Dermatitis AtopicPhase 1NCT06686628
An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates
A Phase 1 study testing Amlitelimab, Midazolam and Caffeine in people with Dermatitis Atopic, run by Sanofi at 1 site in Germany.
Trial summary
This is an open-label, single group, 2-period, Phase 1, single-sequence study. The study duration will be up to 342 days. The treatment period will be up to Week 29, where Week 29 is defined as End of Treatment (last amlitelimab administration at Week 25). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dermatitis Atopic
- What is being tested?
- Amlitelimab, Midazolam and Caffeine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- 20 Nov 2024to 2 Apr 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Male or female participant aged 18 to 65 years (inclusive), at the time of the informed consent is signed.
- Participants must have AD as defined by the American Academy of Dermatology Consensus Criteria (2014) for 1 year or longer before signing of informed consent.
- The EASI score ≥16 at Screening and Check-in (Day -1).
- vIGA-AD score ≥3 (on the 0 to 4 vIGA-AD scale) at Screening and Check-in (Day -1).
- AD involvement of ≥10% body surface area at Screening and Check-in (Day -1).
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- Participants must have documented history within 6 months prior to Screening and Check-in (Day -1), of either inadequate response (including inadequate efficacy or medical inadvisability) of topical treatments.
- Body weight within 40 to 150 kg at Screening and Day 1 and body mass index (BMI) <40 kg/m2 (inclusive).
- Capable of giving signed informed consent.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Known history of significant immunosuppression or suspected current significant immunosuppression, including history of invasive opportunistic, or helminthic infections.
- Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and cured for more than 5 years prior to baseline).
- Any concomitant illness that would, in the Investigator's opinion, inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure, and pulmonary disease.
- Any medical condition which, in the Investigator's opinion may present an unreasonable risk to the study participants as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments.
- Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline (1 week in the event of superficial skin infections) and any infection which as per Investigator's opinion precludes the participant's participation in the study or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals at Screening or Check--in (Day -1).
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- History or presence of substance abuse (including alcohol, nicotine) prior to Check-in (Day 1/V2) or regular alcohol consumption (>14 units per week for males and >7 units per week for females).
- In the Investigator's opinion, medical conditions related to prior AD medications that have not healed/fully recovered for more than 2 weeks before the Screening visit, including, but not limited to, conjunctivitis, keratitis, eosinophilic conditions, arthralgia, herpes zoster, thrombosis.
- Use of tobacco- or nicotine-containing products within 6 months prior to Check-in (Day -1).
- Poor metabolizers for CYP2C9, CYP2C19, or CYP2D6 based on genotyping.
- Treatment with a live (attenuated) vaccine within 12 weeks prior to baseline; failure to complete non-live immunization required by local regulation (eg, vaccination for COVID-19) at least 14 days prior to baseline.
- Any contraindication to one or more of the following CYP cocktail study interventions, according to the applicable labeling:
- Caffeine
- Metoprolol
- Midazolam
- Omeprazole
- Warfarin
- Administration, within 14 days before baseline or within a period of 5 times the elimination half-life of the medication before baseline, whichever is longer, of any medication that is a known inducer or inhibitor of either one or more of the following CYP enzymes: CYP3A4, CYP2C19, CYP2C9, CYP2D6, and CYP1A2.
- Administration, within 14 days before baseline or within a period of 5 times the elimination half-life of the medication before baseline, whichever is longer, of:
- Caffeine
- Metoprolol
- Midazolam
- Omeprazole
- Warfarin.
- Consumption of any 1 or more of the following food items and/or beverages within 1 week prior to baseline:
- Grapefruit or grapefruit juice, apple or apple juice, orange or orange juice, lemons or lemon juice, limes or lime juice
- Vegetables from the mustard green family (eg, broccoli)
- Charbroiled meats
- Caffeinated beverages, foods or drugs containing caffeine as well as decaffeinated coffee.
- Participants who are not willing to abstain from the consumption of these food items and/or beverages for certain periods during the study (Day 1 to Day 8, and Day 168 to Day 183) will also be excluded.
- History of excessive consumption of beverages containing caffeine (more than 4 cups or glasses per day). Participants who are not willing to abstain from the consumption of caffeine within 1 week prior to baseline, Day 1 to Day 8, and Day 168 to Day 183 will also be excluded.
- Female participants who are using any form of hormonal contraceptives (eg, oral, injectables, implants, patches, rings, hormone-impregnated IUDs) for birth control.
- Have previously completed or withdrawn from this study or any other study investigating amlitelimab or have previously received a dose of an investigational drug within the past 90 days or 5 half-lives, whichever is longer, prior to Check-in (Day -1).
- Concurrent participation in any other clinical study, including non-interventional studies.
- Participants positive for human immunodeficiency virus; participants with any of the following results at Screening (Visit 1): presence of HBsAg with or without HBV DNA PCR test or presence of antibody to hepatitis B core antigen (HBcAb) or presence of antibody to HBsAg with positive HBV DNA PCR test; positive hepatitis C total antibody confirmed by positive Hepatitis C virus RNA.
- Known or suspected hypersensitivity to any of the study interventions (amlitelimab, CYP substrates [cocktail compounds]) or excipients, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Drug-drug Interaction Study to Investigate the Effects of Amlitelimab on the Pharmacokinetics of Selected Cytochrome P450 Substrates in Adult Participants With Moderate-to-severe Atopic Dermatitis
This is an open-label, single group, 2-period, Phase 1, single-sequence study. The study duration will be up to 342 days. The treatment period will be up to Week 29, where Week 29 is defined as End of Treatment (last amlitelimab administration at Week 25).
The number of visits will be 23 or 21 visits for participants who decide to continue amlitelimab therapy in the long-term extension study LTS17367 (RIVER-AD) study.
- Conditions
- Dermatitis Atopic
- Being tested
- Amlitelimab, Midazolam, Caffeine, Metoprolol, Omeprazole
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlitelimabDrug
Also called SAR445229
Pharmaceutical form: Injection solution Route of administration: SC injection
MidazolamDrug
Pharmaceutical form: Solution Route of administration: Oral
CaffeineDrug
Pharmaceutical form: Tablet Route of administration: Oral
MetoprololDrug
Pharmaceutical form: Tablet Route of administration: Oral
OmeprazoleDrug
Pharmaceutical form: Capsule Route of administration: Oral
WarfarinDrug
Pharmaceutical form: Tablet Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Amlitelimab and CYP substrates | Experimental | A single oral dose of a CYP450 substrates cocktail which will include caffeine, metoprolol, midazolam, omeprazole, and warfarin will be administered.
A single dose of amlitelimab will then be administered on several days. A single oral dose of CYP450 substrates cocktail in combination with the last single dose of amlitelimab. Receives: Drug: Amlitelimab; Drug: Midazolam; Drug: Caffeine; Drug: Metoprolol; Drug: Omeprazole; Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC and AUClast for CYP substrates
AUC = area under the serum/plasma concentration curve; AUClast = area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast.
Measured: Baseline (Day 1 to Day 8) and Day 176 to Day 183
Secondary outcomes (5)
Incidence of treatment-emergent adverse events, serious adverse events, adverse event of special interest, and potentially clinically significant abnormality.
Measured: Baseline through Day 316
Serum amlitelimab concentrations (Ctrough) measured.
Ctrough = plasma concentration pre-dose
Measured: Day 8 through Day 316
Tmax, t1/2z, and tlast of CYP substrates alone and co-administered with amlitelimab
tmax = time to reach the maximum plasma concentration observed t1/2z = terminal half-life associated with the terminal slope tlast= time corresponding to the last concentration above the limit of quantification
Measured: Baseline (Day 1 to Day 8) and Day 176 to Day 183
Cmax of CYP substrates alone and co-administered with amlitelimab
Cmax = maximum plasma concentration observed.
Measured: Baseline (Day 1 to Day 8) and Day 176 to Day 183
Incidence of anti-drug antibodies of amlitelimab.
Measured: Baseline through Day 316
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start20 Nov 2024
- Primary completion21 Nov 2025
- Study completion2 Apr 2026
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.
- More trials run by SanofiThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686628
- Sponsor's protocol ID
- INT18404
- Other IDs
- U1111-1303-3406, 2024-513495-17
- Status last verified
- Apr 2026
- First submitted
- 11 Nov 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Drug-drug Interaction Study to Investigate the Effects of Amlitelimab on the Pharmacokinetics of Selected Cytochrome P450 Substrates in Adult Participants With Moderate-to-severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06686628
- Acronym / sponsor ID
- INT18404
- Conditions
- Dermatitis Atopic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 13 Nov 2024 (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.
This is an open-label, single group, 2-period, Phase 1, single-sequence study. The study duration will be up to 342 days. The treatment period will be up to Week 29, where Week 29 is defined as End of Treatment (last amlitelimab administration at Week 25).
The number of visits will be 23 or 21 visits for participants who decide to continue amlitelimab therapy in the long-term extension study LTS17367 (RIVER-AD) study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amlitelimab and CYP substrates | Experimental | Drug: Amlitelimab, Drug: Midazolam, Drug: Caffeine, Drug: Metoprolol, Drug: Omeprazole, Drug: WarfarinA single oral dose of a CYP450 substrates cocktail which will include caffeine, metoprolol, midazolam, omeprazole, and warfarin will be administered. A single dose of amlitelimab will then be administered on several days. A single oral dose of CYP450 substrates cocktail in combination with the last single dose of amlitelimab. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Male or female participant aged 18 to 65 years (inclusive), at the time of the informed consent is signed.
- Participants must have AD as defined by the American Academy of Dermatology Consensus Criteria (2014) for 1 year or longer before signing of informed consent.
- The EASI score ≥16 at Screening and Check-in (Day -1).
- vIGA-AD score ≥3 (on the 0 to 4 vIGA-AD scale) at Screening and Check-in (Day -1).
Key exclusion criteria (37 listed)
- Known history of significant immunosuppression or suspected current significant immunosuppression, including history of invasive opportunistic, or helminthic infections.
- Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and cured for more than 5 years prior to baseline).
- Any concomitant illness that would, in the Investigator's opinion, inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure, and pulmonary disease.
- Any medical condition which, in the Investigator's opinion may present an unreasonable risk to the study participants as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments.
- Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline (1 week in the event of superficial skin infections) and any infection which as per Investigator's opinion precludes the participant's participation in the study or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals at Screening or Check--in (Day -1).
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 |
|---|---|---|
| AmlitelimabAlso: SAR445229Pharmaceutical form: Injection solution Route of administration: SC injection | Drug | Amlitelimab and CYP substrates |
| MidazolamPharmaceutical form: Solution Route of administration: Oral | Drug | Amlitelimab and CYP substrates |
| CaffeinePharmaceutical form: Tablet Route of administration: Oral | Drug | Amlitelimab and CYP substrates |
| MetoprololPharmaceutical form: Tablet Route of administration: Oral | Drug | Amlitelimab and CYP substrates |
| OmeprazolePharmaceutical form: Capsule Route of administration: Oral | Drug | Amlitelimab and CYP substrates |
| WarfarinPharmaceutical form: Tablet Route of administration: Oral | Drug | Amlitelimab and CYP substrates |
Primary outcome
AUC and AUClast for CYP substrates
Time frame: Baseline (Day 1 to Day 8) and Day 176 to Day 183
AUC = area under the serum/plasma concentration curve; AUClast = area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast.
5 secondary outcomes
Incidence of treatment-emergent adverse events, serious adverse events, adverse event of special interest, and potentially clinically significant abnormality.
Time frame: Baseline through Day 316
Serum amlitelimab concentrations (Ctrough) measured.
Time frame: Day 8 through Day 316
Tmax, t1/2z, and tlast of CYP substrates alone and co-administered with amlitelimab
Time frame: Baseline (Day 1 to Day 8) and Day 176 to Day 183
Cmax of CYP substrates alone and co-administered with amlitelimab
Time frame: Baseline (Day 1 to Day 8) and Day 176 to Day 183
Incidence of anti-drug antibodies of amlitelimab.
Time frame: Baseline through Day 316
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 23 Apr 2026.
- INT18404 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
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 Amlitelimab, Midazolam and Caffeine in people with Dermatitis Atopic, run by Sanofi 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 9 inclusion and 37 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 Apr 2026. 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. 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?
AUC and AUClast for CYP substrates (time frame: Baseline (Day 1 to Day 8) and Day 176 to Day 183). 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 23 Apr 2026.