Dermatitis, AtopicPhase 1NCT03096223
A Phase 1 Study of KHK4083 in Subjects With Atopic Dermatitis
A Phase 1 study testing KHK4083 in people with Dermatitis, Atopic, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
The objective of this study is to evaluate the safety and tolerability of multiple intravenous (IV) infusions of KHK4083 in subjects with moderate or severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- KHK4083
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteJapan
- Study dates
- 10 Apr 2017to 7 Feb 2018
- Phase
- Phase 1
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary written informed consent to participate in the study
- Atopic dermatitis diagnosed according to the Definition and Diagnostic Criteria for Atopic Dermatitis (Guidelines for Management of Atopic Dermatitis 2016) established by the Japanese Dermatological Association
- Moderate or severe (≥4.5) symptoms of atopic dermatitis at screening, according to the Rajka \& Langeland Severity Index
- Investigator Global Assessment(IGA) ≥3 (moderate) at screening
Who cannot join
- Any of the following clinically significant concurrent illnesses:
- Type 1 diabetes
- Poorly controlled type 2 diabetes (HbA1c >8.5%)
- Congestive heart failure (class II to IV of the New York Heart Association classification)
- Myocardial infarction within 1 year
- Unstable angina pectoris within 1 year
Show all 17Show fewer
- Poorly controlled hypertension (systolic pressure >150 mm Hg or diastolic pressure >90 mm Hg at screening)
- Severe chronic lung diseases requiring oxygen therapy
- Multiple sclerosis or other demyelinating diseases
- Active malignancies, or onset or a history of treatment of malignancies within 5 years prior to informed consent (except for resected or surgically cured epithelial carcinoma of the uterine cervix, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or ductal carcinoma)
- Current or past history of clinically significant cardiovascular, liver, renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders other than those in 1)
- Alcohol dependence, or drug dependence or a positive result for any of the drug abuse test items
- Past or current history of drug allergy
- Any clinically significant infection requiring hospitalization or IV administration of antibiotics within 8 weeks prior to pre-enrollment
- Any planned surgical treatment during the study
- Any skin disease that may affect the clinical symptom assessment
- Pregnant or lactating women, or women willing to have a child during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Multiple-Dose Study of KHK4083 in Subjects With Atopic Dermatitis
The objective of this study is to evaluate the safety and tolerability of multiple intravenous (IV) infusions of KHK4083 in subjects with moderate or severe atopic dermatitis.
- Conditions
- Dermatitis, Atopic
- Being tested
- KHK4083
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHK4083Drug
IV administration
| Study group | Role | What they receive |
|---|---|---|
| KHK4083 | Experimental | Not described Receives: Drug: KHK4083 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature
Measured: Up to 22 weeks post drug administration
Secondary outcomes (5)
Serum KHK4083 concentration
Measured: Up to 22 weeks post drug administration
Maximum concentration (Cmax)
Measured: Up to 22 weeks post drug administration
Time to reach Cmax (tmax)
Measured: Up to 22 weeks post drug administration
Area under the curve (AUC)
Measured: Up to 22 weeks post drug administration
Anti-KHK4083 antibody production
Measured: Up to 22 weeks post drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start10 Apr 2017
- Primary completion7 Feb 2018
- Study completion7 Feb 2018
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.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096223
- Sponsor's protocol ID
- 4083-004
- Status last verified
- Mar 2018
- First submitted
- 23 Mar 2017
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multiple-Dose Study of KHK4083 in Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03096223
- Acronym / sponsor ID
- 4083-004
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 7 Feb 2018 (actual)
- Study completion
- 7 Feb 2018 (actual)
- First posted
- 30 Mar 2017 (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 objective of this study is to evaluate the safety and tolerability of multiple intravenous (IV) infusions of KHK4083 in subjects with moderate or severe atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KHK4083 | Experimental | Drug: KHK4083 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntary written informed consent to participate in the study
- Atopic dermatitis diagnosed according to the Definition and Diagnostic Criteria for Atopic Dermatitis (Guidelines for Management of Atopic Dermatitis 2016) established by the Japanese Dermatological Association
- Moderate or severe (≥4.5) symptoms of atopic dermatitis at screening, according to the Rajka \& Langeland Severity Index
- Investigator Global Assessment(IGA) ≥3 (moderate) at screening
Key exclusion criteria (17 listed)
- Any of the following clinically significant concurrent illnesses:
- Current or past history of clinically significant cardiovascular, liver, renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders other than those in 1)
- Alcohol dependence, or drug dependence or a positive result for any of the drug abuse test items
- Past or current history of drug allergy
- Any clinically significant infection requiring hospitalization or IV administration of antibiotics within 8 weeks prior to pre-enrollment
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 |
|---|---|---|
| KHK4083IV administration | Drug | KHK4083 |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature
Time frame: Up to 22 weeks post drug administration
5 secondary outcomes
Serum KHK4083 concentration
Time frame: Up to 22 weeks post drug administration
Maximum concentration (Cmax)
Time frame: Up to 22 weeks post drug administration
Time to reach Cmax (tmax)
Time frame: Up to 22 weeks post drug administration
Area under the curve (AUC)
Time frame: Up to 22 weeks post drug administration
Anti-KHK4083 antibody production
Time frame: Up to 22 weeks post drug administration
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 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KHK4083 in people with Dermatitis, Atopic, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
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 4 inclusion and 17 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 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature (time frame: Up to 22 weeks post drug administration). 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 Mar 2018.