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Completed

NCT Number: NCT04300296

PoC Study to Evaluate the Efficacy and Safety of Secukinumab 300 mg in Patients With Lichen Planus

The primary purpose of the proof of concept study is to elucidate the efficacy of secukinumab in the treatment of adult patients with biopsy-proven lichen planus not adequately controlled by topical therapies, and to assess the safety and tolerability over 32 weeks.

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Key information

Conditions

Lichen Planus: Cutaneous Lichen Planus, Mucosal Lichen Planus and Lichen Planopilaris Lichen Planus Lichenoid Eruptions Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Bordeaux, France

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About this study

This was a 32-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial which assessed the efficacy and safety of secukinumab 300 mg in two different dosing regimens: every 4 weeks (Q4W) and every 2 weeks (Q2W) in approximately 111 patients with biopsy-proven forms of lichen planus.

There was a screening period (up to 4 weeks prior to baseline), a treatment period 1 (baseline to Week 16), a treatment period 2 (Week 16 to Week 32) and a follow-up period (8 weeks after Week 32).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent must be obtained before any assessment is performed.
  • Female and male patients ≥ 18 years of age.
  • Subjects must have biopsy-confirmed forms of cutaneous lichen planus (CLP), mucosal lichen planus (MLP), or active lichen planopilaris (LPP) eligible for systemic therapy based on the following criteria:
  • rated IGA of ≥ 3 (moderate or severe) AND
  • inadequate response to topical corticosteroids of high-ultrahigh potency in the opinion of the investigator.
  • If using any of the allowed topical treatments on the affected areas, the dose and application frequency should remain stable for 2 weeks prior to randomization and until Week 16.

Exclusion criteria

  • Clinical history suspicious for lichenoid drug eruption.
  • Lichen planus pigmentosus.
  • Clinical picture or history suspicious of paraneoplastic mucosal lichen planus.
  • Subjects whose lichen planus is a predominantly bullous variant.
  • Mucosal LP of the oral cavity or gastrointestinal involvement requiring the patient to use parenteral nutrition or feeding tube.
  • Clinical picture of scarring alopecia without active inflammation.
  • Clinical picture of burnt-out cicatricial alopecia (alopecia of Brocque).
  • Patients diagnosed with frontal fibrosing alopecia (FFA) without active patches of LPP
  • Clinical picture of LPP in patients who have already failed 3 or more systemic immunosuppressive or immunomodulatory agents (e.g. systemic steroids, hydroxychloroquine, cyclosporine, methotrexate and mycophenolate mofetil).
  • Currently enrolled in any other clinical trial involving any investigational agent or device.
  • Previous exposure to any other biologic drug directly targeting IL-17A or IL-17RA (e.g. secukinumab, ixekizumab or brodalumab) or IL-23/p19 (e.g. tildrakizumab, guselkumab, risankizumab).
  • Diagnosis of active infectious diseases of the skin, scalp or mucosa (for example bacterial, viral or fungal infections of the mouth) that may interfere with the assessment of the study disease or require treatment with prohibited medications.
  • Diagnosis of active inflammatory diseases of the skin, scalp or mucosa other than lichen planus that may interfere with the assessment of the study disease or require treatment with prohibited medications.
  • Presence of any other skin condition that may affect the evaluations of the study disease.
  • Underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) and/or presence of laboratory abnormalities which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
  • Current, severe, progressive or uncontrolled diseases that render the patient unsuitable for the trial, including any medical or psychiatric condition that, in the Investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.

Treatment and study plan

secukinumab 300 mg Q4W

Drug

secukinumab 300 mg administered every four weeks (Q4W) via a pre-filled syringe.

Other names: AIN457

secukinumab 300 mg Q2W

Drug

secukinumab 300 mg administered every two weeks (Q2W) via a pre-filled syringe.

Other names: AIN457

Placebo

Other

Matching placebo administered via a pre-filled syringe

Primary outcomes

  1. Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP

    Time frame: Baseline up to week 16

    Number of treatment responders at week 16, where response is defined as an Investigator's Global Assessment (IGA) score of 2 or lower at Week 16. IGA is measured on a scale from 0 - 4 with 0 = Clear, 1 = Minimal; 2 = Mild; 3 = Moderate; and 4 = Severe with 0 being best score and 4 being worst score. CLP=Cutaneous lichen planus, MLP=Mucosal lichen planus, LPP=Lichen planopilaris. Posterior median and 95% credible interval (instead of 95% confidence interval) were derived using Bayesian method based on beta-binomial model.

Secondary outcomes

  1. Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS)

    Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32

    Number of subjects with IGA of 2 or lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score.

  2. Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS)

    Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32

    Number of subjects with IGA of 2 of lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score.

  3. Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS)

    Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32

    Number of subjects with IGA of 2 or lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score.

  4. Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS)

    Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32

    The Physician Assessment of Surface Area of Disease (PSAD) evaluates the extent of cutaneous lesions estimated by investigator or qualified designee. Assessment scores range from 0-5, with lower scores corresponding to lower percentages of surface area with disease: 0=clear, 1=<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=>50% of total body surface

  5. Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS)

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32

    The Dermatology Life Quality Index (DLQI) is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment.

  6. Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS)

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32

    The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts (Finlay and Khan 1994). The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment.

  7. Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS)

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32

    The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts (Finlay and Khan 1994). The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment.

  8. Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS)

    Time frame: Baseline, Week 16 and Week 32

    Itch is assessed with the following questions: • "Overall, how severe was your lichen planus-related itching during the past 24 hours?" • "How severe was your lichen planus-related itching at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related itching during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no itch" and 10 meaning "the worst itch imaginable".

  9. Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS)

    Time frame: Baseline, Week 16 and Week 32

    Itch is assessed with the following questions: • "Overall, how severe was your lichen planus-related itching during the past 24 hours?" • "How severe was your lichen planus-related itching at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related itching during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no itch" and 10 meaning "the worst itch imaginable".

  10. Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS)

    Time frame: Baseline, Week 16 and Week 32

    Itch is assessed with the following questions: • "Overall, how severe was your lichen planus-related itching during the past 24 hours?" • "How severe was your lichen planus-related itching at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related itching during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no itch" and 10 meaning "the worst itch imaginable".

  11. Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS)

    Time frame: Baseline, Week 16 and Week 32

    Pain is assessed with the following questions: • "Overall, how severe was your lichen planus-related pain during the past 24 hours?" • "How severe was your lichen planus-related pain at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related pain during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable".

  12. Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS)

    Time frame: Baseline, Week 16 and Week 32

    Pain is assessed with the following questions: • "Overall, how severe was your lichen planus-related pain during the past 24 hours?" • "How severe was your lichen planus-related pain at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related pain during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable".

  13. Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS)

    Time frame: Baseline, Week 16 and Week 32

    Pain is assessed with the following questions: • "Overall, how severe was your lichen planus-related pain during the past 24 hours?" • "How severe was your lichen planus-related pain at the worst moment during the past 24 hours?" • "Overall, how bothered were you by your lichen planus-related pain during the past 24 hours?" Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable".

  14. Summary of Baseline Score and Change From Baseline in Reticular Erythematous Ulcerative Score (REU) - MLP Cohort - (BOCF) - Entire Treatment Period

    Time frame: Baseline, Week 16 and Week 32

    REU measured disease severity based on 3 dimensions: reticulation, erythema and ulceration for all subjects in the MLP cohort who had an oral presentation of the disease. The total score ranged from 0-115 with higher values corresponding to higher activity of the disease.

  15. Summary of Baseline Score and Change From Baseline in Oral Lichen Planus Symptom Severity Measure (OLPSSM) - MLP Cohort - (BOCF) - Entire Treatment Period

    Time frame: Baseline, Week 16 and Week 32

    OLPSSM is a self-administered assessment of the symptom experience of subjects with oral LP in clinical studies. It includes 7 triggers contributing to soreness of oral lichen planus: Brushing teeth, eating food, drinking liquids, smiling, breathing through mouth, talking and touching. These 7 items contributed equally to a total OLP symptom severity score, ranging from 0 to 28, with higher scores indicating worse severity.

  16. Summary of Baseline Score and Change From Baseline for Lichen Planopilaris Activity Index (LPPAI)- LPP Cohort (BOCF) (FAS)

    Time frame: Baseline, Week 16 and Week 32

    The LPPAI assesses symptoms (pruritus, pain, burning), signs (erythema, perifollicular erythema and scale), a measure of activity (pull test) and extension of disease. These subjective and objective measures are assigned numeric values to establish a disease activity score. The total score ranges from 0 to 10, with higher scores corresponding to higher disease activity

  17. Summary of Baseline Score and Change From Baseline for Scalpdex - LPP Cohort (BOCF) (FAS)

    Time frame: Baseline, Week 16 and Week 32

    Scalpdex is a self-administered, health-related quality of life instrument originally developed for scalp dermatitis. This survey includes 23 items, each item scored on a scale of 0-100, where 0=never, 25=rarely, 50=sometimes, 75=often and 100=all the time. The 23 items pertain to 3 domains: symptom, emotions and functioning. Subjects were asked to score themselves on how true each of the 23 statements has been for them over the past four weeks. the total score is the average of the scores of the 23 items. A higher total score indicated a higher impairment in quality of life.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Proof of Concept Study to Evaluate the Efficacy, Safety and Tolerability of Secukinumab 300 mg Over 32 Weeks in Adult Patients With Biopsy-proven Forms of Lichen Planus Not Adequately Controlled With Topical Therapies - PRELUDE

Acronym: PRELUDE

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Mar 9, 2020
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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