Trials Sponsors Conditions Drugs Pricing

Conditions

Patients with severe forms of Recurrent Aphthous Stomatitis (RAS)Recurrent Aphtous Stomatitis

Outcome Measures

Primary Outcomes (2)

Presence of oral ulcer during clinical examination
Presence or absence of oral ulcer
Week 12
Presence of oral ulcer during clinical examination
Presence or absence of oral ulcer
Week 14

Secondary Outcomes (5)

Number of oral ulcer during clinical examination
Week 12
Number of oral ulcer during clinical examination
Week 14
Difference from baseline in quality of life
Week 14
Occurrence since baseline of severe and adverse events
Week 14
Occurrence since baseline of non-severe adverse events
Week 14

Study Arms (2)

Apremilast

EXPERIMENTAL

apremilast: 30 mg twice daily during a 12 week double blind placebo controlled period, then 30 mg twice daily during an additional 12 week active treatment period

Drug: Apremilast

Placebo

PLACEBO COMPARATOR

Placebo: 30 mg twice daily during the initial 12 week double blind placebo controlled period

Drug: Placebo oral tablet

Interventions

ApremilastDrug

Apremilast: 30 mg twice daily during a 12 week double blind placebo controlled period, then 30 mg twice daily during an additional 12 week active treatment period

Apremilast

Placebo oral tabletDrug

Placebo: 30 mg twice daily during the initial 12 week double blind placebo controlled period,

Placebo

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
APREMILAST
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record
Formulated product
RACECADOTRIL
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

APREMILAST
Named ingredient: apremilast
View registry record
RACECADOTRIL
Named ingredient: racecadotril
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

\. Male or female patients aged ≥18 years old with severe primary RAS resistant to colchicine prescribed at a dose of 1mg/day or more for at least 3 months, or intolerant to colchicine
Severity of primary oral aphtous ulcer is defined by the presence of at least one of the following criteria:

Sponsors & Collaborators

Centre Hospitalier Universitaire Rouen
Type not reportedlead
University Hospital, Rouen
Otherlead

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Sites (21)

Chu Amiens

Amiens, 80054, France

NOT_YET_RECRUITING

Guillaume Chaby, DrCONTACT03 22 45 58 41 Guillaume.chaby@chu-amiens.fr

Guillaume Chaby, DrPRINCIPAL INVESTIGATOR

Ap-Hp Avicenne

Bobigny, 93000, France

RECRUITING

Christelle Leroux, DrCONTACT01 49 81 25 12

MeSH Terms

Interventions

apremilast

Study Officials

Pascal JOLY, Pr
University Hospital, Rouen
PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal JOLY, Pr

CONTACT

+3323288 pascal.joly@chu-rouen.fr

Julien BLOT

CONTACT

+3323288

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details: double blind study
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 13, 2019

First Posted

January 13, 2020

Study Start

April 10, 2022

Actual (reported)

Primary Completion

December 2026

Estimated

You may not qualify if:

Patient has any significant medical condition, significant laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
Patient has secondary RAS (e.g., celiac disease, Crohn's disease, ulcerative colitis, relapsing polychondritis, PFAPFA, AIDS…).
Depression and suicidal ideation
Co-medication with a cytochrome P450 3A4 (CYP3A4) enzyme inducer ( especially, rifampicin and most anti-epileptic drugs (e.g. carbamazepine, phenytoin)
Severely underweight patient (BMI \< 18.5 kg/m2)
Patient cannot be followed regularly.
Patient has any other inflammatory oral disease, which confounds the ability to interpret data from the study (ie, lichen planus, auto immune bullous diseases with oral involvement),
Patient has any medical condition that requires systemic treatment which may confound the ability to interpret data from the study (ie, lupus erythematosus, rheumatoid arthritis...)
Patient is currently enrolled in any other therapeutic trial.
Other than RAS, subject has 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.
Malignancy or history of malignancy or myeloproliferative or lymphoproliferative disease within the past 5 years, except for treated (ie, cured) basal cell or squamous cell carcinomas, in situ cervix carcinoma, or any situation in which the oncologist in charge of the patient considers that oncologic risk allows the use of apremilast.
Patient with positive blood test for HIV.
Any bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed and the infection cured, at least 4 weeks prior to Screening and no new or recurrent infections prior to the Baseline Visit.
Patient has received a live vaccine within 3 months of baseline or plans to do so during study.
Patient is a pregnant or breastfeeding (lactating) woman or intending to become pregnant during the study; Women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative result from a serum pregnancy test within 1 week prior to randomization.
+8 more criteria

Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Apremilast

Placebo

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (21)

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Apremilast

Placebo

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (21)

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations