PsoriasisPhase 1NCT07908641
Comparing the Extent to Which Apremilast is Made Available in the Body After Administration as an Extended-release or Immediate-release Formulation
A Phase 1 study testing Apremilast XR and Apremilast IR in people with Psoriasis and Arthritis, Psoriatic, run by Amgen.
Trial summary
The main objective of this study is to compare the relative bioavailability, safety, and tolerability of extended-release and immediate-release apremilast formulations in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Arthritis, Psoriatic, Oral Ulcer
- What is being tested?
- Apremilast XR and Apremilast IR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 18 Nov 2026to 10 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female participants, 18 to 60 years of age, inclusive.
- Body mass index (BMI) between 18.0 and 32.0 kg/m^²(kilograms per meter square.), inclusive.
- In good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory evaluations.
- Female participants must not be pregnant or breastfeeding.
- Participants of reproductive potential must agree to follow protocol-specified contraception requirements.
Who cannot join
- Clinically significant medical condition or disease that may pose a safety risk or interfere with study participation or interpretation of study results.
- Clinically significant cardiovascular disease or ECG abnormality, including clinically significant arrhythmia or prolonged QTcF(QT Interval Corrected for Heart Rate Using Fridericia's Formula).
- Significant gastrointestinal disease, gastrointestinal surgery that could affect drug absorption, malabsorption syndrome, or inability to swallow oral medication.
- History of suicidal ideation, suicide attempt, or major psychiatric illness within 6 months before informed consent.
- Malignancy within the previous 5 years, except for protocol-specified nonmelanoma skin cancers or cervical carcinoma in situ.
- Known hypersensitivity, intolerance, or allergy to apremilast.
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- Clinically significant renal or hepatic impairment, including estimated glomerular filtration rate (eGFR) <70 mL/min/1.73 m^²(millilitres per minute per 1.73 square meters) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 × the upper limit of normal.
- Positive testing for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, except for protocol-specified hepatitis B results consistent with prior vaccination or prior infection.
- Use of prohibited prescription or over-the-counter medications, herbal medicines, vitamins, or supplements within the protocol-specified period before study entry.
- Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, before check-in.
- Previous participation in this study or another study investigating apremilast, or previous receipt of apremilast.
- History of alcohol or drug abuse within the protocol-specified periods, or positive alcohol or illicit drug testing.
- Use of tobacco- or nicotine-containing products within 3 months before check-in.
- Recent blood, plasma, or platelet donation outside the protocol-specified limits.
- Poor peripheral venous access.
- Unable or unwilling to comply with protocol-required dietary, lifestyle, or other study restrictions.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Open-label, Crossover Study to Evaluate the Relative Bioavailability of Apremilast Extended-release and Immediate Release Formulations in Healthy Adult Participants.
The main objective of this study is to compare the relative bioavailability, safety, and tolerability of extended-release and immediate-release apremilast formulations in healthy participants.
- Conditions
- Psoriasis, Arthritis, Psoriatic, Oral Ulcer
- Being tested
- Apremilast XR, Apremilast IR
- Keywords
- Apremilast, Pharmacokinetics, Bioavailability, Extended-release, Immediate-release, Crossover Study
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic, Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apremilast XRDrug
Also called AMG 407, Otezla
Participants will receive apremilast XR orally.
Apremilast IRDrug
Also called AMG 407, Otezla
Participants will receive apremilast IR orally .
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence AB | Experimental | Participants will be administered apremilast in the following sequence:
Period 1 (treatment A) - apremilast extended-release (XR) oral tablets given once daily (QD).
Period 2 (treatment B) - apremilast immediate-release (IR) oral tablets given twice daily(BID). Receives: Drug: Apremilast XR; Drug: Apremilast IR |
| Treatment Sequence BA | Active comparator | Participants will be administered apremilast in the following sequence:
Period 1 (treatment B) - apremilast IR oral tablets given BID. Period 2 (treatment A) -. apremilast XR oral tablets given QD. Receives: Drug: Apremilast XR; Drug: Apremilast IR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero extrapolated to Infinity (AUCinf) of Apremilast.
Measured: Pre-dose on Day 1 through Day 4 of each treatment period
Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Apremilast
Measured: Pre-dose on Day 1 through Day 4 of each treatment period
Maximum Observed Plasma Concentration (Cmax) of Apremilast.
Measured: Pre-dose on Day 1 through Day 4 of each treatment period
Secondary outcomes (2)
Number of participants who experience treatment-emergent adverse events .
Measured: Baseline through end of study (up to approximately 12 days)
Number of participants who experience Serious adverse events
Measured: From Screening (Day-28) through end of study (up to approximately 40 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start18 Nov 2026 (estimated)
- Primary completion10 Jan 2027 (estimated)
- Study completion10 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908641
- Sponsor's protocol ID
- 20220137
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Crossover Study to Evaluate the Relative Bioavailability of Apremilast Extended-release and Immediate Release Formulations in Healthy Adult Participants.
- ClinicalTrials.gov ID
- NCT07908641
- Acronym / sponsor ID
- 20220137
- Conditions
- Psoriasis, Arthritis, Psoriatic, Oral Ulcer
- Keywords
- Apremilast, Pharmacokinetics, Bioavailability, Extended-release, Immediate-release, Crossover Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2026 (estimated)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 2 Nov 2026 (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 main objective of this study is to compare the relative bioavailability, safety, and tolerability of extended-release and immediate-release apremilast formulations in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence AB | Experimental | Drug: Apremilast XR, Drug: Apremilast IRParticipants will be administered apremilast in the following sequence: Period 1 (treatment A) - apremilast extended-release (XR) oral tablets given once daily (QD). Period 2 (treatment B) - apremilast immediate-release (IR) oral tablets given twice daily(BID). |
| Treatment Sequence BA | Active comparator | Drug: Apremilast XR, Drug: Apremilast IRParticipants will be administered apremilast in the following sequence: Period 1 (treatment B) - apremilast IR oral tablets given BID. Period 2 (treatment A) -. apremilast XR oral tablets given QD. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female participants, 18 to 60 years of age, inclusive.
- Body mass index (BMI) between 18.0 and 32.0 kg/m^²(kilograms per meter square.), inclusive.
- In good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory evaluations.
- Female participants must not be pregnant or breastfeeding.
- Participants of reproductive potential must agree to follow protocol-specified contraception requirements.
Key exclusion criteria (16 listed)
- Clinically significant medical condition or disease that may pose a safety risk or interfere with study participation or interpretation of study results.
- Clinically significant cardiovascular disease or ECG abnormality, including clinically significant arrhythmia or prolonged QTcF(QT Interval Corrected for Heart Rate Using Fridericia's Formula).
- Significant gastrointestinal disease, gastrointestinal surgery that could affect drug absorption, malabsorption syndrome, or inability to swallow oral medication.
- History of suicidal ideation, suicide attempt, or major psychiatric illness within 6 months before informed consent.
- Malignancy within the previous 5 years, except for protocol-specified nonmelanoma skin cancers or cervical carcinoma in situ.
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 |
|---|---|---|
| Apremilast XRAlso: AMG 407, OtezlaParticipants will receive apremilast XR orally. | Drug | Treatment Sequence AB, Treatment Sequence BA |
| Apremilast IRAlso: AMG 407, OtezlaParticipants will receive apremilast IR orally . | Drug | Treatment Sequence AB, Treatment Sequence BA |
Primary outcome
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero extrapolated to Infinity (AUCinf) of Apremilast.
Time frame: Pre-dose on Day 1 through Day 4 of each treatment period
Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Apremilast
Time frame: Pre-dose on Day 1 through Day 4 of each treatment period
Maximum Observed Plasma Concentration (Cmax) of Apremilast.
Time frame: Pre-dose on Day 1 through Day 4 of each treatment period
2 secondary outcomes
Number of participants who experience treatment-emergent adverse events .
Time frame: Baseline through end of study (up to approximately 12 days)
Number of participants who experience Serious adverse events
Time frame: From Screening (Day-28) through end of study (up to approximately 40 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Apremilast XR and Apremilast IR in people with Psoriasis and Arthritis, Psoriatic, run by Amgen.
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 16 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero extrapolated to Infinity (AUCinf) of Apremilast. (time frame: Pre-dose on Day 1 through Day 4 of each treatment period). 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?
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 2 Nov 2026.