Dermatitis, AtopicPhase 2NCT03754309
A Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing KY1005 in people with Dermatitis, Atopic, run by Kymab Limited at 19 sites in 4 countries.
Trial summary
The purpose of this research study is to investigate if KY1005 results in improvement of eczema when given to participants with moderate to severe disease. Side effects of KY1005 will also be explored. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- KY1005
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 19 sitesin 4 countries
- Study dates
- 13 Dec 2018to 8 Oct 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (greater than or equal to [>=] 18 years but less than [<] 75 years of age) with Atopic Dermatitis (AD) for 1 year or longer at Baseline (Day 1; prior to first administration of Investigational Medicinal Product [IMP]).
- Eczema Area and Severity Index (EASI) of 12 or higher at the Screening Visit and 16 or higher at Baseline.
- validated Investigator Global Assessment (vIGA) of 3 or 4 at Baseline.
- AD involvement of 10 percent or more of body surface area at Baseline.
- Documented history, within 6 months prior to Baseline, of either inadequate response to topical treatments 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 at least 7 consecutive days before Baseline.
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- Able and willing to comply with requested study visits/telephone visits and procedures.
- Able and willing to provide punch biopsy of both lesional and non-lesional skin at Baseline.
- Able and willing to provide written informed consent.
Who cannot join
- Recent 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.
- Basal and squamous cell skin cancer in the last 3 years prior to Baseline. Any other malignancies in the last 5 years prior to Baseline (excluding in situ cervical carcinoma).
- Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, renal disease, neurological conditions, heart failure and pulmonary disease.
- Laboratory values at the Screening Visit:
- a. Serum creatinine > 1.6 milligrams per deciliter (mg/dL) (141 micromole per liter [mcmol/L]) in female participants and > 1.9 mg/dL (168 mcmol/L) in male participants;
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- b. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × upper limit of normal (ULN);
- c. Platelet count < 100*10^9/L;
- d. Haemoglobin (Hb): Male < 13.5 g/dL and Female <12 g/dL;
- e. White blood cell count (WBCC) < 3.0*10^9/L;
- f. Absolute neutrophil count < 2.0*10^9/L;
- g. Absolute lymphocyte count < 0.5*10^9/L;
- h. Total bilirubin > ULN.
- Participation in any other clinical study, including non-interventional studies.
Trial locations and contacts
19 sites in 4 countries.
19 sites in 4 countries
Poland11 sites
Kymab investigational site 207
Gdansk
Kymab investigational site 216
Katowice
Kymab investigational site 206
Krakow
Kymab investigational site 212
Krakow
Kymab investigational site 213
Krakow
Kymab investigational site 214
Krakow
Kymab investigational site 203
Olsztyn
Kymab investigational site 210
Poznan
Kymab investigator site 201
Rzeszów
Kymab investigational site 204
Warsaw
Kymab investigational site 202
Wroclaw
Spain4 sites
Kymab investigational site 304
Córdoba
Kymab investigational site 303
Madrid
Kymab investigational site 302
Seville
Kymab investigational site 315
Valencia
Germany2 sites
Kymab investigational site 106
Kiel
Kymab investigational site 113
Leipzig
United Kingdom2 sites
Kymab investigational site 420
Harrogate
Kymab investigational site 402
Sheffield
About this study
Official title: A Phase 2a, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicentre Study of an Anti OX40L Monoclonal Antibody (KY1005) in Moderate to Severe Atopic Dermatitis
The purpose of this research study is to investigate if KY1005 results in improvement of eczema when given to participants with moderate to severe disease. Side effects of KY1005 will also be explored.
Read the detailed description
Phase 2a, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety and tolerability of two doses of KY1005 in adults with moderate to severe atopic dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable.
- Conditions
- Dermatitis, Atopic
- Being tested
- KY1005, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KY1005Drug
Also called SAR445229
A human anti-OX40 ligand monoclonal antibody
PlaceboDrug
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| KY1005 lower dose | Experimental | Low dose KY1005 Receives: Drug: KY1005 |
| KY1005 higher dose | Experimental | High dose KY1005 Receives: Drug: KY1005 |
| Placebo | Placebo comparator | Matched placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in Eczema Area and Severity Index (EASI)
Measured: Baseline to day 113
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Baseline to day 113
Secondary outcomes (14)
Percentage and absolute change from Baseline in EASI over time
Measured: Baseline to day 113
Change in epidermal thickness
Measured: Baseline to day 113
Change in keratin 16 staining of skin biopsies
Measured: Baseline to day 113
Percentage of patients with at least a 50% reduction in EASI (EASI 50)
Measured: Baseline to day 113
Percentage of patients with at least a 75% reduction in EASI (EASI 75)
Measured: Baseline to day 113
Percentage of patients with at least a 90% reduction in EASI (EASI 90)
Measured: Baseline to day 113
Change in Validated Investigator Global Assessment (vIGA)
Measured: Baseline to day 113
Percentage of patients with a response of vIGA 0 or 1
Measured: Baseline to day 113
Change in SCORing of Atopic Dermatis (SCORAD) Index
Measured: Baseline to day 113
Change in affected body surface area (BSA)
Measured: Baseline to day 113
Change in Patient Orientated Eczema Measure (POEM)
Measured: Baseline to Day 113
Change in Patient Orientated SCORing of Atopic Dermatitis (PO-SCORAD) Index
Measured: Baseline to day 113
Change in Dermatology Quality of Life Index (DLQI)
Measured: Baseline to Day 113
Change in Numerical Rating Scale (NRS) for pruritus
Measured: Baseline to day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start13 Dec 2018
- Primary completion12 May 2020
- Study completion8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Primary analysis up to day 113. Long term follow up to day 253 (dependent on response).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kymab Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephan Weidinger, MaHM, Principal investigator, University Hospital Schleswig-Holstein, 24105 Kiel, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754309
- Sponsor's protocol ID
- KY1005-CT02
- Other IDs
- 2018-002299-41, ACT17369, 2018
- Status last verified
- Jan 2023
- First submitted
- 19 Nov 2018
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicentre Study of an Anti OX40L Monoclonal Antibody (KY1005) in Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03754309
- Acronym / sponsor ID
- KY1005-CT02
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Kymab LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to investigate if KY1005 results in improvement of eczema when given to participants with moderate to severe disease. Side effects of KY1005 will also be explored.
Detailed description
Phase 2a, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety and tolerability of two doses of KY1005 in adults with moderate to severe atopic dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Primary analysis up to day 113. Long term follow up to day 253 (dependent on response).
| Arm | Type | Receives |
|---|---|---|
| KY1005 lower dose | Experimental | Drug: KY1005Low dose KY1005 |
| KY1005 higher dose | Experimental | Drug: KY1005High dose KY1005 |
| Placebo | Placebo comparator | Drug: PlaceboMatched placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults (greater than or equal to [>=] 18 years but less than [<] 75 years of age) with Atopic Dermatitis (AD) for 1 year or longer at Baseline (Day 1; prior to first administration of Investigational Medicinal Product [IMP]).
- Eczema Area and Severity Index (EASI) of 12 or higher at the Screening Visit and 16 or higher at Baseline.
- validated Investigator Global Assessment (vIGA) of 3 or 4 at Baseline.
- AD involvement of 10 percent or more of body surface area at Baseline.
- Documented history, within 6 months prior to Baseline, of either inadequate response to topical treatments or inadvisability of topical treatments.
Key exclusion criteria (14 listed)
- Recent 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.
- Basal and squamous cell skin cancer in the last 3 years prior to Baseline. Any other malignancies in the last 5 years prior to Baseline (excluding in situ cervical carcinoma).
- Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, renal disease, neurological conditions, heart failure and pulmonary disease.
- Laboratory values at the Screening Visit:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KY1005Also: SAR445229A human anti-OX40 ligand monoclonal antibody | Drug | KY1005 higher dose, KY1005 lower dose |
| PlaceboMatched placebo | Drug | Placebo |
Primary outcome
Percentage change in Eczema Area and Severity Index (EASI)
Time frame: Baseline to day 113
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Baseline to day 113
14 secondary outcomes
Percentage and absolute change from Baseline in EASI over time
Time frame: Baseline to day 113
Change in epidermal thickness
Time frame: Baseline to day 113
Change in keratin 16 staining of skin biopsies
Time frame: Baseline to day 113
Percentage of patients with at least a 50% reduction in EASI (EASI 50)
Time frame: Baseline to day 113
Percentage of patients with at least a 75% reduction in EASI (EASI 75)
Time frame: Baseline to day 113
Percentage of patients with at least a 90% reduction in EASI (EASI 90)
Time frame: Baseline to day 113
Change in Validated Investigator Global Assessment (vIGA)
Time frame: Baseline to day 113
Percentage of patients with a response of vIGA 0 or 1
Time frame: Baseline to day 113
Change in SCORing of Atopic Dermatis (SCORAD) Index
Time frame: Baseline to day 113
Change in affected body surface area (BSA)
Time frame: Baseline to day 113
Change in Patient Orientated Eczema Measure (POEM)
Time frame: Baseline to Day 113
Change in Patient Orientated SCORing of Atopic Dermatitis (PO-SCORAD) Index
Time frame: Baseline to day 113
Change in Dermatology Quality of Life Index (DLQI)
Time frame: Baseline to Day 113
Change in Numerical Rating Scale (NRS) for pruritus
Time frame: Baseline to day 113
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Weidinger, MaHM principal investigator
University Hospital Schleswig-Holstein, 24105 Kiel, Germany
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KY1005 in people with Dermatitis, Atopic, run by Kymab Limited at 19 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Poland, Spain, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in Eczema Area and Severity Index (EASI) (time frame: Baseline to day 113). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.