin inhibitors (tacrolimus and cyclosporin) within 4 weeks;
    •Leukotriene inhibitors within 4 weeks;
    •Systemic therapy for AD, including but not limited to methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4 (PDE4)-inhibitors, IFN-γ and mycophenolate mofetil within 4 weeks;
    •Targeted biologic and small molecule treatments within 5 half-lives or within 12 weeks prior to baseline, whichever is longer;
    •Previous treatment with systemic janus kinase (JAK)inhibitors at any point.
    •Topical corticosteroids, tacrolimus or pimecrolimus, or topical PDE4 within 7 days;
    •Prescription or non-prescription moisturisers with additives (e.g., urea, filaggrin) within 2 weeks;
    •Phototherapy or allergen immunotherapy within 4 weeks;
    •Regular use (> 2 visits/week) of a tanning booth/parlour within 4 weeks;
    •Any prior use of anti OX40 or anti OX40L mAb; including KY1005.
    •Investigational therapy for the treatment of AD or other conditions within 5 half-lives or the limit of PD effects or 12 weeks where the t1/2 is unknown.
    2. Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminth infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
    3. Weight < 40 kg or > 150 kg at Baseline.
    4. Treatment with a live (attenuated) immunisation within 12 weeks prior to Baseline; completion of required administrations of COVID-19 vaccine within 14 days prior to Baseline or within 14 days immediately prior to or following IMP administration.
    5. Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding .
    6.Any malignancies or history of malignancies prior to Baseline(except for non-melanoma skin cancer that has been excised and cured for more than 3years prior to Baseline;in situ cervical carcinoma that has been excised and cured).
    7. Positive for human immunodeficiency virus, hepatitis B surface antigen, hepatitis B core antibody or hepatitis C antibody at the Screening Visit.
    8. History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator.
    9. Current or any past history of tuberculosis or non-tuberculous mycobacterial infections (including a positive QuantiFERON®-Tuberculosis Gold blood test at the Screening Visit).
    10.Elective surgery planned to be scheduled for any time in the period from Screening up to 12 weeks following the last dose of IMP that in the investigator's opinion would impact the conduct of the trial.
    11.Anticipated initiation of prohibited medications from Screening up to 12 weeks following the last dose of IMP.
    12.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.
    13. Skin comorbidity that would adversely affect the ability to undertake AD assessments.
    14. Any medical or psychiatric condition which, in the opinion of the investigator may present an unreasonable risk to the study patient as a result of his/her participation in this clinical study, may make patient’s participation unreliable, or may interfere with study assessments.
    15. Any active or chronic infection requiring systemic treatment within 2 weeks prior to Baseline (1 week in the event of superficial skin infections).
    16. Laboratory values at the Screening Visit:
    •Serum creatinine>1.6 mg/dL(141μmol/L) in female patients and >1.9mg/dL(168 μmol/L) in male patients
    •ALT or AST>2.0x ULN •Serum total bilirubin >1.5 x ULN (except for subjects with Gilbert's syndrome, where total bilirubin must not exceed 3.0 mg/dL or 50μmol/L)
    •In the Investigator's opinion, any additional clinically significant laboratory results from the clinical chemistry, haematology or urinalysis tests at the Screening visit.
    17. In the Investigator’s opinion, any significant abnormality on 12-lead electrocardiogram (ECG) at the Screening Visit.
    18.History of or known or suspected hypersensitivity to KY1005 or the matching placebo formulation, or excipients used in the presentation of KY1005 or placebo, or in preparation for administration. History of or known or suspected severe hypersensitivity reactions to other mAbs and/or their excipients.
    19.Patients for whom coercion by either the Investigator or the Sponsor cannot be discounted. (No patients will be included who are related to, or in a relationship with, or employed by the Investigator, the Sponsor or any organisations contracted on behalf of the Sponsor in the design, setting up or running of the study).
    20. Concurrent participation in any other clinical study, including noninterventional studies.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage change in EASI from Baseline to Day 113.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 113
    E.5.2Secondary end point(s)
    -Safety endpoints:
    •Incidence of treatment emergent adverse events including AESIs.
    -Pharmacokinetic endpoints:
    •Serum KY1005 concentration assessed throughout the study for each patient (receiving KY1005).
    -Key secondary efficacy endpoints:
    •Percentage change from Baseline in EASI at Day 169.(Week 24).
    •Percentage of patients with at least a 75% reduction from Baseline in EASI (EASI 75) at Days 113 (Week 16) and 169 (Week 24).
    •Percentage of patients with a response of IGA 0 or 1 and a reduction from Baseline of ≥2 points at Days 113 (Week 16) and 169 (Week 24).
    •Proportion of patients with improvement (reduction) of weekly average of pruritus NRS ≥4 with a Baseline pruritis NRS of ≥4 from Baseline to Days113 (Week 16) and 169.(Week 24).
    -Other secondary efficacy endpoints:
    •Absolute change from Baseline in EASI at Days15,(Week 2),29,(Week 4),57,(Week 8),85,(Week 12),113,(Week 16),141 (Week 20) and 169 (Week24).
    •Percentage change from Baseline in EASI at Days 15,(Week 2),29,(Week4),57,(Week 8),85 (Week 12) and 141 (Week 20).
    •Percentage of patients with at least a 50% reduction from Baseline in EASI (EASI 50) at Days 15 (Week 2),29,(Week 4),57,(Week 8),85,(Week 12),113,(Week 16),141 (Week 20) and 169 (Week 24).
    •Percentage of patients with at least a 75% reduction from Baseline in EASI (EASI 75) at Days 15 (Week 2),29,(Week 4),57,(Week 8),85 (Week 12) and 141 (Week 20).
    •Percentage of patients with at least a 90% reduction from Baseline in EASI (EASI 90) at Days 15,(Week 2),29,(Week 4),57,(Week 8),85,(Week 12),113,(Week 16),141 (Week 20) and 169 (Week 24).
    •Percentage of patients with a 100% reduction from Baseline in EASI (EASI100) at Days 15,(Week 2),29,(Week 4),57,(Week 8),85,(Week 12),113,(Week 16),141 (Week 20) and 169 (Week 24).
    •Change in IGA from Baseline to Day113 (Week 16) and over time.
    •Percentage of patients with a response of IGA 0 or 1 and a reduction from Baseline of ≥2 points at Days 15,(Week 2),29,(Week 4),57,(Week 8),85(Week 12)and 141 (Week 20).
    •Absolute and percentage change in SCORAD Index from Baseline to Day169 (Week 24) and over time.
    •Absolute and Percentage change in affected BSA from Baseline to Day169 (Week 24) and over time.
    •Absolute and Percentage change in POEM from Baseline to Day169 (Week24) and over time.
    •Absolute and Percentage change in DLQI from Baseline to Day169 (Week24) and over time.
    •Absolute and Percentage change in ADCT from Baseline to Day169 (Week24)and over time.
    •Absolute and Percentage change in HADS from Baseline to Day169(Week24)and over time.
    •Absolute and Percentage change in weekly average of pruritus NRS from Baseline to Day 169 (Week 24) and over time.
    •Proportion of patients with improvement (reduction) of weekly average of pruritus NRS ≥3 with a Baseline pruritis NRS of ≥3 from Baseline to Days113 (Week 16) and 169 (Week 24).
    -PD endpoints:
    •Anti-KY1005 antibody titre and number of patients with positive response.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Safety endpoint: TEAEs & AESIs throughout study. -PK endpoint: Serum KY1005 conc throughout study.
    -Key secondary efficacy endpoints:
    • % change from Baseline in EASI at Days 169.
    • %age of patients with EASI-75 at Days 113 and 169.
    • % of patients with IGA 0 or 1 & a reduction from Baseline of ≥ 2 points at Days 113 & 169.
    • Proportion of patients with improvement weekly average of pruritus NRS ≥ 4 with Baseline pruritis NRS of ≥ 4 from Baseline to Days 113 and 169.
    -Other secondary efficacy endpoints: See above Section E.5.2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E. description
    Other doses and dose schedules KY1005
    E.8.2.4Number of treatment arms in the trial5
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last subjects last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 335
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 213
    F.4.2.2In the whole clinical trial 350
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients who do not achieve ≥ EASI-75 or IGA 0/1 may have the possibility to enter a long term extension study (KY1005-CT06) LTE at Day 169; Patients who lose clinical response at or after
    Week 28 may have the possibility to enter the LTE; If after completion to Week 52 during safety follow-up or after the end of study, patients experience worsening of their AD, may be considered for enrolment in the LTE (subject to meeting inclusion/exclusion criteria)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-05
    P. End of Trial
    P.End of Trial StatusOngoing
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