Atopic DermatitisPhase 1NCT03556592
Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4
A Phase 1 study testing Tralokinumab, Caffeine and Warfarin in people with Atopic Dermatitis, run by LEO Pharma at 12 sites in 3 countries.
Trial summary
The purpose of this trial is to investigate if tralokinumab changes the metabolism of selected CYP substrates in adults with moderate-to-severe AD after: 14 weeks of treatment with tralokinumab a single dose of tralokinumab Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Tralokinumab, Caffeine and Warfarin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 13 Aug 2018to 20 Jun 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and above.
- Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.
- History of AD for ≥1 year.
- Subjects who have a recent history of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable.
- AD involvement of ≥10% body surface area at screening and baseline.
- Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.
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- Willingness to abstain from consumption of any 1 or more of the following items in the periods specified:
- ±7 days within each cocktail dosing visit: foods/beverages that affect the CYP system:
- Grapefruit or grapefruit juice, Seville oranges or orange juice, starfruit, pomegranate and cranberry juices, red wine, red grape extract.
- Cruciferous vegetables (for example broccoli).
- Chargrilled meat.
- ±48 hours within each cocktail dosing visit: caffeinated beverages and foods/drugs that contain caffeine.
Who cannot join
- Administration, within 14 days or 5 half-lives (whichever is longer) prior to Day -7, of any medication that is a known inducer or inhibitor of 1 or more of the following CYP enzymes: CYP3A, CYP2C19, CYP2C9, CYD2D6, and CYP1A2.
- Subjects who are poor metabolisers of CYP2C9, CYP2C19, or CYP2D6, based on genotyping.
- Any contraindication to 1 or more of the following drugs, according to the applicable labelling: caffeine, warfarin, omeprazole, metoprolol, or midazolam.
- Consumption of any 1 or more of the following items in the periods specified:
- ±7 days within each cocktail dosing visit: foods/beverages that affect the CYP system:
- Grapefruit or grapefruit juice, Seville oranges or orange juice, starfruit, pomegranate and cranberry juices, red wine, red grape extract.
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- Cruciferous vegetables (for example broccoli).
- Chargrilled meat.
- ±48 hours within each cocktail dosing visit: caffeinated beverages and foods/drugs that contain caffeine.
- Nausea or diarrhoea 1 week prior to Day -7.
- Active dermatologic conditions that may confound the diagnosis of AD.
- Use of tanning beds or phototherapy within 5 weeks prior to Day -7.
- Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 3 weeks prior to Day -7.
- Treatment with topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase 4 inhibitors within 1 week prior to Day -7.
- Receipt of any marketed biological therapy or investigational biologic agent (including immunoglobulin, anti-IgE, or dupilumab):
- Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to Day -7, or until lymphocyte count returns to normal, whichever is longer.
- Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to Day -7.
- Active skin infection within 1 week prior to Day -7.
- Clinically significant infection within 4 weeks prior to Day -7.
- A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
- Tuberculosis requiring treatment within 12 months prior to screening.
- Known primary immunodeficiency disorder.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States9 sites
LEO Pharma Investigational Site
Doral, Florida, 33122
LEO Pharma Investigational Site
Little Rock, Arkansas, 72212
LEO Pharma Investigational Site
Miami, Florida, 33015
LEO Pharma Investigational Site
Miami, Florida, 33144
LEO Pharma Investigational Site
Norfolk, Virginia, 23502
LEO Pharma Investigational Site
Quincy, Massachusetts, 02169
LEO Pharma Investigational Site
Rogers, Arkansas, 72758
LEO Pharma Investigational Site
San Diego, California, 92119
LEO Pharma Investigational Site
Spartanburg, South Carolina, 29303
France2 sites
LEO Pharma Investigational Site
Nice, 06202
LEO Pharma Investigational Site
Paris, 75010
About this study
Official title: An Open-label, Multi Centre Drug-drug Interaction Trial to Investigate the Effects of Tralokinumab on the Pharmacokinetics of Selected Cytochrome P450 Substrates in Adult Subjects With Moderate-to-severe Atopic Dermatitis
The purpose of this trial is to investigate if tralokinumab changes the metabolism of selected CYP substrates in adults with moderate-to-severe AD after:
- 14 weeks of treatment with tralokinumab
- a single dose of tralokinumab
- Conditions
- Atopic Dermatitis
- Being tested
- Tralokinumab, Caffeine, Warfarin, Omeprazole, Metoprolol
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TralokinumabDrug
Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.
CaffeineDrug
1x 100 mg tablet
WarfarinDrug
2x 5 mg tablets
OmeprazoleDrug
1x 20 mg capsule
MetoprololDrug
1x 100 mg tablet
Midazolam HydrochlorideDrug
1 mL of 2 mg/mL oral solution/syrup
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | Tralokinumab - investigational medicinal product:
Week 0: subcutaneous (SC) injection of tralokinumab loading dose.
Week 2 to Week 14: SC injection of tralokinumab maintenance dose.
CYP substrates - non-investigational medicinal products:
Week -1, Week 1, and Week 15: oral administration of caffeine 100 mg, warfarin sodium 5 mg x2, omeprazole 20 mg, metoprolol tartrate 100 mg, and midazolam hydrochloride 2 mg. Receives: Drug: Tralokinumab; Drug: Caffeine; Drug: Warfarin; Drug: Omeprazole; Drug: Metoprolol; Drug: Midazolam Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of the AUC-last at Week 15 (after multiple doses of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates
AUC-last = area under the plasma concentration curve from time 0 to the last quantifiable observation
Measured: Day -7 and Week 15
Ratio of the Cmax at Week 15 (after multiple doses of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates
Cmax = maximum observed plasma concentration
Measured: Day -7 and Week 15
Secondary outcomes (5)
Ratio of the AUC-last on Day 8 (after a single dose of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates
AUC-last = area under the plasma concentration curve from time 0 to the last quantifiable observation
Measured: Day -7 and Day 8
Ratio of the Cmax on Day 8 (after a single dose of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates
Cmax = maximum observed plasma concentration
Measured: Day -7 and Day 8
Ratio of the AUC-inf on Day 8 (after a single dose of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates
AUC-inf = area under the plasma concentration curve from time 0 to infinity
Measured: Day -7 and Day 8
Number of adverse events
Measured: From Day 1 up to Week 30
Presence of anti-drug antibodies (yes/no)
Measured: From Day 1 up to Week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start13 Aug 2018
- Primary completion16 Mar 2020
- Study completion20 Jun 2020
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556592
- Sponsor's protocol ID
- LP0162-1342
- Other IDs
- 2018-000534-35, 2018
- Status last verified
- Oct 2020
- First submitted
- 30 May 2018
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi Centre Drug-drug Interaction Trial to Investigate the Effects of Tralokinumab on the Pharmacokinetics of Selected Cytochrome P450 Substrates in Adult Subjects With Moderate-to-severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03556592
- Acronym / sponsor ID
- LP0162-1342
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 14 Jun 2018 (actual)
- 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 trial is to investigate if tralokinumab changes the metabolism of selected CYP substrates in adults with moderate-to-severe AD after:
- 14 weeks of treatment with tralokinumab
- a single dose of tralokinumab
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Drug: Tralokinumab, Drug: Caffeine, Drug: Warfarin, Drug: Omeprazole, Drug: Metoprolol, Drug: Midazolam HydrochlorideTralokinumab - investigational medicinal product: Week 0: subcutaneous (SC) injection of tralokinumab loading dose. Week 2 to Week 14: SC injection of tralokinumab maintenance dose. CYP substrates - non-investigational medicinal products: Week -1, Week 1, and Week 15: oral administration of caffeine 100 mg, warfarin sodium 5 mg x2, omeprazole 20 mg, metoprolol tartrate 100 mg, and midazolam hydrochloride 2 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 and above.
- Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.
- History of AD for ≥1 year.
- Subjects who have a recent history of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable.
- AD involvement of ≥10% body surface area at screening and baseline.
Key exclusion criteria (22 listed)
- Administration, within 14 days or 5 half-lives (whichever is longer) prior to Day -7, of any medication that is a known inducer or inhibitor of 1 or more of the following CYP enzymes: CYP3A, CYP2C19, CYP2C9, CYD2D6, and CYP1A2.
- Subjects who are poor metabolisers of CYP2C9, CYP2C19, or CYP2D6, based on genotyping.
- Any contraindication to 1 or more of the following drugs, according to the applicable labelling: caffeine, warfarin, omeprazole, metoprolol, or midazolam.
- Consumption of any 1 or more of the following items in the periods specified:
- Nausea or diarrhoea 1 week prior to Day -7.
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 |
|---|---|---|
| TralokinumabHuman recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection. | Drug | All subjects |
| Caffeine1x 100 mg tablet | Drug | All subjects |
| Warfarin2x 5 mg tablets | Drug | All subjects |
| Omeprazole1x 20 mg capsule | Drug | All subjects |
| Metoprolol1x 100 mg tablet | Drug | All subjects |
| Midazolam Hydrochloride1 mL of 2 mg/mL oral solution/syrup | Drug | All subjects |
Primary outcome
Ratio of the AUC-last at Week 15 (after multiple doses of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates
Time frame: Day -7 and Week 15
AUC-last = area under the plasma concentration curve from time 0 to the last quantifiable observation
Ratio of the Cmax at Week 15 (after multiple doses of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates
Time frame: Day -7 and Week 15
Cmax = maximum observed plasma concentration
5 secondary outcomes
Ratio of the AUC-last on Day 8 (after a single dose of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates
Time frame: Day -7 and Day 8
Ratio of the Cmax on Day 8 (after a single dose of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates
Time frame: Day -7 and Day 8
Ratio of the AUC-inf on Day 8 (after a single dose of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates
Time frame: Day -7 and Day 8
Number of adverse events
Time frame: From Day 1 up to Week 30
Presence of anti-drug antibodies (yes/no)
Time frame: From Day 1 up to Week 30
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 24 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Medical expert study director
LEO Pharma
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tralokinumab, Caffeine and Warfarin in people with Atopic Dermatitis, run by LEO Pharma at 12 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 12 inclusion and 22 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 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, France, Netherlands. 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 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?
Ratio of the AUC-last at Week 15 (after multiple doses of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates (time frame: Day -7 and Week 15). The study lists 2 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 24 Feb 2025.