PsoriasisEarly Phase 1NCT05601492
Adherence to Otezla
A Early Phase 1 study testing Reminder Text Intervention with apremilast and Extended Consultation for apremilast in people with Psoriasis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Most people with psoriasis have very limited disease, yet that disease may still have a large impact on their lives. While limited psoriasis may be amenable to topical treatment, patients are exceptionally poorly adherent to topical treatment, especially over the long run. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Reminder Text Intervention with apremilast and Extended Consultation for apremilast
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2025to Feb 2026
- Phase
- Early 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 18 years or older
- Diagnosis of mild psoriasis with Otezla recommendation
- Non-pregnant
- English speaking
Who cannot join
- Under 18 years of age
- Not diagnosis of mild psoriasis
- Pregnant
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Adherence to Otezla in Patients With Mild Psoriasis
Most people with psoriasis have very limited disease, yet that disease may still have a large impact on their lives. While limited psoriasis may be amenable to topical treatment, patients are exceptionally poorly adherent to topical treatment, especially over the long run.
Read the detailed description
Psoriasis patients prefer oral treatments and are more adherent to orals than to topicals, but adherence to oral treatment of psoriasis may still be limited, compromising treatment outcomes. How well the medication works in the patients who take treatment regularly is not well characterized.
- Conditions
- Psoriasis
- Being tested
- Otezla - Standard Care, Reminder Text Intervention with apremilast, Extended Consultation for apremilast
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otezla - Standard CareDrug
Also called Apremilast
The participant will be given their medication with the electronic adapter cap on it and asked to return for the follow-up visit
Reminder Text Intervention with apremilastBehavioural
Also called Otezla
Participants will receive a weekly electronic text/email-based intervention that is designed to promote better adherence to treatment in addition to receiving their medication with the electronic adapter cap on it.
Extended Consultation for apremilastBehavioural
Also called Otezla
Participants will be given their medication with the electronic adapter cap on it and will receive an initial patient consult intervention, which will focus on medication education and setting expectations of what to anticipate with usage of the prescribed medication
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Standard of Care | Active comparator | Participant will be given the medication with an electronic monitoring cap attached and a return appointment for a standard of care regular visit Receives: Drug: Otezla - Standard Care; Behavioral: Reminder Text Intervention with apremilast; Behavioral: Extended Consultation for apremilast |
| Arm 2 - Reminder text | Experimental | Participant will be given the medication with an electronic monitoring cap attached and receive weekly electronic text/email-based reporting intervention that is designed to promote better adherence to treatment (to help assure that the study have subjects who have excellent adherence. Having patients report their progress on a regular basis promotes better treatment adherence, perhaps by creating the same sense of accountability promoted by regular office visits Receives: Behavioral: Reminder Text Intervention with apremilast |
| Arm 3 - Initial patient consult | Experimental | Participant will be given the medication with an electronic monitoring cap attached and will receive an initial patient consultation intervention, which will focus on the prescribed medication education and setting expectations of what to anticipate with usage of the medication Receives: Behavioral: Extended Consultation for apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence Outlier
Identify adherence outliers (high and low adherence). Adherence will be determined by the data retrieved from the electronic monitor that is placed on the medication bottle to provide the days and times the bottle is opened to take the medication.
Measured: Month 6
Secondary outcomes (2)
Difference of Efficacy among high adherent subjects
As a secondary outcome, we will compare psoriasis treatment outcomes (efficacy) between the most and least adherent patients. Measures for comparing efficacy between high vs low adherence subjects will be percent of subjects with Investigator Global Assessment (IGA) of clear/almost clear - The IGA is a five-point scale that provides a global clinical assessment of Atopic Dermatitis (AD) severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe Atopic Dermatitis (AD). A decrease in score relates to an improvement in signs and symptoms.
Measured: Month 6
Difference of Safety among low adherent subjects
As a secondary outcome, we will compare psoriasis treatment outcomes (safety) between the most and least adherent patients. Measures for comparing safety between high vs low adherence subjects will be percent of subjects with Investigator Global Assessment (IGA) of clear/almost clear - The IGA is a five-point scale that provides a global clinical assessment of Atopic Dermatitis (AD) severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe Atopic Dermatitis (AD). A decrease in score relates to an improvement in signs and symptoms.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study startJun 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionFeb 2026 (estimated)
Why it stopped: Terminated IRB approval 6/26/2024, study was never initiated or activated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization 1:1:1
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Steven R Feldman, MD, PhD, Principal investigator, Wake Forest University Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601492
- Sponsor's protocol ID
- IRB00088889
- Status last verified
- May 2025
- First submitted
- 13 Oct 2022
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Salisbury KR, Ranpariya VK, Feldman SR. Accountability in reminder-based adherence interventions: A review. Patient Educ Couns. 2022 Aug;105(8):2645-2652. doi: 10.1016/j.pec.2021.12.009. Epub 2021 Dec 15.
PubMed 34953618Okwundu N, Cardwell LA, Cline AE, Richardson IM, Feldman SR. Adherence to topical treatment can improve treatment-resistant moderate psoriasis. Cutis. 2020 Feb;105(2):89-91;E2;E3.
PubMed 32186523Alinia H, Moradi Tuchayi S, Smith JA, Richardson IM, Bahrami N, Jaros SC, Sandoval LF, Farhangian ME, Anderson KL, Huang KE, Feldman SR. Long-term adherence to topical psoriasis treatment can be abysmal: a 1-year randomized intervention study using objective electronic adherence monitoring. Br J Dermatol. 2017 Mar;176(3):759-764. doi: 10.1111/bjd.15085. Epub 2016 Nov 29.
PubMed 27664969West C, Narahari S, O'Neill J, Davis S, Huynh M, Clark A, Boles A, Feldman SR. Adherence to adalimumab in patients with moderate to severe psoriasis. Dermatol Online J. 2013 May 15;19(5):18182.
PubMed 24011280Yentzer BA, Wood AA, Sagransky MJ, O'Neill JL, Clark AR, Williams LL, Feldman SR. An Internet-based survey and improvement of acne treatment outcomes. Arch Dermatol. 2011 Oct;147(10):1223-4. doi: 10.1001/archdermatol.2011.277. No abstract available.
PubMed 22006146
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Otezla in Patients With Mild Psoriasis
- ClinicalTrials.gov ID
- NCT05601492
- Acronym / sponsor ID
- IRB00088889
- Conditions
- Psoriasis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated IRB approval 6/26/2024, study was never initiated or activated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Jun 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 1 Nov 2022 (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.
Most people with psoriasis have very limited disease, yet that disease may still have a large impact on their lives. While limited psoriasis may be amenable to topical treatment, patients are exceptionally poorly adherent to topical treatment, especially over the long run.
Detailed description
Psoriasis patients prefer oral treatments and are more adherent to orals than to topicals, but adherence to oral treatment of psoriasis may still be limited, compromising treatment outcomes. How well the medication works in the patients who take treatment regularly is not well characterized.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomization 1:1:1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Standard of Care | Active comparator | Drug: Otezla - Standard Care, Behavioral: Reminder Text Intervention with apremilast, Behavioral: Extended Consultation for apremilastParticipant will be given the medication with an electronic monitoring cap attached and a return appointment for a standard of care regular visit |
| Arm 2 - Reminder text | Experimental | Behavioral: Reminder Text Intervention with apremilastParticipant will be given the medication with an electronic monitoring cap attached and receive weekly electronic text/email-based reporting intervention that is designed to promote better adherence to treatment (to help assure that the study have subjects who have excellent adherence. Having patients report their progress on a regular basis promotes better treatment adherence, perhaps by creating the same sense of accountability promoted by regular office visits |
| Arm 3 - Initial patient consult | Experimental | Behavioral: Extended Consultation for apremilastParticipant will be given the medication with an electronic monitoring cap attached and will receive an initial patient consultation intervention, which will focus on the prescribed medication education and setting expectations of what to anticipate with usage of the medication |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult 18 years or older
- Diagnosis of mild psoriasis with Otezla recommendation
- Non-pregnant
- English speaking
Key exclusion criteria (4 listed)
- Under 18 years of age
- Not diagnosis of mild psoriasis
- Pregnant
- Non-English speaking
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 |
|---|---|---|
| Otezla - Standard CareAlso: ApremilastThe participant will be given their medication with the electronic adapter cap on it and asked to return for the follow-up visit | Drug | Arm 1 - Standard of Care |
| Reminder Text Intervention with apremilastAlso: OtezlaParticipants will receive a weekly electronic text/email-based intervention that is designed to promote better adherence to treatment in addition to receiving their medication with the electronic adapter cap on it. | Behavioural | Arm 1 - Standard of Care, Arm 2 - Reminder text |
| Extended Consultation for apremilastAlso: OtezlaParticipants will be given their medication with the electronic adapter cap on it and will receive an initial patient consult intervention, which will focus on medication education and setting expectations of what to anticipate with usage of the prescribed medication | Behavioural | Arm 1 - Standard of Care, Arm 3 - Initial patient consult |
Primary outcome
Medication Adherence Outlier
Time frame: Month 6
Identify adherence outliers (high and low adherence). Adherence will be determined by the data retrieved from the electronic monitor that is placed on the medication bottle to provide the days and times the bottle is opened to take the medication.
2 secondary outcomes
Difference of Efficacy among high adherent subjects
Time frame: Month 6
Difference of Safety among low adherent subjects
Time frame: Month 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Background: PubMed 34953618Salisbury KR, Ranpariya VK, Feldman SR. Accountability in reminder-based adherence interventions: A review. Patient Educ Couns. 2022 Aug;105(8):2645-2652. doi: 10.1016/j.pec.2021.12.009. Epub 2021 Dec 15.
- Background: PubMed 32186523Okwundu N, Cardwell LA, Cline AE, Richardson IM, Feldman SR. Adherence to topical treatment can improve treatment-resistant moderate psoriasis. Cutis. 2020 Feb;105(2):89-91;E2;E3.
- Background: PubMed 27664969Alinia H, Moradi Tuchayi S, Smith JA, Richardson IM, Bahrami N, Jaros SC, Sandoval LF, Farhangian ME, Anderson KL, Huang KE, Feldman SR. Long-term adherence to topical psoriasis treatment can be abysmal: a 1-year randomized intervention study using objective electronic adherence monitoring. Br J Dermatol. 2017 Mar;176(3):759-764. doi: 10.1111/bjd.15085. Epub 2016 Nov 29.
- Background: PubMed 24011280West C, Narahari S, O'Neill J, Davis S, Huynh M, Clark A, Boles A, Feldman SR. Adherence to adalimumab in patients with moderate to severe psoriasis. Dermatol Online J. 2013 May 15;19(5):18182.
- Background: PubMed 22006146Yentzer BA, Wood AA, Sagransky MJ, O'Neill JL, Clark AR, Williams LL, Feldman SR. An Internet-based survey and improvement of acne treatment outcomes. Arch Dermatol. 2011 Oct;147(10):1223-4. doi: 10.1001/archdermatol.2011.277. No abstract available.
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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.
Steven R Feldman, MD, PhD principal investigator
Wake Forest University Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Reminder Text Intervention with apremilast and Extended Consultation for apremilast in people with Psoriasis, run by Wake Forest University Health Sciences at 1 site in United States.
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 4 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: withdrawn, as of the sponsor's last update on 29 May 2025. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was withdrawn before enrolling participants, so there are no results.
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?
Medication Adherence Outlier (time frame: Month 6). 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 NCT05601492, which also lists 5 linked publications.
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 29 May 2025.