NCT03656666

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 24, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

3.2 years

First QC Date

August 15, 2018

Last Update Submit

March 28, 2023

Conditions

Lichen Planus of VulvaFemale Genital Disease

Keywords

apremilastgenital erosive lichen planus

Outcome Measures

Primary Outcomes (1)

  • Mean GELP score at week 24 in apremilast-treated patients versus placebo-treated patients

    The GELP (Genital Erosive Lichen Planus) score is a scoring system for clinical assessment of genital erosive lichen planus (GELP) in women. Area of genital involvement, erythema, striae, number of erosions and pain are registered and scored 0-3 (0 is none) for each parameter. Vulval and vaginal involvement is assessed separately, resulting in a maximum GELP score of 30.

    24 weeks

Secondary Outcomes (14)

  • Mean GELP score improvement from week 0 to week 24 in all patients

    24 weeks

  • Weekly use of topical steroid, collected from patient diary

    24 weeks

  • Weekly VAS pain score, collected from patient diary

    24 weeks

  • Number of patients with GELP score improvement at week 16 and 24

    24 weeks

  • Separate GELP score assessments: Area of involvement (in cm²)

    24 weeks

  • +9 more secondary outcomes

Other Outcomes (4)

  • Description of immune histochemical changes and expression of selected cytokines before and after apremilast therapy, assessed in vulvar or vaginal biopsies

    24 weeks

  • Description of extragenital lichen planus at week 0, 16 and 24

    24 weeks

  • Evaluation of clinical photos

    24 weeks

  • +1 more other outcomes

Study Arms (2)

Apremilast

ACTIVE COMPARATOR

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.

Drug: Apremilast

Placebo + Apremilast

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

ApremilastDRUG

Apremilast oral tablets

Also known as: Otezla
Apremilast
PlaceboDRUG

Placebo oral tablets

Also known as: Placebo (for apremilast)
Placebo + Apremilast

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent from the patient to the protocol and clinical procedures.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital HF

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

apremilast

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Anne Lise Helgesen, MD PhD

    Oslo University Hospital HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-blinded, randomized, placebo-controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 15, 2018

First Posted

September 4, 2018

Study Start

September 24, 2019

Primary Completion

November 30, 2022

Study Completion

December 31, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

NO(1)