Atopic DermatitisPhase 2NCT02004119
Phase 2 Study of KHK4577
A Phase 2 study testing KHK4577 in people with Atopic Dermatitis, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
This study is an randomized double-blind placebo-controlled study to evaluate the efficacy and the safety of oral KHK4577 for 6 weeks in patients with atopic dermatitis. Pharmacokinetics of KHK4577 will also be assessed. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- KHK4577
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2013to Dec 2014
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject has signed voluntarily the written informed consent form to participate in this study.
- Subject has been diagnosed as atopic dermatitis according to Guidelines for Management of Atopic Dermatitis (2009).
- Rajka \& Langeland criteria of >/= 4.5 at screening visit
- Investigator's Global Assessment (IGA) score of >/= 3 at screening visit
Who cannot join
- Evidence of skin disorders/conditions that would interfere with the assessment of the effect of the study drug.
- Subject received photochemotherapy or systemic immunosuppressants within 2 weeks prior to informed consent.
- Subject has any active infectious disease(except localized infection) which needs to treat with systemic antibiotics(eg. antibacterial, antifungal or antiviral drugs) within 4 weeks prior to informed consent.
- Subject has complications / history of drug abuse or alcoholism.
- Subject has drug allergy or history of allergic reaction to a drug medicine.
- Subject has a significant concurrent medical conditions as defined in the study protocol.
- Subject is breast-feeding, pregnant or planning to become pregnant in this study period.
Trial locations and contacts
1 site in 1 country.
Japan1 site
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Sapporo, Hokkaido, 060-0063
About this study
Official title: Randomized Double-blind Placebo-controlled Study of KHK4577 in Patients With Atopic Dermatitis
This study is an randomized double-blind placebo-controlled study to evaluate the efficacy and the safety of oral KHK4577 for 6 weeks in patients with atopic dermatitis. Pharmacokinetics of KHK4577 will also be assessed.
- Conditions
- Atopic Dermatitis
- Being tested
- KHK4577, 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.
KHK4577Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| KHK4577 | Experimental | Not described Receives: Drug: KHK4577 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent improvement from baseline in Eczema Area and Severity Index (EASI)
Measured: Pre-dose, Week 1,2,4 and 6
Secondary outcomes (5)
Change from baseline in Investigator's Global Assessment score
Measured: Pre-dose, Week 1,2,4 and 6
Dermatology Life Quality Index
Measured: Pre-dose, Week 1,2,4 and 6
Visual Analog Scale (itching)
Measured: Pre-dose, Week 1,2,4 and 6
Incidence of patients with adverse events
Measured: From Day 1 through Week 6
Profile of pharmacokinetics of plasma KHK4577 concentration
Measured: pre-dose, Week 1,2,4 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 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
- NCT02004119
- Sponsor's protocol ID
- 4577-002
- Status last verified
- Aug 2018
- First submitted
- 3 Dec 2013
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Placebo-controlled Study of KHK4577 in Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02004119
- Acronym / sponsor ID
- 4577-002
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Dec 2013 (estimated)
- 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.
This study is an randomized double-blind placebo-controlled study to evaluate the efficacy and the safety of oral KHK4577 for 6 weeks in patients with atopic dermatitis. Pharmacokinetics of KHK4577 will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| KHK4577 | Experimental | Drug: KHK4577 |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject has signed voluntarily the written informed consent form to participate in this study.
- Subject has been diagnosed as atopic dermatitis according to Guidelines for Management of Atopic Dermatitis (2009).
- Rajka \& Langeland criteria of >/= 4.5 at screening visit
- Investigator's Global Assessment (IGA) score of >/= 3 at screening visit
Key exclusion criteria (7 listed)
- Evidence of skin disorders/conditions that would interfere with the assessment of the effect of the study drug.
- Subject received photochemotherapy or systemic immunosuppressants within 2 weeks prior to informed consent.
- Subject has any active infectious disease(except localized infection) which needs to treat with systemic antibiotics(eg. antibacterial, antifungal or antiviral drugs) within 4 weeks prior to informed consent.
- Subject has complications / history of drug abuse or alcoholism.
- Subject has drug allergy or history of allergic reaction to a drug medicine.
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 |
|---|---|---|
| KHK4577 | Drug | KHK4577 |
| Placebo | Drug | Placebo |
Primary outcome
Percent improvement from baseline in Eczema Area and Severity Index (EASI)
Time frame: Pre-dose, Week 1,2,4 and 6
5 secondary outcomes
Change from baseline in Investigator's Global Assessment score
Time frame: Pre-dose, Week 1,2,4 and 6
Dermatology Life Quality Index
Time frame: Pre-dose, Week 1,2,4 and 6
Visual Analog Scale (itching)
Time frame: Pre-dose, Week 1,2,4 and 6
Incidence of patients with adverse events
Time frame: From Day 1 through Week 6
Profile of pharmacokinetics of plasma KHK4577 concentration
Time frame: pre-dose, Week 1,2,4 and 6
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 11 Sep 2018.
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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 2 study testing KHK4577 in people with Atopic Dermatitis, 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 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 11 Sep 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. 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?
Percent improvement from baseline in Eczema Area and Severity Index (EASI) (time frame: Pre-dose, Week 1,2,4 and 6). 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 11 Sep 2018.