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Plaque PsoriasisPhase 2NCT03442088

Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis Subjects Treated With Apremilast

A Phase 2 study testing Apremilast in people with Plaque Psoriasis, run by University Hospitals Cleveland Medical Center at 1 site in United States.

Completed

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

Official record
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Trial summary

This is an open label pilot study of the impact of treatment with standard dosing of Otezla for 16 weeks on AM-endotype psoriasis patients, identified by elevated (>150% of normal): 1.) Intermediate (CD14++CD16+) monocytes, or 2.) circulating monocyte doublets, or 3.) circulating monocyte-platelet aggregates (MPA). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
Apremilast
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
1 Jun 2018to 30 Sep 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • No healthy volunteers
  • Adult

Who may be able to join

  • Males or females, ≥ 18 and < 60 years of age at the time of signing the informed consent document.
  • Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Patients must exhibit AM-endotype psoriasis patients, identified by elevated (>150% of normal) levels of any one of the following criteria: 1.) Intermediate (CD14++CD16+) monocytes, or 2.) circulating monocyte doublets, or 3.) circulating monocyte-platelet aggregates (MPA).
  • Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening.
  • Have moderate to severe plaque psoriasis at Screening and Baseline as defined by a. BSA ≥5% b. sPGA ≥3 (moderate to severe)
Show all 13Show fewer
  • Must be a candidate for phototherapy and systemic (including Otezla) therapy.
  • Must be in good health (except for psoriasis) as judged by the Investigator, based on medical history and physical examination.
  • Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
  • Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy;
  • OR
  • Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
  • The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or non-latex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on investigational product and for at least 28 days after the last dose of investigational product.

Who cannot join

  • 1. Other than psoriasis, history of any clinically significant (as determined by the Investigator) cardiac (clinically advanced cardiovascular disease including; Stent, past history of MI, thrombotic event or arterial calcification), endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease.
  • 2. Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
  • 3. Any condition, including other inflammatory diseases or dermatologic conditions that confound the ability to interpret data from the study.
  • 4. Prior history of suicide attempt at any time in the subject's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
  • 5. Pregnant or breast feeding.
  • 6. Have failed more than 3 systemic agents for treatment of psoriasis.
Show all 25Show fewer
  • 7. History of allergy to any component of Apremilast.
  • 8. Hepatitis B surface antigen positive at Screening.
  • 9. Anti-hepatitis C antibody positive at Screening.
  • 10. Had a serious infection (including, but not limited to, hepatitis, pneumonia, sepsis, cellulitis, meningitis or pyelonephritis) or have been hospitalized for an infection. Subject must be cured of infection > 4 weeks before Screening.
  • 11. Have a history of, or ongoing, chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (e.g., bronchiectasis), sinusitis, recurrent urinary tract infection (e.g., recurrent pyelonephritis, chronic nonremitting cystitis), an open, draining, or infected skin wound or ulcer.
  • 12. Had a Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to screening.
  • 13. History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (e.g., common variable immunodeficiency disease).
  • 14. Active substance abuse or a history of substance abuse within 6 months prior to Screening.
  • 15. Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment and cure for such infections must have been completed at least 4 weeks prior to Screening.
  • 16. Malignancy or history of malignancy, except for:
  • treated [i.e., cured] basal cell or squamous cell in situ skin carcinomas;
  • treated [i.e., cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years.
  • 17. Topical therapy within 2 weeks of study entry (including, but not limited to, topical corticosteroids, retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol). Exceptions: low-potency corticosteroids to cyclosporine, corticosteroids, methotrexate, retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, fumaric acid esters) will be allowed as background therapy and restricted to treatment of the face, axillae, and groin in accordance with the manufacturers' suggested usage during the course of the study (this restricted usage should be documented). Subjects with scalp psoriasis will be permitted to use coal tar shampoo and/or salicylic acid scalp preparations on scalp lesions. An unmedicated skin moisturizer (eg, Eucerin®) will be also permitted for body lesions only. Subjects should not use these topical treatments within 24 hours prior to the clinic visit.
  • 18. Systemic therapy for psoriasis within 4 weeks prior to study entry (including, but not limited to, cyclosporine, corticosteroids, methotrexate, retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, and fumaric acid esters).
  • 19. Use of phototherapy within 4 weeks prior to study entry.
  • 20. Use of any investigational drug within 4 weeks prior to study entry, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
  • 21. Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources.
  • 22. Prior treatment with Apremilast
  • 23. Inability to wash out from any topical treatment(s) (two weeks prior to entering the study) or all systemic therapies, including orals and biologics (e.g., TNF inhibitors IL-17 inhibitors, IL-12/23 inhibitors, 4 weeks).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: An Investigator Initiated Study of Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis Subjects Treated With Apremilast

This is an open label pilot study of the impact of treatment with standard dosing of Otezla for 16 weeks on AM-endotype psoriasis patients, identified by elevated (>150% of normal): 1.) Intermediate (CD14++CD16+) monocytes, or 2.) circulating monocyte doublets, or 3.) circulating monocyte-platelet aggregates (MPA).

Approximately 25 psoriasis patients with the AM-endotype will be followed during treatment over 16 weeks with 4 monthly individual blood draws will be enrolled. All treated psoriasis subjects will receive apremilast through Week 16.

Being tested
Apremilast

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApremilastDrug

    Also called Otezla

    Apremilast will be given as approved by the FDA for the treatment of moderate to severe plaque psoriasis. An initial dosage titration from Day 1 (10mg) to Day 5 (30mg). Following the titration, the recommended maintenance dosage of 30 mg twice daily taken orally starting on Day 6 will be dispensed, as per labeled indication.

Study groups in NCT03442088
Study groupRoleWhat they receive
Apremilast for Treatment of Psoriasis with the AM-endotypeExperimentalPsoriasis patients with the AM-endotype will be followed during treatment over 16 weeks with 5 monthly individual blood draws will be enrolled.
Receives: Drug: Apremilast

What is being measured

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

  1. The Primary Outcome Measure Will be to Evaluate Change in Aberrant Inflammatory Profiles of Activated Blood Monocytes (Aberrant-monocyte Endotype Patients (AM-endotype).

    For each subject, we will identify a target biomarker of abnormally elevated monocytes, among 1.) intermediate, or 2.) doublets, or 3.) platelet doubles. Each subject will thus have one identified monocyte biomarker for which relative percent change will be its basis for analysis in the primary outcome measure. We will specifically assess change from baseline to 16 weeks by computing relative percent reduction for each subject being treated. Note for example that a change of 1.5% to 1.2% is (1 - (1.2/1.5))*100% = 20% reduction. The median and other summary statistics of these percent change values will be computed. Wilcoxon's signed rank test will be used to evaluate the null hypothesis of the median percent change being 0.

    Measured: Baseline, Week 16

Secondary outcomes (4)

  1. Change in Serum Myeloperoxidase

    To assess change in serum myeloperoxidase in the identified patient AM-endotype computing relative percent reduction for each subject being treated and serum marker. The median and other summary statistics of these percent change values will be computed

    Measured: Baseline, Week 16

  2. Change in TNF Alpha

    To assess change in in the identified patient AM-endotype computing relative percent reduction for each subject being treated and serum marker. The median and other summary statistics of these percent change values will be computed

    Measured: Baseline, Week 16

  3. Change in IL-17

    To assess change in IL-17 in the identified patient AM-endotype computing relative percent reduction for each subject being treated and serum marker. The median and other summary statistics of these percent change values will be computed

    Measured: Baseline, Week 16

  4. Change in Tissue Factor

    To assess change in Tissue Factor in the identified patient AM-endotype computing relative percent reduction for each subject being treated and serum marker. The median and other summary statistics of these percent change values will be computed

    Measured: Baseline, Week 16

Timeline

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

  1. First posted22 Feb 2018
  2. Study start1 Jun 2018
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2021

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is an open label pilot study of the impact of treatment with standard dosing of APM for 16 weeks on AM-endotype psoriasis patients, identified by elevated (\>150% of normal): 1.) Intermediate (CD14++CD16+) monocytes % of cells in circulation, or 2.) circulating monocyte doublets % of adherent monocyte-monocyte pairs, or 3.) circulating monocyte-platelet aggregates (MPA) % monocytes adherent to platelets.
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03442088
Sponsor's protocol ID
07-17-33
Status last verified
Dec 2022
First submitted
11 Oct 2017
Last updated
20 Jan 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ackermann C, Kavanaugh A. Economic burden of psoriatic arthritis. Pharmacoeconomics. 2008;26(2):121-9. doi: 10.2165/00019053-200826020-00003.

    PubMed 18198932

  • Feldman SR, Evans C, Russell MW. Systemic treatment for moderate to severe psoriasis: estimates of failure rates and direct medical costs in a north-eastern US managed care plan. J Dermatolog Treat. 2005 Feb;16(1):37-42. doi: 10.1080/09546630510025941.

    PubMed 15897166

  • Fowler JF, Duh MS, Rovba L, Buteau S, Pinheiro L, Lobo F, Sung J, Doyle JJ, Swensen A, Mallett DA, Kosicki G. The impact of psoriasis on health care costs and patient work loss. J Am Acad Dermatol. 2008 Nov;59(5):772-80. doi: 10.1016/j.jaad.2008.06.043.

    PubMed 19119095

  • Hazard E, Cherry SB, Lalla D, Woolley JM, Wilfehrt H, Chiou CF. Clinical and economic burden of psoriasis. Manag Care Interface. 2006 Apr;19(4):20-6.

    PubMed 16689023

  • Kimball AB, Guerin A, Tsaneva M, Yu AP, Wu EQ, Gupta SR, Bao Y, Mulani PM. Economic burden of comorbidities in patients with psoriasis is substantial. J Eur Acad Dermatol Venereol. 2011 Feb;25(2):157-63. doi: 10.1111/j.1468-3083.2010.03730.x. Epub 2010 Jun 17.

    PubMed 20561129

  • Davidovici BB, Sattar N, Prinz J, Puig L, Emery P, Barker JN, van de Kerkhof P, Stahle M, Nestle FO, Girolomoni G, Krueger JG. Psoriasis and systemic inflammatory diseases: potential mechanistic links between skin disease and co-morbid conditions. J Invest Dermatol. 2010 Jul;130(7):1785-96. doi: 10.1038/jid.2010.103. Epub 2010 May 6.

    PubMed 20445552

  • Kim N, Thrash B, Menter A. Comorbidities in psoriasis patients. Semin Cutan Med Surg. 2010 Mar;29(1):10-5. doi: 10.1016/j.sder.2010.01.002.

    PubMed 20430302

  • Gelfand JM, Shin DB, Neimann AL, Wang X, Margolis DJ, Troxel AB. The risk of lymphoma in patients with psoriasis. J Invest Dermatol. 2006 Oct;126(10):2194-201. doi: 10.1038/sj.jid.5700410. Epub 2006 Jun 1.

    PubMed 16741509

  • Mehta NN, Azfar RS, Shin DB, Neimann AL, Troxel AB, Gelfand JM. Patients with severe psoriasis are at increased risk of cardiovascular mortality: cohort study using the General Practice Research Database. Eur Heart J. 2010 Apr;31(8):1000-6. doi: 10.1093/eurheartj/ehp567. Epub 2009 Dec 27.

    PubMed 20037179

  • Kimball AB, Jacobson C, Weiss S, Vreeland MG, Wu Y. The psychosocial burden of psoriasis. Am J Clin Dermatol. 2005;6(6):383-92. doi: 10.2165/00128071-200506060-00005.

    PubMed 16343026

  • Au L, Meisch JP, Das LM, Binko AM, Boxer RS, Wen AM, Steinmetz NF, Lu KQ. Suppression of Hyperactive Immune Responses Protects against Nitrogen Mustard Injury. J Invest Dermatol. 2015 Dec;135(12):2971-2981. doi: 10.1038/jid.2015.322. Epub 2015 Aug 19.

    PubMed 26288355

  • Ziegler-Heitbrock HW. Heterogeneity of human blood monocytes: the CD14+ CD16+ subpopulation. Immunol Today. 1996 Sep;17(9):424-8. doi: 10.1016/0167-5699(96)10029-3. No abstract available.

    PubMed 8854561

  • Martinez FO. The transcriptome of human monocyte subsets begins to emerge. J Biol. 2009;8(11):99. doi: 10.1186/jbiol206. Epub 2009 Dec 23.

    PubMed 20067595

  • Ancuta P, Liu KY, Misra V, Wacleche VS, Gosselin A, Zhou X, Gabuzda D. Transcriptional profiling reveals developmental relationship and distinct biological functions of CD16+ and CD16- monocyte subsets. BMC Genomics. 2009 Aug 27;10:403. doi: 10.1186/1471-2164-10-403.

    PubMed 19712453

  • Wong KL, Tai JJ, Wong WC, Han H, Sem X, Yeap WH, Kourilsky P, Wong SC. Gene expression profiling reveals the defining features of the classical, intermediate, and nonclassical human monocyte subsets. Blood. 2011 Aug 4;118(5):e16-31. doi: 10.1182/blood-2010-12-326355. Epub 2011 Jun 7.

    PubMed 21653326

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apremilast in people with Plaque Psoriasis, run by University Hospitals Cleveland Medical Center 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 13 inclusion and 25 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 20 Jan 2023. 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?

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?

Yes. Results are posted in the registry (first posted 20 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Primary Outcome Measure Will be to Evaluate Change in Aberrant Inflammatory Profiles of Activated Blood Monocytes (Aberrant-monocyte Endotype Patients (AM-endotype). (time frame: Baseline, Week 16). 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 NCT03442088, which also lists 45 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 20 Jan 2023.

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