Dermatitis, AtopicPhase 2NCT01497119
A Study of JNJ-39758979 in Adult Japanese Patients With Moderate Atopic Dermatitis
A Phase 2 study testing JNJ-39758979, 300 mg and JNJ-39758979, 100 mg in people with Dermatitis, Atopic, run by Janssen Pharmaceutical K.K. at 13 sites in Japan.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of JNJ-39758979 in adult Japanese patients with moderate, active atopic dermatitis. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- JNJ-39758979, 300 mg and JNJ-39758979, 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 13 sitesJapan
- Study dates
- Oct 2011to Feb 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of atopic dermatitis based on the criteria of the Japanese Dermatological Association and have: pruritus (itching); eczema-like changes in a typical pattern, and a chronic or chronically relapsing course.
- Childhood onset (under age of 13) of atopic dermatitis.
- Diagnosis of moderate atopic dermatitis based on the Rajka Langeland score between 4.5 and 7.5, inclusive.
- Have at least 3 ratings of "Moderate itching", "Severe itching", or "Extremely severe itching" either at night or during the day based on the Pruritus Categorical Response Scale (PCRS) in the 7 days prior to randomization.
- Atopic dermatitis with 10% to 50% (inclusive) Body Surface Area (BSA) involvement.
Who cannot join
- Have current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled in the Investigator's opinion. Patients with well controlled asthma, allergic rhinitis, or allergic conjunctivitis are allowed to participate. Atopic dermatitis patients with other chronic conditions will not be excluded if the Investigator has determined that the condition is not severe or progressive and is being controlled with stable therapy.
- Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study agent).
- Evidence of any other skin condition that, in the opinion of the Investigator, would interfere with the assessment of atopic dermatitis.
- Use of non-steroid immunosuppressive or immunomodulatory agents within 4 weeks of randomization, including cyclosporine A, azathioprine, mycophenolate mofetil, and interferon gamma.
- Use of systemic corticosteroids within 4 weeks of randomization.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Japan13 sites
Study site
Chitose
Study site
Dazaifu
Study site
Ebetsu
Study site
Eniwa
Study site
Fukuoka
Study site
Kasuga
Study site
Matsudo
Study site
Saitama
Study site
Sapporo
Study site
Setagaya City
Study site
Tokyo
Study site
Utsunomiya
Study site
Yokohama
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-39758979 in Adult Japanese Subjects With Moderate Atopic Dermatitis
The purpose of this study is to evaluate the safety, tolerability, and efficacy of JNJ-39758979 in adult Japanese patients with moderate, active atopic dermatitis.
Read the detailed description
This is a randomized (treatment assigned by chance), double-blind (patient and investigator will not know what treatment is being given), multicenter, parallel-group, exploratory study in adult Japanese patients with moderate atopic dermatitis. This study will include 3 phases. In the screening phase, patients' eligibility will be determined. During the treatment phase, eligible patients will receive JNJ-39758979, 300 or 100 mg once daily, or placebo (a treatment that looks like JNJ-39758979, but contains no active agent) for up to 6 weeks. Study visits will occur at the end of Weeks 1, 2, 4, and 6. There will be a follow-up visit 4 weeks after dosing is complete. The duration of participation in the study for an individual patient may be up to 14 weeks (including screening). Patient safety will be monitored throughout the study.
- Conditions
- Dermatitis, Atopic
- Being tested
- JNJ-39758979, 300 mg, JNJ-39758979, 100 mg, Placebo
- Keywords
- Moderate atopic dermatitis, JNJ-39758979, Japanese patients
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-39758979, 300 mgDrug
Type=exact number, unit=mg, number=300, form=tablet, route=oral use, once daily for 6 weeks.
JNJ-39758979, 100 mgDrug
Type=exact number, unit=mg, number=100, form=tablet, route=oral use, once daily for 6 weeks.
PlaceboDrug
Form=tablet, route=oral use, once daily for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-39758979, 300 mg | Experimental | Not described Receives: Drug: JNJ-39758979, 300 mg |
| JNJ-39758979, 100 mg | Experimental | Not described Receives: Drug: JNJ-39758979, 100 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring of clinical laboratory tests
Assessments of blood, serum, and urine as a meaure of safety
Measured: Up to approximately 14 weeks
The number of adverse events
As a measure of safety
Measured: Up to approximately 14 weeks
Monitoring of electrocardiograms
As a measure of safety
Measured: Up to approximately 14 weeks
Monitoring of vital signs tests
Blood pressure and pulse as a measure of safety
Measured: Up to approximately 14 weeks
EASI (Eczema Area and Severity Index) score
A measure of the severity and extent of atopic dermatitis
Measured: Up to approximately 14 weeks
Monitoring of physical examination assessments
Including height and body weight, as a measure of safety
Measured: Up to 10 weeks
Secondary outcomes (5)
Investigator's Global Assessment (IGA)
A 6-point scale that ranges from 0 (clear) to 5 (very severe disease).
Measured: Up to approximately 14 weeks
Pruritus Categorical Response Scale (PCRS)
A 5-point categorical response scale where the response options range from "no itching" to "extremely severe itching."
Measured: Up to approximately 14 weeks
Pruritus Numeric Rating Scales (PNRS)
An 11-point (0 to 10) numeric rating scale.
Measured: Up to approximately 14 weeks
Pruritus Interference Numeric Rating Scale (PINRS)
An 11-point numerical rating scale of 0 to 10, where 0 = "Did Not Interfere" and 10 = "Completely Interfered."
Measured: Up to approximately 14 weeks
Subject's Global Impressions of Change in Pruritus (SGICP)
A 7-point scale ranging from "a lot more now" to " a lot less now" with a neutral center point ("neither more nor less").
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: This study was terminated prematurely due to 2 cases of agranulocytosis.
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutical K.K., Japan Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497119
- Sponsor's protocol ID
- CR017455
- Other IDs
- 39758979ADM2001
- Status last verified
- Nov 2015
- First submitted
- 20 Dec 2011
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-39758979 in Adult Japanese Subjects With Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01497119
- Acronym / sponsor ID
- CR017455
- Conditions
- Dermatitis, Atopic
- Keywords
- Moderate atopic dermatitis, JNJ-39758979, Japanese patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated prematurely due to 2 cases of agranulocytosis.
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Dec 2011 (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.
The purpose of this study is to evaluate the safety, tolerability, and efficacy of JNJ-39758979 in adult Japanese patients with moderate, active atopic dermatitis.
Detailed description
This is a randomized (treatment assigned by chance), double-blind (patient and investigator will not know what treatment is being given), multicenter, parallel-group, exploratory study in adult Japanese patients with moderate atopic dermatitis. This study will include 3 phases. In the screening phase, patients' eligibility will be determined. During the treatment phase, eligible patients will receive JNJ-39758979, 300 or 100 mg once daily, or placebo (a treatment that looks like JNJ-39758979, but contains no active agent) for up to 6 weeks. Study visits will occur at the end of Weeks 1, 2, 4, and 6. There will be a follow-up visit 4 weeks after dosing is complete. The duration of participation in the study for an individual patient may be up to 14 weeks (including screening). Patient safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JNJ-39758979, 300 mg | Experimental | Drug: JNJ-39758979, 300 mg |
| JNJ-39758979, 100 mg | Experimental | Drug: JNJ-39758979, 100 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of atopic dermatitis based on the criteria of the Japanese Dermatological Association and have: pruritus (itching); eczema-like changes in a typical pattern, and a chronic or chronically relapsing course.
- Childhood onset (under age of 13) of atopic dermatitis.
- Diagnosis of moderate atopic dermatitis based on the Rajka Langeland score between 4.5 and 7.5, inclusive.
- Have at least 3 ratings of "Moderate itching", "Severe itching", or "Extremely severe itching" either at night or during the day based on the Pruritus Categorical Response Scale (PCRS) in the 7 days prior to randomization.
- Atopic dermatitis with 10% to 50% (inclusive) Body Surface Area (BSA) involvement.
Key exclusion criteria (5 listed)
- Have current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled in the Investigator's opinion. Patients with well controlled asthma, allergic rhinitis, or allergic conjunctivitis are allowed to participate. Atopic dermatitis patients with other chronic conditions will not be excluded if the Investigator has determined that the condition is not severe or progressive and is being controlled with stable therapy.
- Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study agent).
- Evidence of any other skin condition that, in the opinion of the Investigator, would interfere with the assessment of atopic dermatitis.
- Use of non-steroid immunosuppressive or immunomodulatory agents within 4 weeks of randomization, including cyclosporine A, azathioprine, mycophenolate mofetil, and interferon gamma.
- Use of systemic corticosteroids within 4 weeks of randomization.
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 |
|---|---|---|
| JNJ-39758979, 300 mgType=exact number, unit=mg, number=300, form=tablet, route=oral use, once daily for 6 weeks. | Drug | JNJ-39758979, 300 mg |
| JNJ-39758979, 100 mgType=exact number, unit=mg, number=100, form=tablet, route=oral use, once daily for 6 weeks. | Drug | JNJ-39758979, 100 mg |
| PlaceboForm=tablet, route=oral use, once daily for 6 weeks. | Drug | Placebo |
Primary outcome
Monitoring of clinical laboratory tests
Time frame: Up to approximately 14 weeks
Assessments of blood, serum, and urine as a meaure of safety
The number of adverse events
Time frame: Up to approximately 14 weeks
As a measure of safety
Monitoring of electrocardiograms
Time frame: Up to approximately 14 weeks
As a measure of safety
Monitoring of vital signs tests
Time frame: Up to approximately 14 weeks
Blood pressure and pulse as a measure of safety
EASI (Eczema Area and Severity Index) score
Time frame: Up to approximately 14 weeks
A measure of the severity and extent of atopic dermatitis
Monitoring of physical examination assessments
Time frame: Up to 10 weeks
Including height and body weight, as a measure of safety
5 secondary outcomes
Investigator's Global Assessment (IGA)
Time frame: Up to approximately 14 weeks
Pruritus Categorical Response Scale (PCRS)
Time frame: Up to approximately 14 weeks
Pruritus Numeric Rating Scales (PNRS)
Time frame: Up to approximately 14 weeks
Pruritus Interference Numeric Rating Scale (PINRS)
Time frame: Up to approximately 14 weeks
Subject's Global Impressions of Change in Pruritus (SGICP)
Time frame: Up to 10 weeks
Results and safety
The study was stopped early (reason given: This study was terminated prematurely due to 2 cases of agranulocytosis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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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.
Janssen Pharmaceutical K.K., Japan Clinical Trial study director
Janssen Pharmaceutical K.K.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-39758979, 300 mg and JNJ-39758979, 100 mg in people with Dermatitis, Atopic, run by Janssen Pharmaceutical K.K. at 13 sites 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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 was stopped early (reason given: This study was terminated prematurely due to 2 cases of agranulocytosis.). Results are not available in the source record.
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?
Monitoring of clinical laboratory tests (time frame: Up to approximately 14 weeks). The study lists 6 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 2 Dec 2015.