A Study to Assess the Safety, Tolerability, PK and PD of AM1030-CREAM in Patients With Atopic Dermatitis

A Phase 1/2 study of Atopic Dermatitis, run by AnaMar AB at 2 sites in United Kingdom.

Completed

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

Trial summary

This is a study of safety, tolerability, pharmacokinetics and pharmacodynamics of AM1030-CREAM in patients with Atopic Dermatitis. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Atopic Dermatitis
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 2 sitesUnited Kingdom
Study dates: Nov 2014to Jun 2015
Phase: Phase 1/2
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and/or females of any ethnic origin between 18 and 65 years of age
Body mass index between 18.0 and 35.0 kg/m2
Subjects with AD as defined by the Hanifen and Rajka criteria and with mild to severe disease activity (IGA 2-4)
AD lesions amenable to cutaneous treatment located on the trunk and/or limbs

Who cannot join

Subjects with scars, moles, tattoos, sunburn or other blemishes in test areas
Systemic treatment with immunosuppressants, immunomodulators or corticosteroids within 2 weeks prior to dosing
Topical treatment with corticosteroids, antibiotics and/or immunomodulators within 4 days prior to dosing
Treatment with systemic antihistamines within 24 hours of the first dose administration
Treatment with SSRIs within 2 weeks of the first dose administration
Subjects who have received phototherapy within 4 weeks prior to dosing

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

Covance CRU
Leeds, LS2 9LH
CRLCRU Royal Liverpool University Hospital
Liverpool, L7 8XP

Other trials in United Kingdom

About this study

Official title: AM1030: A Phase I/II, Double-Blind, Placebo-Controlled, Single and Multiple Ascending (Topical) Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Patients (Male and Female) With Atopic Dermatitis

This is a study of safety, tolerability, pharmacokinetics and pharmacodynamics of AM1030-CREAM in patients with Atopic Dermatitis.

Conditions: Atopic Dermatitis
Being tested: AM1030-CREAM or 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.

AM1030-CREAM or placeboDrug

Study groups in NCT02379910
Study group	Role	What they receive
SAD 1	Experimental	AM1030-CREAM Receives: Drug: AM1030-CREAM or placebo
SAD 2	Experimental	AM1030-CREAM Receives: Drug: AM1030-CREAM or placebo
SAD 3	Experimental	AM1030-CREAM Receives: Drug: AM1030-CREAM or placebo
MAD 1	Experimental	AM1030-CREAM Receives: Drug: AM1030-CREAM or placebo
MAD 2	Experimental	AM1030-CREAM Receives: Drug: AM1030-CREAM or placebo

What is being measured

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

Adverse Events
Number of adverse events as a measure of Safety
Measured: Day 1-15
Local Tolerability: Change in Erythema (Likert scale 0-4)
Change in Erythema (Likert scale 0-4) as a measure of Local Tolerability
Measured: Day 1-15
Local Tolerability: Change in Oedema (Likert scale 0-3)
Change in Oedema (Likert scale 0-3) as a measure of Local Tolerability
Measured: Day 1-15
Local Tolerability: Change in Burning (Likert scale 0-3)
Change in Burning (Likert scale 0-3) as a measure of Local Tolerability
Measured: Day 1-15
Local Tolerability: Change in Prutitus (VAS)
Change in Prutitus (VAS) as a measure of Local Tolerability
Measured: Day 1-15
Vital Signs
Change in blood pressure as a measure of Safety
Measured: Day 1-15
Vital Signs
Change in pulse rate as a measure of Safety
Measured: Day 1-15
Vital Signs
Change in body temperature as a measure of Safety
Measured: Day 1-15
ECG
Change in ECG as a measure of Safety
Measured: Day 1-15
Physical Examination
Any abnormal observations from Physical Examination as a measure of Safety
Measured: Day 1-15

Secondary outcomes (4)

Pharmacokinetics: Cmax, AUC, tmax, t1/2, Vss/F, CL/F
Pharmacokinetics as measured by Cmax, AUC, tmax, t1/2, Vss/F, CL/F
Measured: Profil Day 1-15
Pruritus on a Visual Analog Scale
Pruritus (Visual Analog Scale 10 cm) as a measure of Efficacy
Measured: Day 1-15
Erythema on a Likert scale
Erythema (Likert Scale 0-4) as a measure of Efficacy
Measured: Day 1-15
Modified Eczema Area and Severity Index (mEASI)
mEASI (Composite score 0-64.8) as a measure of Efficay
Measured: Day 1-15

Timeline

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

Nov 2014Jun 2015

First posted5 Mar 2015 (estimated)
Study startNov 2014
Primary completionJun 2015
Study completionJun 2015

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.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02379910
Sponsor's protocol ID: 1030-260-01
Other IDs: 2014-003684-38, 2014
Status last verified: Dec 2015
First submitted: 19 Feb 2015
Last updated: 11 Dec 2015
Results posted: No
Data monitoring committee: No

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

RecruitingPhase 3
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
Atopic Dermatitis
RecruitingPhase 2
A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Atopic Dermatitis, Eczema, Atopic
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
Active, not recruiting
Xerosis and Use of Topical Moisturizer
Xerosis Due to Atopic Dermatitis
Not yet recruiting
Cosmetic Efficacy Evaluation of Hydraporin AI Cream in Individuals With Atopic Dermatitis and Psoriasis
Atopic Dermatitis, Psoriasis

All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AM1030: A Phase I/II, Double-Blind, Placebo-Controlled, Single and Multiple Ascending (Topical) Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Patients (Male and Female) With Atopic Dermatitis
ClinicalTrials.gov ID: NCT02379910
Acronym / sponsor ID: 1030-260-01
Conditions: Atopic Dermatitis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: AnaMar ABIndustry (pharma, biotech, devices)
Collaborators: Covance
Study start: Nov 2014
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 5 Mar 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.

This is a study of safety, tolerability, pharmacokinetics and pharmacodynamics of AM1030-CREAM in patients with Atopic Dermatitis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
SAD 1	Experimental	Drug: AM1030-CREAM or placeboAM1030-CREAM
SAD 2	Experimental	Drug: AM1030-CREAM or placeboAM1030-CREAM
SAD 3	Experimental	Drug: AM1030-CREAM or placeboAM1030-CREAM
MAD 1	Experimental	Drug: AM1030-CREAM or placeboAM1030-CREAM
MAD 2	Experimental	Drug: AM1030-CREAM or placeboAM1030-CREAM

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Males and/or females of any ethnic origin between 18 and 65 years of age
Body mass index between 18.0 and 35.0 kg/m2
Subjects with AD as defined by the Hanifen and Rajka criteria and with mild to severe disease activity (IGA 2-4)
AD lesions amenable to cutaneous treatment located on the trunk and/or limbs

Key exclusion criteria (6 listed)

Subjects with scars, moles, tattoos, sunburn or other blemishes in test areas
Systemic treatment with immunosuppressants, immunomodulators or corticosteroids within 2 weeks prior to dosing
Topical treatment with corticosteroids, antibiotics and/or immunomodulators within 4 days prior to dosing
Treatment with systemic antihistamines within 24 hours of the first dose administration
Treatment with SSRIs within 2 weeks of the first dose administration

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
AM1030-CREAM or placebo	Drug	MAD 1, MAD 2, SAD 1, SAD 2, SAD 3

Primary outcome

Adverse Events
Time frame: Day 1-15
Number of adverse events as a measure of Safety
Local Tolerability: Change in Erythema (Likert scale 0-4)
Time frame: Day 1-15
Change in Erythema (Likert scale 0-4) as a measure of Local Tolerability
Local Tolerability: Change in Oedema (Likert scale 0-3)
Time frame: Day 1-15
Change in Oedema (Likert scale 0-3) as a measure of Local Tolerability
Local Tolerability: Change in Burning (Likert scale 0-3)
Time frame: Day 1-15
Change in Burning (Likert scale 0-3) as a measure of Local Tolerability
Local Tolerability: Change in Prutitus (VAS)
Time frame: Day 1-15
Change in Prutitus (VAS) as a measure of Local Tolerability
Vital Signs
Time frame: Day 1-15
Change in blood pressure as a measure of Safety
Vital Signs
Time frame: Day 1-15
Change in pulse rate as a measure of Safety
Vital Signs
Time frame: Day 1-15
Change in body temperature as a measure of Safety
ECG
Time frame: Day 1-15
Change in ECG as a measure of Safety
Physical Examination
Time frame: Day 1-15
Any abnormal observations from Physical Examination as a measure of Safety

4 secondary outcomes

Pharmacokinetics: Cmax, AUC, tmax, t1/2, Vss/F, CL/F
Time frame: Profil Day 1-15
Pruritus on a Visual Analog Scale
Time frame: Day 1-15
Erythema on a Likert scale
Time frame: Day 1-15
Modified Eczema Area and Severity Index (mEASI)
Time frame: Day 1-15

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 Dec 2015.

Related trials for Atopic Dermatitis

RecruitingPhase 3
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
Atopic Dermatitis
RecruitingPhase 2
A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Atopic Dermatitis, Eczema, Atopic
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
Active, not recruiting
Xerosis and Use of Topical Moisturizer
Xerosis Due to Atopic Dermatitis
Not yet recruiting
Cosmetic Efficacy Evaluation of Hydraporin AI Cream in Individuals With Atopic Dermatitis and Psoriasis
Atopic Dermatitis, Psoriasis

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.

Jim Bush principal investigator

Covance CRU

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study of Atopic Dermatitis, run by AnaMar AB at 2 sites in United Kingdom.

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 6 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 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 2 sites in United Kingdom. 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 combined 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.

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?

Adverse Events (time frame: Day 1-15). The study lists 10 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 NCT02379910.

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 Dec 2015.