Apremilast for RAS

NCT03690544 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 18-002914
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Determination of treatment efficacy and safety of Apremilast in patients with RAS

Conditions

Recurrent Aphthous Stomatitis

Outcome Measures

Primary Outcomes (3)

• Duration of RAS Lesions

  The total length of time (duration) subjects experienced RAS lesions. Measured in weeks

  24 weeks

• Change in Number of RAS Lesions

  Number of participants with fewer oral ulcers at Week 24 compared to Baseline

  baseline, 24 weeks

• Duration of the Remission Period Between Ulcer Episodes

  The length of time of remission of RAS lesions experienced by the subjects. As measured in months.

  24 weeks

Secondary Outcomes (3)

• Adverse Events

  24 weeks

• Discontinuation of Study Participants

  24 weeks

• Change in Visual Analog Scale Pain Score (VAS) From Baseline to 16 Weeks and Baseline to 24 Weeks.

  baseline, 16 weeks, 24 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

Apremilast 30mg orally twice daily for 16 weeks, sixteen weeks on active study. Post treatment follow-up period of 8 weeks, in the Treatment of Subjects with Severe Recurrent Aphthous Stomatitis (RAS)

Drug: Apremilast 30mg

Interventions

Apremilast 30mg DRUG

Apremilast is an oral small-molecule inhibitor of phosphodiesterase (PDE) 4 that works intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators. PDE 4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-alfa, IL-23, IL-17 and other inflammatory cytokines. Cyclic AMP also modulates levels of anti-inflammatory cytokines such as IL-10. Apremilast has immunomodulatory activity and, therefore, has the potential to be effective in the treatment of RAS.

Single Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects between 18 and 70 years of age
• Oral ulcers that occurred at least monthly in the 6 month period prior to enrollment
• Had at least 2 oral ulcers in the 4 weeks prior to enrollment at baseline
• At least 3 oral ulcers during an ulcer flare
• Patients must be candidates for systemic therapy for the treatment of oral ulcers, those that are considered unsuitable for topical therapy alone based on severity of disease, or whose oral ulcers cannot be adequately controlled with topical therapy.
• Female premenopausal subjects must use one of the approved contraceptive options while taking apremilast and for at least 28 days after administration of the last dose of apremilast
• Patients are able and willing to provide written informed consent after the nature of the study is fully explained.
• No evidence of systemic disease

You may not qualify if:

• Prior use of apremilast.
• Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
• Having received concomitant immune modulating therapy 12 weeks prior to enrollment, systemic steroids 6 weeks prior to enrollment or topical steroids within 4 weeks prior to enrollment.
• Pregnant women or breast-feeding mothers.
• Systemic or opportunistic fungal infection.
• Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (tuberculosis and atypical mycobacterial disease, hepatitis B and C and herpes zoster, histoplasmosis, coccidiomycosis) or any major episode of infection requiring hospitalization or treatment with IV or oral antibiotics within 4 weeks of the screening phase.
• History of positive test for, or any clinical suspicion of, human immunodeficiency virus (HIV), or congenital or acquired immunodeficiency.
• History of depression.
• Malignancy or history of malignancy, except for:
• a - treated (ie, cured) basal cell or squamous cell in situ skin carcinomas; b - treated (ie, cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years.
• Other than disease under study, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
• 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.
• 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.
• Active substance abuse or a history of substance abuse within 6 months prior to screening.
• Presence of any of the following vitamin deficiencies - B1, B2, B6, B12, vitamin C, zinc, folate, iron.

Sponsors & Collaborators

• Mayo Clinic: lead
• Celgene: collaborator

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Stomatitis, Aphthous

Interventions

apremilast

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Alison J. Bruce, M.B., Ch.B.
• Organization: Mayo Clinic

Bruce.Alison@mayo.edu

904-953-6402

Study Officials

• Alison J Bruce

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Apremilast 30mg orally twice daily for 16 weeks

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: October 1, 2018
• Study Start: October 12, 2018
• Primary Completion: July 14, 2021
• Study Completion: July 14, 2021
• Last Updated: July 14, 2022
• Results First Posted: July 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)