The AP-GELP Study: A Clinical Trial on the Effects of Apremilast in Female Genital Erosive Lichen Planus

NCT ID: NCT03656666

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-24
• Study Completion Date: 2023-12-31

Brief Summary

Genital erosive lichen planus (GELP) is a chronic inflammatory disease causing painful genital sores and scarring in women. Treatment options are limited and often unsatisfactory. This trial will study the effects of treatment with apremilast and quality of life and sexual function in women with GELP.

Detailed Description

Genital erosive lichen planus (GELP) is a chronic, inflammatory and scarring genital disease. The disease may have a significant impact on daily living, quality of life and sexual function. There is a considerable lack of high-quality evidence on treatment options for GELP and few effective therapeutic facilities available in current clinical practice.

The aims of this study are to investigate clinical and immunohistochemical effects of a new oral anti-inflammatory treatment, apremilast, for women with moderate-to-severe GELP in a double-blinded, randomized, placebo-controlled trial (RCT). Apremilast is an inhibitor of phosphodiesterase 4 (PDE4) with documented effect in several inflammatory skin diseases, but it has not yet been studied in patients with GELP. The drug dose and study design have been chosen based on relevant experience from other studies on apremilast, and is equivalent to the dose used for approved indications (chronic plaque psoriasis and psoriatic arthritis).

The main objective of this trial is to assess the efficacy of apremilast in the treatment of GELP in women.

Secondary objectives include

• Description of immunohistochemical changes in lichen planus lesions
• Assessment of safety of apremilast in the treatment of GELP
• Assessment of quality of life and sexual function

Conditions

Lichen Planus of Vulva; Female Genital Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Apremilast

Week 0-24: 21 patients will receive apremilast oral tablets with initial standard titration of dose day 1-6 followed by standard dose of 30 mg apremilast b.i.d.

Initial titration:

Day 1: 10 mg in morning. Day 2: 10 mg in morning and 10 mg in evening. Day 3: 10 mg in morning and 20 mg in evening. Day 4: 20 mg in morning and 20 mg in evening. Day 5: 20 mg in morning and 30 mg in evening. Day 6 and thereafter: 30 mg twice daily.

Group Type: ACTIVE_COMPARATOR

Apremilast

Intervention Type: DRUG

Apremilast oral tablets

Placebo + Apremilast

Week 0-24: 21 patients will receive matching placebo oral tablets, with initial titration.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo oral tablets

Interventions

Apremilast

Apremilast oral tablets

Intervention Type: DRUG

Placebo

Placebo oral tablets

Intervention Type: DRUG

Other Intervention Names

Otezla; Placebo (for apremilast)

Eligibility Criteria

Inclusion Criteria

• Moderate to severe GELP at inclusion with the diagnosis based on characteristic clinical and/or histological features. Minimum GELP score 5/30 in vagina and/or vulva (scored separately), of which erythema and pain ≥1 are mandatory
• Informed consent from the patient to the protocol and clinical procedures.

Exclusion Criteria

• Patients receiving other systemic immune modulating therapy
• Concomitant use of strong CYP3A4 enzyme inducers
• Inadequate birth control, pregnancy and/or breast-feeding
• Depression and suicidal ideation
• Patients with severe renal impairment
• Patients with active tuberculosis, serious infections or cancer
• Unexplained and clinically significant weight loss in underweight patients
• Hypersensitivity to the active substance(s) or to any of the excipients
• Hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
• Participating in another trial that might affect the current study or there should be minimum 90 days between participation in another intervention trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Amgen

INDUSTRY

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anne Lise Helgesen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Lise Helgesen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital HF

Locations

Oslo University Hospital HF

Oslo, , Norway

Countries

Norway

Other Identifiers

AP-GELP

Identifier Type: -

Identifier Source: org_study_id