Atopic DermatitisPhase 2NCT03703102
Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing KHK4083 in people with Atopic Dermatitis, run by Kyowa Kirin, Inc. at 58 sites in 4 countries.
Trial summary
A Phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group study for subjects with moderate to severe AD whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- KHK4083
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 58 sitesin 4 countries
- Study dates
- 22 Oct 2018to 12 Nov 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signed informed consent to participate in the study;
- Chronic AD, according to American Academy of Dermatology Consensus Criteria or the local diagnostic criteria, that has been present for at least 1 year before screening;
- EASI score ≥16 at screening and baseline;
- IGA score ≥3 (moderate) at both screening and baseline;
- BSA ≥10% at both screening and baseline;
- Documented recent history (within 1 year prior to screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).
Who cannot join
- Current or past history of clinically significant illness(es) deemed by the Investigator to be likely to affect the study conduct and assessments. Examples include, but are not limited to, clinically significant cardiovascular (e.g., New York Heart Association [NYHA] Class III or IV), uncontrolled diabetes (HbA1c ≥9%), liver (e.g., Child-Pugh class B or C), renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders;
- Any of the following laboratory abnormalities at screening:
- Serum creatinine: >1.5 mg/dL
- AST or ALT: ≥2.5 times the upper limit of normal (ULN)
- Neutrophil count: <1.5×10³/μL
- Other laboratory abnormalities that may affect the completion or evaluation of the study, as judged by the Investigator;
- Active malignancies, or onset or a history of treatment of malignancies within 5 years prior to informed consent (except curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma).
Trial locations and contacts
58 sites in 4 countries.
58 sites in 4 countries
Japan31 sites
Kyowa Investigational Site JP-17
Aichi
Kyowa Investigational Site JP-27
Aichi
Kyowa Investigational Site JP-24
Chiba
Kyowa Investigational Site JP-08
Fukuoka
Kyowa Investigational Site JP-09
Fukuoka
Kyowa Investigational Site JP-12
Fukuoka
Kyowa Investigational Site JP-19
Fukuoka
Kyowa Investigational Site JP-26
Fukuoka
Kyowa Investigational Site JP-14
Gifu
Kyowa Investigational Site JP-01
Hokkaido
Kyowa Investigational Site JP-02
Hokkaido
Kyowa Investigational Site JP-04
Hokkaido
Kyowa Investigational Site JP-29
Hokkaido
Kyowa Investigational Site JP-31
Ibaraki
Kyowa Investigational Site JP-10
Kagoshima
Kyowa Investigational Site JP-11
Kagoshima
Kyowa Investigational Site JP-05
Kanagawa
Kyowa Investigational Site JP-06
Kanagawa
Kyowa Investigational Site JP-21
Kanagawa
Kyowa Investigational Site JP-18
Mie
Kyowa Investigational Site JP-20
Miyagi
Kyowa Investigational Site JP-28
Morioka
Kyowa Investigational Site JP-25
Shimane
Kyowa Investigational Site JP-15
Tochigi
Kyowa Investigational Site JP-03
Tokyo
Kyowa Investigational Site JP-07
Tokyo
Kyowa Investigational Site JP-13
Tokyo
Kyowa Investigational Site JP-16
Tokyo
Kyowa Investigational Site JP-22
Tokyo
Kyowa Investigational Site JP-23
Tokyo
Kyowa Investigational Site JP-30
Tokyo
United States13 sites
Kyowa Investigational Site US-10
Aurora, Colorado, 80010
Kyowa Investigational Site US-04
Boston, Massachusetts, 02115
Kyowa Investigational Site US-20
Charlotte, North Carolina, 28277
Kyowa Investigational Site US-14
Clearwater, Florida, 33756
Kyowa Investigational Site US-11
Cleveland, Ohio, 44106
Kyowa Investigational Site US-02
Dallas, Texas, 75230
Kyowa Investigational Site US-07
Galveston, Texas, 77555
Kyowa Investigational Site US-19
Huntington Beach, California, 92647
Kyowa Investigational Site US-17
Irvine, California, 92697
Kyowa Investigational Site US-09
Los Angeles, California, 90033
Kyowa Investigational Site US-01
New York, New York, 10029
Kyowa Investigational Site US-08
Portland, Oregon, 97239
Kyowa Investigational Site US-05
Santa Ana, California, 92701
Germany8 sites
Kyowa Investigational Site GE-13
Aachen
Kyowa Investigational Site GE-07
Berlin
Kyowa Investigational Site GE-14
Berlin
Kyowa Investigational Site GE-08
Darmstadt
Kyowa Investigational Site GE-05
Frankfurt am Main
Kyowa Investigational Site GE-02
Hamburg
Kyowa Investigational Site GE-11
Hanover
Kyowa Investigational Site GE-01
Langenau
Canada6 sites
Kyowa Investigational Site CA-02
Markham, Ontario
Kyowa Investigational Site CA-07
Québec, Quebec
Kyowa Investigational Site CA-09
Québec, Quebec
Kyowa Investigational Site CA-03
Richmond Hill, Ontario
Kyowa Investigational Site CA-08
Richmond Hill, Ontario
Kyowa Investigational Site CA-04
Sherbrooke, Quebec
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis (AD)
A Phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group study for subjects with moderate to severe AD whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable.
- Conditions
- Atopic Dermatitis
- Being tested
- KHK4083, Placebo
- Keywords
- AD, eczema, skin diseases, biologics
- Medical subject headings
- Dermatitis, Atopic, Eczema, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHK4083Drug
Anti-OX40 Monoclonal Antibody KHK4083
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Placebo comparator | Subcutaneous administration of placebo Receives: Drug: Placebo |
| Arm B | Experimental | Subcutaneous administration of KHK4083 (dose level 1, dosing regimen 2) Receives: Drug: KHK4083 |
| Arm C | Experimental | Subcutaneous administration of KHK4083 (dose level 2, dosing regimen 1) Receives: Drug: KHK4083 |
| Arm D | Experimental | Subcutaneous administration of KHK4083 (dose level 3, dosing regimen 1) Receives: Drug: KHK4083 |
| Arm E | Experimental | Subcutaneous administration of KHK4083 (dose level 3, dosing regimen 2) Receives: Drug: KHK4083 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Measured: Baseline to Week 16
Secondary outcomes (23)
Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Measured: Baseline to Week 16
Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Measured: Baseline to Week 16
Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
Measured: Baseline to Week 16
Percent Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
Measured: Baseline to Week 16
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Week 16
In the IGA, the Investigator will evaluate the overall skin symptoms of subjects at each visit on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: Baseline to Week 16
Change From Baseline to Week 16 in Percent Body Surface Area of Involvement of AD (BSA)
The Investigator will calculate the percentage (%) of the total body surface area affected by AD.
Measured: Baseline to Week 16
Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."
Measured: Baseline to Week 16
Percent Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."
Measured: Baseline to Week 16
Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Measured: Baseline to Week 16
Percent Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Measured: Baseline to Week 16
Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI)
DLQI consists of 6 subscales (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment), which are scored from 0 to 3 on the basis of 10 questions. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more QoL is impaired.
Measured: Baseline to Week 16
EASI Score at Each Time Point
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Measured: 56 Weeks
Percent Change From Baseline in EASI Score at Each Time Point
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Measured: 56 Weeks
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%).
Measured: 56 Weeks
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
Measured: 56 Weeks
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
Measured: 56 Weeks
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
In the IGA, the Investigator will evaluate the overall skin symptoms of subjects at each visit on a 5-point scale ranging from 0 (clear) to 4 (severe)
Measured: 56 Weeks
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
The Investigator will calculate the percentage (%) of the total body surface area affected by AD.
Measured: 56 Weeks
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."
Measured: 56 Weeks
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."
Measured: 56 Weeks
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Measured: 56 Weeks
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Measured: 56 Weeks
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI consists of 6 subscales (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment), which are scored from 0 to 3 on the basis of 10 questions. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more QoL is impaired.
Measured: 56 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start22 Oct 2018
- Primary completion6 Feb 2020
- Study completion12 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies 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
- subcutaneous administration
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Kirin Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Ehsanollah Esfandiari, MD, PhD, Study director, Kyowa Kirin Pharmaceutical International Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703102
- Sponsor's protocol ID
- 4083-006
- Status last verified
- Apr 2024
- First submitted
- 9 Oct 2018
- Last updated
- 26 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gooderham M, Guttman-Yassky E, Igawa K, Kabashima K, Esfandiari E, Rylands AJ, Williams A, Nixon A, Dent JE, Simpson E. Rocatinlimab Improves Patient-Reported Outcomes in Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Double-Blind Placebo-Controlled Phase 2b Study. Dermatol Ther (Heidelb). 2024 Dec;14(12):3351-3366. doi: 10.1007/s13555-024-01303-z. Epub 2024 Nov 12.
PubMed 39532780Guttman-Yassky E, Simpson EL, Reich K, Kabashima K, Igawa K, Suzuki T, Mano H, Matsui T, Esfandiari E, Furue M. An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: a multicentre, double-blind, placebo-controlled phase 2b study. Lancet. 2023 Jan 21;401(10372):204-214. doi: 10.1016/S0140-6736(22)02037-2. Epub 2022 Dec 9.
PubMed 36509097
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis (AD)
- ClinicalTrials.gov ID
- NCT03703102
- Acronym / sponsor ID
- 4083-006
- Conditions
- Atopic Dermatitis
- Keywords
- AD, eczema, skin diseases, biologics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Kyowa Kirin, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Kirin Co., Ltd.
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 6 Feb 2020 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 11 Oct 2018 (actual)
- Results
- Posted 9 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group study for subjects with moderate to severe AD 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- subcutaneous administration
| Arm | Type | Receives |
|---|---|---|
| Arm A | Placebo comparator | Drug: PlaceboSubcutaneous administration of placebo |
| Arm B | Experimental | Drug: KHK4083Subcutaneous administration of KHK4083 (dose level 1, dosing regimen 2) |
| Arm C | Experimental | Drug: KHK4083Subcutaneous administration of KHK4083 (dose level 2, dosing regimen 1) |
| Arm D | Experimental | Drug: KHK4083Subcutaneous administration of KHK4083 (dose level 3, dosing regimen 1) |
| Arm E | Experimental | Drug: KHK4083Subcutaneous administration of KHK4083 (dose level 3, dosing regimen 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily signed informed consent to participate in the study;
- Chronic AD, according to American Academy of Dermatology Consensus Criteria or the local diagnostic criteria, that has been present for at least 1 year before screening;
- EASI score ≥16 at screening and baseline;
- IGA score ≥3 (moderate) at both screening and baseline;
- BSA ≥10% at both screening and baseline;
Key exclusion criteria (7 listed)
- Current or past history of clinically significant illness(es) deemed by the Investigator to be likely to affect the study conduct and assessments. Examples include, but are not limited to, clinically significant cardiovascular (e.g., New York Heart Association [NYHA] Class III or IV), uncontrolled diabetes (HbA1c ≥9%), liver (e.g., Child-Pugh class B or C), renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders;
- Any of the following laboratory abnormalities at screening:
- Active malignancies, or onset or a history of treatment of malignancies within 5 years prior to informed consent (except curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma).
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 |
|---|---|---|
| KHK4083Anti-OX40 Monoclonal Antibody KHK4083 | Drug | Arm B, Arm C, Arm D, Arm E |
| PlaceboMatching placebo | Drug | Arm A |
Primary outcome
Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
Time frame: Baseline to Week 16
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
23 secondary outcomes
Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16
Time frame: Baseline to Week 16
Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
Time frame: Baseline to Week 16
Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score
Time frame: Baseline to Week 16
Percent Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score
Time frame: Baseline to Week 16
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Week 16
Time frame: Baseline to Week 16
Change From Baseline to Week 16 in Percent Body Surface Area of Involvement of AD (BSA)
Time frame: Baseline to Week 16
Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score
Time frame: Baseline to Week 16
Percent Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score
Time frame: Baseline to Week 16
Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score
Time frame: Baseline to Week 16
Percent Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score
Time frame: Baseline to Week 16
Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI)
Time frame: Baseline to Week 16
EASI Score at Each Time Point
Time frame: 56 Weeks
Percent Change From Baseline in EASI Score at Each Time Point
Time frame: 56 Weeks
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Time frame: 56 Weeks
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
Time frame: 56 Weeks
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
Time frame: 56 Weeks
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Time frame: 56 Weeks
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Time frame: 56 Weeks
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Time frame: 56 Weeks
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Time frame: 56 Weeks
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Time frame: 56 Weeks
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Time frame: 56 Weeks
Dermatology Life Quality Index (DLQI) at Each Time Point
Time frame: 56 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39532780Gooderham M, Guttman-Yassky E, Igawa K, Kabashima K, Esfandiari E, Rylands AJ, Williams A, Nixon A, Dent JE, Simpson E. Rocatinlimab Improves Patient-Reported Outcomes in Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Double-Blind Placebo-Controlled Phase 2b Study. Dermatol Ther (Heidelb). 2024 Dec;14(12):3351-3366. doi: 10.1007/s13555-024-01303-z. Epub 2024 Nov 12.
- Derived from this study: PubMed 36509097Guttman-Yassky E, Simpson EL, Reich K, Kabashima K, Igawa K, Suzuki T, Mano H, Matsui T, Esfandiari E, Furue M. An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: a multicentre, double-blind, placebo-controlled phase 2b study. Lancet. 2023 Jan 21;401(10372):204-214. doi: 10.1016/S0140-6736(22)02037-2. Epub 2022 Dec 9.
- Individual participant dataSharing planned: No
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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.
Ehsanollah Esfandiari, MD, PhD study director
Kyowa Kirin Pharmaceutical International Ltd.
58 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 KHK4083 in people with Atopic Dermatitis, run by Kyowa Kirin, Inc. at 58 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 6 inclusion and 7 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 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in Japan, United States, Germany, Canada. 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?
Yes. Results are posted in the registry (first posted 9 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03703102, which also lists 2 linked publications.
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 26 Apr 2024.