Dermatitis, AtopicPhase 1NCT02576093

Safety, Tolerability, Pharmacokinetics and Efficacy of WOL071-007 in Atopic Dermatitis Patients

A Phase 1 study testing 0.1% WOL071-007, 0.3% WOL071-007 and 1.0% WOL071-007 in people with Dermatitis, Atopic, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Germany.

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

Purpose of the study is the local tolerability and systemic safety of a novel k-opioid receptor agonist proven to inhibit inflammation and pruritus in preclinical model of dermatitis. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Dermatitis, Atopic
What is being tested?: 0.1% WOL071-007, 0.3% WOL071-007 and 1.0% WOL071-007
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 58 participants
Where: 1 siteGermany
Study dates: Mar 2014to Jul 2015
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent, including acceptance of biopsies.
Male / female.
Age between 18 and 75 years.
Body weight between 60 and 130 kg for males and between50 and 110 kg for females. In addition the Body Mass Index (BMI) range limit of 19 - 32 kg/m² (both inclusive) is applicable.
Lesional skin (at least 50 cm²) anywhere on the body (non-hairy skin) (SAD part only).
Score of ≥40mm on all screening pruritus visual analogue scale (vas) assessments (average and worst over the last 24 hours and current itch) (MAD part only).
Stable disease for ≥7 days prior to screening (MAD part only).
Eczema on the right and left crook of the arms, or in the hollow of the knees (MAD part only).

Who cannot join

Absence of written informed consent upon enrolment.
Atopic dermatitis only affecting the head or scalp. Unstable or actively infected atopic dermatitis.
Patients with severe atopic dermatitis (IGADA score >2 or local SCORAD >12).
Concomitant dermatologic or medical condition(s) assessed by the investigator which may interfere with the investigator's ability to evaluate the patient's response to the study drug.
Patients who have received monoclonal antibody therapy for their atopic dermatitis in the 4 months prior to the start of study treatment.
Patients who have used systemic immunosuppressive drugs, corticosteroids or received puva therapy in the 4 weeks prior to starting study treatment, or are scheduled to start these treatments during the study period.

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Patients who have used topical immunomodulators (such as pimecrolimus, tacrolimus) within 1 week of starting study treatment or are scheduled to start these treatments during the study period.
Patients who have used topical corticosteroids from who group II, III or IV, or other treatments for atopic dermatitis, including wet wraps, within 1 week prior to starting study treatment or are likely to require treatment with these medications during the study period of the SAD and MAD parts and from day 7 until day 14 of the MAD part.
Patients who are unable to abstain from using emollients in the target imp (verum and placebo) assessment areas from day -3 until day 4 during the SAD part and from day -3 until day 14 during the MAD part.
Patients who are using any concomitant medication(s), e.g. antihistamines, psychotropic drugs, immunosuppressive drugs, and immunologic drugs that, in the investigators' opinion, could affect the patient's atopic dermatitis or pruritus. Patients using such medications may be included, at the investigators discretion, if they have been stable on treatment for at least 1 month prior to the start of study treatment and no changes to these medications are planned during the study period.
Patients undergoing ultraviolet A or B (UVA or UVB) therapy in the 2 weeks prior to starting study treatment or during the study period.
Planned exposure of affected areas to excessive sunlight.
Patients with any of the liver function tests (aspartate aminotransferase [ast], alanine aminotransferase [alt], alkaline phosphatase [alp], gamma-glutamyl-transferase [ggt]) >2.0 x upper limit of normal, or with any clinically significant abnormal safety laboratory tests.
Patients who are receiving any investigational drug or who have taken part in a clinical study with an investigational drug within three months prior to the start of study treatment.
History of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study.
Patients who are HIV-seropositive.
History or presence of alcohol or substance abuse.
Regular smokers (more than 20 cigarettes or 5 cigars per day).
Clinically relevant physical abnormalities, medical conditions or clinical laboratory test results e.g. gastrointestinal, renal, hepatic, pulmonary, cardiac, hematological, endocrinological, neurological, or psychiatric conditions.
Clinically relevant symptoms (other than those in the inclusion criteria) within two weeks prior to the start of the study.
History of blood loss exceeding 450 ml (including blood donations) within 1 month before the study.
History of clinically relevant jaundice (exceptions: completely healed hepatitis a, new-born infant's jaundice).
Clinically relevant abnormalities in the 12-lead electrocardiogram (ECG) with marked baseline prolongation (QT/QTC, QTC interval > 500 msec) [QTC=corrected QT interval].
Relevant systemic disease history, either past with sequel, or present, on physical examination.
any condition (surgical or medical) which may affect absorption, distribution, metabolism and/or excretion of the drug.
Known history of either an acute or chronic allergy requiring medical therapy.
Intake of any medical treatment, e.g. antihistamines, including over the counter products, within one week before start of treatment or during the study (with the exception of dietary supplements such as iodine or fluoride in physiological doses), which could interfere with study medication in the opinion of the investigator.
Not willing to give consent for transmission of personal "pseudonymity" data.
Not willing and able to use a contraceptive method. Reliable methods for women are double barrier methods including hormonal contraceptives, surgical intervention (e.g. tubal ligation), intrauterine device (IUD) or sexual abstinence, e.g. condoms used plus spermicide or oral contraceptives. Women must use reliable methods from 6 weeks before the first administration of test product until 3 weeks after the last administration of the study medication. Men must use reliable methods from 3 weeks before the first administration of test product until 3 months after the last administration of the study medication. Reliable methods for men are condoms and sexual abstinence.
For females: pregnancy or lactation.
Patients who are unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study.
Regular consumption of large amounts of caffeine-containing beverages which, in the opinion of the investigator, could interfere with study procedures.
Subject is a vulnerable subject (e.g. kept in detention).

Trial locations and contacts

1 site in 1 country.

Germany1 site

PAREXEL International GmbH Early Phase
Berlin, State of Berlin, 14050

Other trials in Germany

About this study

Official title: First-in-human, Single Center, Combined SAD/MAD, Double-blind, Placebo-controlled, Half-side Comparison Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of 0.1%, 0.3% and 1% WOL071-007-containing Formulations in Atopic Dermatitis Patients

Purpose of the study is the local tolerability and systemic safety of a novel k-opioid receptor agonist proven to inhibit inflammation and pruritus in preclinical model of dermatitis.

Three concentrations of WOL071-007 and placebo will be applied to patients with AD in a first-in-human, single-center, combined single/multiple ascending dose (SAD/MAD), double-blind, placebo-controlled, half-side comparison (MAD part only) study. The IMP will be applied occlusively to lesional or non-lesional skin. In the SAD part 24 subjects will receive the IMP for 2 days. In the MAD part, 30 hospitalized subjects will receive the IMP for 6 days. Study objectives are the safety and tolerability as well as (MAD part only) the pharmacokinetics and efficacy of WOL071-007.

Read the detailed description

Three concentrations of the Investigational Medicinal Product (IMP) WOL071-007 (= active IMP) or placebo will be applied to patients with a clinical diagnosis of atopic dermatitis at screening with an Investigator's Global Dermatitis Assessment (IGADA) score of 1 or 2 (mild to moderate) and/or a local SCORing Atopic Dermatitis (SCORAD) ≤12.

Each dose level cohort will begin with 2 sentinel patients: 1 patient randomized to receive active IMP and the other patient randomized to receive placebo only. From the remaining patients 1 patient will be randomized to receive placebo.

In the Single Ascending Dose (SAD) part of the study the active IMP or placebo will be applied to a defined surface area of ≤ 100 cm² of non-lesional skin (Day 1) or lesional skin (Day 2) for about 22 hours and the patients will remain in the study center for at least 6 hours after dosing.

In the Multiple Ascending Dose (MAD) part placebo or test product + placebo (half-side comparison) will be administered up to 24 hours to achieve a defined surface area of approximately 2000 cm² in total (10% Body Surface Area) for each dose level cohort. A Data Safety Monitoring Board will review the data and recommend continuation following each dose level cohort.

Primary criteria for evaluation are safety assessments, e.g. by Adverse Event (AE) recording, and assessments of the local tolerability (by scoring of local symptoms) as well as of the systemic tolerability (e.g. by blood tests and neurological examination) of WOL071-007. In the MAD part additionally pharmacokinetics will be measured and as secondary parameter local efficacy.

Conditions: Dermatitis, Atopic
Being tested: 0.1% WOL071-007, 0.3% WOL071-007, 1.0% WOL071-007, Placebo of WOL071-007
Medical subject headings: Dermatitis, Atopic

What participants receive

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

0.1% WOL071-007Drug
Application of approximately 2 mg cream/cm² skin to a defined surface area. SAD part: Single application to ≤ 100 cm² of non-lesional or lesional skin; MAD part: Multiple application (6 Days) to 2000 cm² of lesional and non-lesional skin.
0.3% WOL071-007Drug
Application of approximately 2 mg cream/cm² skin to a defined surface area. SAD part: Single application to ≤ 100 cm² of non-lesional or lesional skin; MAD part: Multiple application (6 Days) to 2000 cm² of lesional and non-lesional skin.
1.0% WOL071-007Drug
Application of approximately 2 mg cream/cm² skin to a defined surface area. SAD part: Single application to ≤ 100 cm² of non-lesional or lesional skin; MAD part: Multiple application (6 Days) to 2000 cm² of lesional and non-lesional skin.
Placebo of WOL071-007Drug
Application of approximately 2 mg cream/cm² skin to a defined surface area. SAD part: Single application to ≤ 100 cm² of non-lesional or lesional skin; MAD part: Multiple application (6 Days) to 2000 cm² of lesional and non-lesional skin.

Study groups in NCT02576093
Study group	Role	What they receive
0.1% WOL071-007	Experimental	Formulation containing 0.1% WOL071-007 for topical application Receives: Drug: 0.1% WOL071-007
0.3% WOL071-007	Experimental	Formulation containing 0.3% WOL071-007 for topical application Receives: Drug: 0.3% WOL071-007
1.0% WOL071-007	Experimental	Formulation containing 1.0% WOL071-007 for topical application Receives: Drug: 1.0% WOL071-007
WOL071-007 Placebo	Placebo comparator	Formulation containing Placebo of WOL071-007 for topical application Receives: Drug: Placebo of WOL071-007

What is being measured

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

Safety of WOL071-007 by recording adverse events (AEs) and other safety parameters over the Study Period
Number of participants with AEs related to treatment and/or abnormal vital signs (blood pressure, pulse and temperature), monitored on each study day.
Measured: SAD part: 2 days; MAD part: 7 days
Local tolerability over the Study Period
Number of participants with a change in at least one item of local tolerability scores (erythema, edema, vesiculation, oozing, scaling, cracking or crazing, scabbing, papules, reaction spreading outside area of application, glazing, burning or stinging), monitored on each study day.
Measured: SAD part: 2 days; MAD part: 7 days
Systemic Tolerability over the Study Period
Number of participants with results from neurological examination other than normal (covering possible central and peripheral neurological disorders) and/or with abnormal safety laboratory values (standard hematology, blood chemistry), monitored on each study day.
Measured: SAD part: 2 days; MAD part: 7 days

Secondary outcomes (5)

Maximum Plasma Concentration (Cmax) over the Treatment Period (MAD part only)
Determined from 24h blood sampling (pre-dose and after 1h, 2h, 4h, 6h, 8h and 24h) on days 1, 3, 4, 5 and 6; Plasma concentration-time data will be summarized by treatment with descriptive statistics and mean and individual plasma concentration-time curves will be plotted.
Measured: 6 days
Change in Local Pruritus Intensity over the Study Period (MAD part only)
To be assessed by the patient (self-reporting) using the visual analogue scale, monitored on each study day.
Measured: 7 days
Change in Atopic Dermatitis Severity assessed by Eczema Area and Severity Index (EASI) over the Study Period (MAD part only)
To be assessed at the treated skin area and by the change from baseline.
Measured: 7 days
Change in Atopic Dermatitis Severity assessed by IGADA scores over the Study Period (MAD part only)
To be assessed at the treated skin area and by the change from baseline.
Measured: 7 days
Change in Atopic Dermatitis Severity assessed by local SCORAD over the Study Period (MAD part only)
To be assessed at the treated skin area and by the change from baseline, monitored on each study day.
Measured: 7 days

Timeline

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

Mar 2014Jul 2015

First posted15 Oct 2015 (estimated)
Study startMar 2014
Primary completionJul 2015
Study completionJul 2015

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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02576093
Sponsor's protocol ID: KOR1-14/2013
Status last verified: Oct 2015
First submitted: 4 Sep 2015
Last updated: 16 Oct 2015
Results posted: No
Data monitoring committee: Yes

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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All Dermatitis, Atopic trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: First-in-human, Single Center, Combined SAD/MAD, Double-blind, Placebo-controlled, Half-side Comparison Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of 0.1%, 0.3% and 1% WOL071-007-containing Formulations in Atopic Dermatitis Patients
ClinicalTrials.gov ID: NCT02576093
Acronym / sponsor ID: KOR1-14/2013
Conditions: Dermatitis, Atopic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Dr. August Wolff GmbH & Co. KG ArzneimittelIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: Mar 2014
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 15 Oct 2015 (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.

Purpose of the study is the local tolerability and systemic safety of a novel k-opioid receptor agonist proven to inhibit inflammation and pruritus in preclinical model of dermatitis.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
0.1% WOL071-007	Experimental	Drug: 0.1% WOL071-007Formulation containing 0.1% WOL071-007 for topical application
0.3% WOL071-007	Experimental	Drug: 0.3% WOL071-007Formulation containing 0.3% WOL071-007 for topical application
1.0% WOL071-007	Experimental	Drug: 1.0% WOL071-007Formulation containing 1.0% WOL071-007 for topical application
WOL071-007 Placebo	Placebo comparator	Drug: Placebo of WOL071-007Formulation containing Placebo of WOL071-007 for topical application

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Written informed consent, including acceptance of biopsies.
Male / female.
Age between 18 and 75 years.
Body weight between 60 and 130 kg for males and between50 and 110 kg for females. In addition the Body Mass Index (BMI) range limit of 19 - 32 kg/m² (both inclusive) is applicable.
Lesional skin (at least 50 cm²) anywhere on the body (non-hairy skin) (SAD part only).

Key exclusion criteria (33 listed)

Absence of written informed consent upon enrolment.
Atopic dermatitis only affecting the head or scalp. Unstable or actively infected atopic dermatitis.
Patients with severe atopic dermatitis (IGADA score >2 or local SCORAD >12).
Concomitant dermatologic or medical condition(s) assessed by the investigator which may interfere with the investigator's ability to evaluate the patient's response to the study drug.
Patients who have received monoclonal antibody therapy for their atopic dermatitis in the 4 months prior to the start of study treatment.

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
0.1% WOL071-007Application of approximately 2 mg cream/cm² skin to a defined surface area. SAD part: Single application to ≤ 100 cm² of non-lesional or lesional skin; MAD part: Multiple application (6 Days) to 2000 cm² of lesional and non-lesional skin.	Drug	0.1% WOL071-007
0.3% WOL071-007Application of approximately 2 mg cream/cm² skin to a defined surface area. SAD part: Single application to ≤ 100 cm² of non-lesional or lesional skin; MAD part: Multiple application (6 Days) to 2000 cm² of lesional and non-lesional skin.	Drug	0.3% WOL071-007
1.0% WOL071-007Application of approximately 2 mg cream/cm² skin to a defined surface area. SAD part: Single application to ≤ 100 cm² of non-lesional or lesional skin; MAD part: Multiple application (6 Days) to 2000 cm² of lesional and non-lesional skin.	Drug	1.0% WOL071-007
Placebo of WOL071-007Application of approximately 2 mg cream/cm² skin to a defined surface area. SAD part: Single application to ≤ 100 cm² of non-lesional or lesional skin; MAD part: Multiple application (6 Days) to 2000 cm² of lesional and non-lesional skin.	Drug	WOL071-007 Placebo

Primary outcome

Safety of WOL071-007 by recording adverse events (AEs) and other safety parameters over the Study Period
Time frame: SAD part: 2 days; MAD part: 7 days
Number of participants with AEs related to treatment and/or abnormal vital signs (blood pressure, pulse and temperature), monitored on each study day.
Local tolerability over the Study Period
Time frame: SAD part: 2 days; MAD part: 7 days
Number of participants with a change in at least one item of local tolerability scores (erythema, edema, vesiculation, oozing, scaling, cracking or crazing, scabbing, papules, reaction spreading outside area of application, glazing, burning or stinging), monitored on each study day.
Systemic Tolerability over the Study Period
Time frame: SAD part: 2 days; MAD part: 7 days
Number of participants with results from neurological examination other than normal (covering possible central and peripheral neurological disorders) and/or with abnormal safety laboratory values (standard hematology, blood chemistry), monitored on each study day.

5 secondary outcomes

Maximum Plasma Concentration (Cmax) over the Treatment Period (MAD part only)
Time frame: 6 days
Change in Local Pruritus Intensity over the Study Period (MAD part only)
Time frame: 7 days
Change in Atopic Dermatitis Severity assessed by Eczema Area and Severity Index (EASI) over the Study Period (MAD part only)
Time frame: 7 days
Change in Atopic Dermatitis Severity assessed by IGADA scores over the Study Period (MAD part only)
Time frame: 7 days
Change in Atopic Dermatitis Severity assessed by local SCORAD over the Study Period (MAD part only)
Time frame: 7 days

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 16 Oct 2015.

Related trials for Dermatitis, Atopic

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
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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.

Christoph Abels, MD study director

Dr. August Wolff GmbH & Co. KG Arzneimittel

Georg Golor, MD principal investigator

Parexel GmbH

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 0.1% WOL071-007, 0.3% WOL071-007 and 1.0% WOL071-007 in people with Dermatitis, Atopic, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Germany.

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 8 inclusion and 33 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 16 Oct 2015. 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 Germany. 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 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?

Safety of WOL071-007 by recording adverse events (AEs) and other safety parameters over the Study Period (time frame: SAD part: 2 days; MAD part: 7 days). The study lists 3 primary outcomes in all. 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 NCT02576093.

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 16 Oct 2015.