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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04528082
Other study ID # 20190530
Secondary ID 2019-002787-27
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 9, 2021
Est. completion date July 1, 2028

Study information

Verified date December 2023
Source Amgen
Contact Amgen Call Center
Phone 866-572-6436
Email medinfo@amgen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to estimate the efficacy of apremilast compared to placebo in the treatment of oral ulcers in pediatric participants from 2 to < 18 years of age with oral ulcers associated with Behçet's disease (BD) through week 12.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date July 1, 2028
Est. primary completion date August 23, 2027
Accepts healthy volunteers No
Gender All
Age group 2 Years to 17 Years
Eligibility Key Inclusion Criteria - Male or Female participants 2 to < 18 years of age at randomization. - Diagnosed with behçet's disease (BD) meeting the International Study Group for Behçet Disease (ISGBD) criteria at any time prior to the screening visit. - Oral ulcers that occurred = 3 times within the 12-month period prior to the screening visit. - Participant must have = 2 oral ulcers at both the screening visit and on day 1. - Participant has had prior treatment with = 1 non-biologic BD therapy, such as, but not limited to, topical corticosteroids or systemic treatment. Key Exclusion Criteria - Behcet's disease-related active major organ involvement - pulmonary (eg, pulmonary artery aneurysm), vascular (eg, thrombophlebitis), gastrointestinal (eg, ulcers along the gastrointestinal tract), and central nervous system (CNS) (eg, meningoencephalitis) manifestations, and ocular lesions (eg, uveitis) requiring immunosuppressive therapy; however: - Previous major organ involvement is allowed if it occurred =1 year prior to the screening visit and is not active at time of enrollment - Participants with mild BD-related ocular lesions not requiring systemic immunosuppressive therapy are allowed - Participants with BD-related arthritis and BD-skin manifestations are also allowed. - Previous exposure to biologic therapies for the treatment of BD oral ulcers, previous biologic exposure is allowed for other indications (including other manifestations of BD).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Apremilast
Participants will receive apremilast orally.
Placebo
Participants will receive the matching placebo orally.

Locations

Country Name City State
France Hospices Civils de Lyon Hopital Femme Mere Enfant Bron cedex
France Hopital Necker Enfants Malades Paris
France Hopital Robert Debre Paris
Greece Agia Sofia Children Hospital Athens
Greece Attikon University General Hospital Athens
Greece General Hospital of Thessaloniki Ippokrateio Thessaloniki
Israel Meir Medical Center Kfar Saba
Italy Ospedale Santissima Annunziata Chieti
Italy IRCCS Istituto Giannina Gaslini Genova
Italy Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini Milano
Italy IRCCS Ospedale Pediatrico Bambino Gesu Roma
Spain Hospital Universitari Vall d Hebron Barcelona Cataluña
Spain Hospital Sant Joan de Deu Esplugues de Llobregat Cataluña
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Ramon y Cajal Madrid
Spain Hospital Universitario Virgen del Rocio Sevilla Andalucía
Spain Hospital Universitari i Politecnic La Fe Valencia Comunidad Valenciana
Switzerland Centre Hospitalier Universitaire Vaudois Lausanne
Turkey Hacettepe Universitesi Tip Fakultesi Hastanesi Ankara
Turkey Istanbul Universitesi Cerrahpasa Tip Fakultesi Istanbul
Turkey Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi Istanbul
Turkey Umraniye Egitim ve Arastirma Hastanesi Istanbul
Turkey Dokuz Eylul Universitesi Tip Fakultesi Hastanesi Izmir
Turkey Erciyes Universitesi Tip Fakultesi Hastanesi Kayseri
United Kingdom Birmingham Childrens Hospital Birmingham
United Kingdom Alder Hey Childrens Hospital Liverpool

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

France,  Greece,  Israel,  Italy,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area Under the Curve for the Number of Oral Ulcers from Week 0 Through Week 12 (AUCw0-12) Week 0 to Week 12
Secondary Number of Oral Ulcers from Week 0 to Week 12 Week 0 to Week 12
Secondary Change from Week 0 to Week 12 in the Pain of Oral Ulcers Pain of oral ulcers will be measured by a visual analog scale (VAS). The participants will be asked to place a vertical line on a 100 mm VAS at the point that represents the severity of oral ulcer pain. The scale will range from "no pain" (left hand boundary) to "worst possible pain" (right hand boundary). Week 0 to Week 12
Secondary Complete Response Rate for Oral Ulcers Complete response rate for oral ulcers is defined as the proportion of participants who are oral ulcer free at Week 12. Week 12
Secondary Proportion of Participants at Week 12 Whose Number of Oral Ulcers is Reduced by Greater Than or Equal to 50% from Week 0 Week 0 to Week 12
Secondary Complete Response Rate for Genital Ulcers Complete response rate for genital ulcers is defined as the proportion of participants (with genital ulcers at week 0) who are genital ulcer free at Week 12. Week 12
Secondary Change from Week 0 to Week 12 in Disease Activity Disease activity is measured by Behçet's Disease Current Activity (BDCAF) scores. The BDCAF consists of 3 component scores: the Behçet's Disease Current Activity Index (BDCAI) score, the Patient's Perception of Disease Activity, and the Clinician's Overall Perception of Disease Activity. The BDCAI score ranges from 0 to 12. A higher score indicates higher level of disease activity (worsening), and a negative change from baseline indicates improvement. The Patient's Perception of Disease Activity and the Clinician's Overall Perception of Disease Activity were assessed by the subject and the clinician, respectively, using a scale of 1 to 7, where a higher score indicates a higher level of disease activity. Week 0 to Week 12
Secondary Proportion of Participants at Week 12 Who Have New-onset or Recurrence of Behçet's-related Manifestations (Other than Oral and Genital Ulcers) Week 12
Secondary Change from Week 0 to Week 12 on the Short Form Survey (SF-10) The SF-10 Health Survey for Children is a parent-completed survey that contains 10 questions adapted from the Child Health Questionnaire. The SF-10 is intended to produce physical and psychosocial health summary measures. Each of the 10 questions responses is scored with a point value from 1 to 6 (1 is the worst possible condition and 6 is the best possible condition). The SF-10 physical and psychosocial measures are scored such that higher scores indicate more favorable functioning. Week 0 to Week 12
Secondary Number of Participants with a Treatment-emergent Adverse Event Up to Week 56
Secondary Occurrence, Severity, and Frequency of Suicide/Suicide-related Ideations and Behaviors as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Number of participants with suicidal ideation or behavior is defined as the number of participants who answer "yes" at any time during the study (up to end of safety follow-up, Week 56) to one of the 10 categories:
Category 1: Wish to be dead Category 2: Non-specific active suicidal thoughts Category 3: Active suicidal ideation with any methods (not plan) without intent to act Category 4: Active suicidal ideation with some intent to act, without specific plan Category 5: Active suicidal ideation with specific plan and intent Category 6: Preparatory acts or behavior Category 7: Aborted attempt Category 8: Interrupted attempt Category 9: Actual attempt (non-fatal) Category 10: Completed suicide
Up to Week 56
Secondary Change from Week 0 to Week 52 in Tanner Staging Tanner Staging of sexual development assessment will be used to assess sexual maturity. Tanner Staging assessment consists of 3 domains (pubic hair, breast development, and other changes) for girls and 4 domains (pubic hair, penis development, testes development, and other changes) for boys. Stages range from 1-5, with 1 indicating preadolescent and 5 adult. Week 0 to Week 52
Secondary Change in Body Weight Measurements Week 0 to Week 56
Secondary Change in Height Measurements Week 0 to Week 56
Secondary Change in Body Mass Index (BMI) BMI assessed as weight/(height/100)^2 Week 0 to Week 56
Secondary Plasma Concentrations of Apremilast Up to Week 52
Secondary Taste and Acceptability of Apremilast Taste and acceptability will be assessed using a questionnaire with a 7-point faces Likert Scale, with 1 ranging from "super bad" to 7 "super good" and questions to determine whether the participants are able to take the treatment medication. Week 0 and Week 2
Secondary Proportion of Participants Who Require Protocol-prohibited Medications due to Worsening of Behçet's Disease Week 0 to Week 12
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