Atopic DermatitisPhase 2NCT02068352

A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis

A Phase 2 study testing OPA-15406 in people with Atopic Dermatitis, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 30 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate the effectiveness and safety of 2 concentrations of OPA-15406 compared to vehicle in participants with atopic dermatitis (AD). Read more about this study

Who is it for?: Ages 10 to 70 years
Conditions the study is for: Atopic Dermatitis
What is being tested?: OPA-15406
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 121 participants
Where: 30 sitesin 3 countries
Study dates: 20 Jun 2014to 3 Feb 2015
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 10 to 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Participants 10-70 years of age
Diagnosis of AD
History of AD for at least 3 years
AD affecting greater than or equal to 5% and less than or equal to 40% of total body surface area (BSA) at Baseline
Investigator's Global Assessment of Disease Severity score of 2 (mild) or 3 (moderate) in the selected treatment area(s)

Who cannot join

Contact or atopic dermatitis flare within 28 days of the Baseline (Day 1) visit.
Concurrent diseases/conditions and history of other diseases/conditions in the selected treatment area(s) that may have an impact on the study assessments.

Trial locations and contacts

30 sites in 3 countries.

Country

City, postcode or hospital

30 sites in 3 countries

United States20 sites

Study site
Albuquerque, New Mexico, 87106
Study site
Ann Arbor, Michigan, 48109
Study site
Arlington Heights, Illinois, 60005
Study site
Austin, Texas, 78759
Study site
Carmel, Indiana, 46032
Study site
College Station, Texas, 77845
Study site
Denver, Colorado, 80220
Study site
High Point, North Carolina, 27262
Study site
Houston, Texas, 77065
Study site
Los Angeles, California, 90045
Study site
Norfolk, Virginia, 23507
Study site
Orange Park, Florida, 32065
Study site
Portland, Oregon, 97239-4501
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92123
Study site
Spokane, Washington, 99204
Study site
Stony Brook, New York, 11790
Study site
Tampa, Florida, 33613
Study site
Verona, New Jersey, 07044
Study site
West Palm Beach, Florida, 33401

Other trials in United States

Australia5 sites

Study site
Fremantle, Western Australia
Study site
Hectorville, South Australia, 5073
Study site
Kogarah, New South Wales
Study site
Phillip, Australian Capital Territory
Study site
Woolloongabba, Queensland

Other trials in Australia

Poland5 sites

Study site
Katowice
Study site
Krakow
Study site
Lodz
Study site
Warsaw
Study site
Wroclaw

Other trials in Poland

About this study

Official title: A Phase 2 Multi-center, Randomized, Double-blind, Vehicle-controlled, Three-arm, Parallel Group Study to Assess the Safety, Tolerability, and Efficacy of Topical OPA-15406 Ointment, in Subjects With Mild/Moderate Atopic Dermatitis

The purpose of this study is to investigate the effectiveness and safety of 2 concentrations of OPA-15406 compared to vehicle in participants with atopic dermatitis (AD).

Read the detailed description

AD is a disease mainly characterized by pruritic eczema, and those with the disease experience repeated exacerbations and remissions. Therapeutic guidelines for the disease, currently being developed in many countries, all recognize AD as chronic eczema that is accompanied by the physiological dysfunction of the skin and in which inflammation is caused by various nonspecific stimuli or specific allergens. OPA 15406 is a type-4 phosphodiesterase (PDE4) inhibitor. PDE4 inhibitors are thought to be useful for allergic inflammatory diseases. This is a Phase 2 dose ranging study to evaluate the efficacy of two concentrations of OPA 15406 ointment compared to vehicle, when administered topically twice daily in participants with mild to moderate AD.

Conditions: Atopic Dermatitis
Being tested: OPA-15406, Vehicle ointment
Keywords: Atopic Dermatitis, Eczema
Medical subject headings: Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OPA-15406Drug
OPA-15406 topical ointment
Vehicle ointmentDrug
OPA-15406 1%-matching placebo topical ointment

Study groups in NCT02068352
Study group	Role	What they receive
0.3% OPA-15406	Experimental	OPA-15406 0.3% ointment was applied topically twice daily (BID) to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. Receives: Drug: OPA-15406
1% OPA-15406	Experimental	OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. Receives: Drug: OPA-15406
Vehicle Ointment	Placebo comparator	OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. Receives: Drug: Vehicle ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Success in the Overall Investigator's Global Assessment of Disease Severity (IGA) Score at Week 4 [Using Non-responder Imputation or Last Observation Carried Forward (LOCF)]
The IGA evaluation was performed by a certified rater. The IGA score, used to assess the overall disease severity, consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. The IGA assessment was performed for the overall selected treatment area(s): overall percentage body surface area to be treated and additionally for the target lesion. Success was defined as a score of 0 or 1 with at least a 2-grade reduction from Baseline. Participants without IGA score at Week 4 were treated as non-responders. In the sensitivity analysis, missing IGA score at Week 4 was imputed using LOCF method first and the success was defined based on the imputed IGA score.
Measured: Week 4

Secondary outcomes (3)

Change From Baseline in Overall IGA Score at Week 4 [Using Mixed Model Repeated Measures (MMRM) Analysis]
The IGA evaluation was performed by a certified rater. The IGA allows for an assessment of overall disease severity at a given time point, and it consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. The IGA assessment was performed for the overall selected treatment area(s): overall percentage body surface area to be treated and additionally for the target lesion. A negative change from Baseline indicates improvement in overall IGA score.
Measured: Baseline, Week 4
Change From Baseline in Overall IGA Score at Week 4 [Using Last Observation Carried Forward (LOCF) Analysis]
The IGA allows for an assessment of overall disease severity at a given time point, and it consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. Missing overall IGA scores at Week 4 were imputed using LOCF method. A negative change from Baseline indicates improvement in overall IGA score.
Measured: Baseline, Week 4
Percentage of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An serious adverse event (SAE) was defined as any event which resulted in death, was life-threatening, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly/birth defect, or was another medically significant event.
Measured: From signing of informed consent through Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 20143 Feb 2015

First posted21 Feb 2014 (estimated)
Study start20 Jun 2014
Primary completion28 Jan 2015
Study completion3 Feb 2015

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.
Other trials for Atopic DermatitisStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.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: Double blind
Who is masked: Participant, Investigator
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02068352
Sponsor's protocol ID: 271-12-205
Other IDs: 2013-003899-12
Status last verified: Oct 2021
First submitted: 19 Feb 2014
Last updated: 23 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
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First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
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All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Multi-center, Randomized, Double-blind, Vehicle-controlled, Three-arm, Parallel Group Study to Assess the Safety, Tolerability, and Efficacy of Topical OPA-15406 Ointment, in Subjects With Mild/Moderate Atopic Dermatitis
ClinicalTrials.gov ID: NCT02068352
Acronym / sponsor ID: 271-12-205
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis, Eczema
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
Study start: 20 Jun 2014 (actual)
Primary completion: 28 Jan 2015 (actual)
Study completion: 3 Feb 2015 (actual)
First posted: 21 Feb 2014 (estimated)
Results: Posted 23 Nov 2021

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 investigate the effectiveness and safety of 2 concentrations of OPA-15406 compared to vehicle in participants with atopic dermatitis (AD).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
0.3% OPA-15406	Experimental	Drug: OPA-15406OPA-15406 0.3% ointment was applied topically twice daily (BID) to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
1% OPA-15406	Experimental	Drug: OPA-15406OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
Vehicle Ointment	Placebo comparator	Drug: Vehicle ointmentOPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.

Who may qualify

Ages: 10 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Participants 10-70 years of age
Diagnosis of AD
History of AD for at least 3 years
AD affecting greater than or equal to 5% and less than or equal to 40% of total body surface area (BSA) at Baseline
Investigator's Global Assessment of Disease Severity score of 2 (mild) or 3 (moderate) in the selected treatment area(s)

Key exclusion criteria (2 listed)

Contact or atopic dermatitis flare within 28 days of the Baseline (Day 1) visit.
Concurrent diseases/conditions and history of other diseases/conditions in the selected treatment area(s) that may have an impact on the study assessments.

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
OPA-15406OPA-15406 topical ointment	Drug	0.3% OPA-15406, 1% OPA-15406
Vehicle ointmentOPA-15406 1%-matching placebo topical ointment	Drug	Vehicle Ointment

Primary outcome

Percentage of Participants With Success in the Overall Investigator's Global Assessment of Disease Severity (IGA) Score at Week 4 [Using Non-responder Imputation or Last Observation Carried Forward (LOCF)]
Time frame: Week 4
The IGA evaluation was performed by a certified rater. The IGA score, used to assess the overall disease severity, consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. The IGA assessment was performed for the overall selected treatment area(s): overall percentage body surface area to be treated and additionally for the target lesion. Success was defined as a score of 0 or 1 with at least a 2-grade reduction from Baseline. Participants without IGA score at Week 4 were treated as non-responders. In the sensitivity analysis, missing IGA score at Week 4 was imputed using LOCF method first and the success was defined based on the imputed IGA score.

3 secondary outcomes

Change From Baseline in Overall IGA Score at Week 4 [Using Mixed Model Repeated Measures (MMRM) Analysis]
Time frame: Baseline, Week 4
Change From Baseline in Overall IGA Score at Week 4 [Using Last Observation Carried Forward (LOCF) Analysis]
Time frame: Baseline, Week 4
Percentage of Participants With Adverse Events (AEs)
Time frame: From signing of informed consent through Week 8

Results and safety

Results posted to the registry on 23 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0.3% OPA-15406	41	31
1% OPA-15406	43	35
Vehicle Ointment	37	28

Primary outcome: Percentage of Participants With Success in the Overall Investigator's Global Assessment of Disease Severity (IGA) Score at Week 4 [Using Non-responder Imputation or Last Observation Carried Forward (LOCF)]

Time frame: Week 4. Number. Unit: percentage of participants

Measure	0.3% OPA-15406 n = 41	1% OPA-15406 n = 43	Vehicle Ointment n = 37
Non-responders	14.63	20.93	2.70
LOCF	15.00	20.93	2.70

0.3% OPA-15406 vs Vehicle Ointment: Mean Difference: 11.93 (95% CI -0.08 to 23.95), p = 0.0690, Cochran-Mantel-Haenszel
1% OPA-15406 vs Vehicle Ointment: Mean Difference: 18.23 (95% CI 4.99 to 31.46), p = 0.0165, Cochran-Mantel-Haenszel
0.3% OPA-15406 vs Vehicle Ointment: Mean Difference: 12.30 (95% CI 0.06 to 24.53), p = 0.0617, Cochran-Mantel-Haenszel

Population analysed: Efficacy Sample included all participants who were randomized and received at least one dose of IMP. Number analyzed is the number of participants meeting responder criteria defined as an IGA score of 0 or 1 and at least 2-grade reduction from Baseline.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing the informed consent until the end of the Treatment Period (Up to Week 8). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.3% OPA-15406	2 of 41 (4.9%)	22 of 41 (53.7%)	0 of 41
1% OPA-15406	2 of 43 (4.7%)	13 of 43 (30.2%)	0 of 43
Vehicle Ointment	0 of 37 (0%)	16 of 37 (43.2%)	0 of 37

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Related trials for Atopic Dermatitis

Not yet recruitingPhase 1
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RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
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RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
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RecruitingPhase 3
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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.

30 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OPA-15406 in people with Atopic Dermatitis, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 30 sites in 3 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 5 inclusion and 2 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 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Australia, Poland. 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 23 Nov 2021). 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?

Percentage of Participants With Success in the Overall Investigator's Global Assessment of Disease Severity (IGA) Score at Week 4 [Using Non-responder Imputation or Last Observation Carried Forward (LOCF)] (time frame: Week 4). 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 NCT02068352.

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 23 Nov 2021.