Trial Evaluating the Efficacy of Apremilast for the Treatment of Frontal Fibrosing Alopecia

NCT03422640 | Unknown Phase 4 FDA Drug

• 1 other identifier: BD1-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is open label single side study involvement 20 patient treated with Apremilast. Each enrolled patient may be evaluated at by a dermatologist using the Lichen Planopilaris Activity Index and Frontal Fibrosing Alopecia Index. Other measures include physician global assessment, dermatology quality of life and patients analogue score for pruritus. Pt will have visits at Week 0,2,4,8,12,16,20,24

Conditions

Frontal Fibrosing Alopecia

Keywords

Frontal Fibrosing Alopecia; Apremilast

Outcome Measures

Primary Outcomes (1)

• Lichen Planopilaris index

  The weights given to the symptoms (30%), signs (30%), anagen pull test (25%), and presence of spreading (15%) led to the equation: LPPAI (0-10) = (pruritus + pain + burning)/3 + (scalp erythema + perifollicular erythema + perifollicular scale)/3 + 2.5 (pull test) + 1.5 (spreading/2). Symptoms and signs are recorded on a 4-point scale. The anagen pull test involves grasping a small group of 10 to 20 hairs between the thumb, second finger, and third finger at the scalp end of the hair shafts, and pulling away from the scalp with a slow, firm perpendicular force to slide the fingers to the ends of the hair. The result is recorded both as a binary value (0 for no anagen hairs and 1 for the presence of anagen hairs) and as anagen hairs/total hairs pulled. Last is the assessment of spreading, recorded as 0 (no spreading) versus 1 (indeterminate) versus 2 (spreading). Our primary endpoint is percentage change from baseline

  Week 0 to 24, patient visit week0,2,4,8,12,16,20,24

Secondary Outcomes (4)

• Physicians global assessment

  Weeks 0 to 24, patient visit week 0,2,4,8,12,16,20,24

• Visual Analogue Scale Pruritus

  Weeks 0 to 24, patient visit week 0,2,4,8,12,16,20,24

• Frontal Fibrosing Alopecia Index

  Weeks 0 to 24, patient visit weeks 0,2,4,8,12,16,20,24

• Dermatology Quality of Life (DLQI) (Appendix E) Dermatology Quality of Life (DLQI) (Appendix E) Dermatology Quality of Life (DLQI)

  Weeks 0 to 24, patient visit weeks 0,2,4,8,12,16,20,24

Study Arms (1)

Treatment arm with apremilast

EXPERIMENTAL

Open label arm treating frontal fibrosing alopecia with apremilast

Drug: Apremilast

Interventions

Apremilast DRUG

Open label treatment with apremilast

Also known as: Otezla

Treatment arm with apremilast

Eligibility Criteria

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

You may qualify if:

• Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
• Male or Female and is at least 18 years of age, at the time of enrollment.
• 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; 3. 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. 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 nonlatex 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.
• † A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) consecutive months (that is, has had menses at any time during the preceding 24 consecutive months).
• § 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).
• Patients with an established diagnosis of FFA based on the enrolling investigator's clinical judgment
• Patients who have been treated and failed one standard therapy including
• Topical steroids
• Short course systemic steroids
• Systemic antibiotics
• Patients who are on stable dose of topical steroids or systemic antibiotics
• Patient and/or legal guardian has voluntarily signed and dated an informed consent/patient authorization form approved by an Institutional Review Board (IRB)/Ethics Committee (EC) if applicable according to local law, after the nature of the study has been explained and the patient has had the opportunity to ask questions.

You may not qualify if:

• 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.
• Pregnant or breast feeding.
• Active substance abuse or a history of substance abuse within 6 months prior to Screening.
• 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.
• Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
• Prior treatment with apremilast.
• Patient who have underlying chronic infections including HIV, Hep B and C.
• History of uncontrolled depression.

Sponsors & Collaborators

• Bellevue Dermatology: lead
• Celgene: collaborator

Study Sites (1)

Bellevue Dermatology

Bellevue, Washington, 98004, United States

RECRUITING

MeSH Terms

Interventions

apremilast

Study Officials

• Clive Liu, MD

  Bellevue Dermatology

  STUDY DIRECTOR

Central Study Contacts

Clive M Liu, MD

CONTACT

425-455-2275; Cliveliumd@gmail.com

Ivy T Chan, BA

CONTACT

510-332-4783; Gcpchan@aol.com

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: Director

Model Details: This is open label single side study involvement 20 patient treated with Apremilast. Each enrolled patient may be evaluated at by a dermatologist using the Lichen Planopilaris Activity Index and Frontal Fibrosing Alopecia Index. Other measures include physician global assessment, dermatology quality of life and patients analogue score for pruritus. Pt will have visits at Week 0,2,4,8,12,16,20,24

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 6, 2018
• Study Start: July 12, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: July 16, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)