Lichen Planus: Cutaneous Lichen Planus, Mucosal Lichen Planus and Lichen PlanopilarisPhase 2PRELUDENCT04300296

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

A Phase 2 study testing secukinumab 300 mg Q4W and secukinumab 300 mg Q2W in people with Lichen Planus: Cutaneous Lichen Planus, Mucosal Lichen Planus and Lichen Planopilaris, run by Novartis Pharmaceuticals at 35 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lichen Planus: Cutaneous Lichen Planus, Mucosal Lichen Planus and Lichen Planopilaris
What is being tested?: secukinumab 300 mg Q4W and secukinumab 300 mg Q2W
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 111 participants
Where: 35 sitesin 3 countries
Study dates: 27 Jul 2020to 3 May 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 16Show fewer

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.

Trial locations and contacts

35 sites in 3 countries.

Country

City, postcode or hospital

35 sites in 3 countries

United States15 sites

Novartis Investigative Site
Birmingham, Alabama, 35233
Novartis Investigative Site
Charleston, South Carolina, 29407
Novartis Investigative Site
Cromwell, Connecticut, 06416
Novartis Investigative Site
East Windsor, New Jersey, 08520
Novartis Investigative Site
Forest Hills, New York, 11375
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Jacksonville, Florida, 32224
Novartis Investigative Site
Las Vegas, Nevada, 89128
Novartis Investigative Site
Miami, Florida, 33125
Novartis Investigative Site
New York, New York, 10025 1737
Novartis Investigative Site
Omaha, Nebraska, 68144
Novartis Investigative Site
Pflugerville, Texas, 78660
Novartis Investigative Site
Portland, Oregon, 97223
Novartis Investigative Site
Snellville, Georgia, 30078
Novartis Investigative Site
Thousand Oaks, California, 91320

Other trials in United States

Germany11 sites

Novartis Investigative Site
Aachen, 52074
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Bramsche, 49565
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Halle, 06120
Novartis Investigative Site
Hamburg, 20354
Novartis Investigative Site
Lübeck, 23538
Novartis Investigative Site
Marburg, 35039
Novartis Investigative Site
München, 81377
Novartis Investigative Site
Würzburg, 97080

Other trials in Germany

France9 sites

Novartis Investigative Site
Bordeaux, 33075
Novartis Investigative Site
Chambray-lès-Tours, 37170
Novartis Investigative Site
Lyon, 69437
Novartis Investigative Site
Marseille, 13885
Novartis Investigative Site
Nantes, 44093
Novartis Investigative Site
Nice, 06202
Novartis Investigative Site
Paris, 75475
Novartis Investigative Site
Rouen, 76031
Novartis Investigative Site
Toulouse, 31400

Other trials in France

About this study

Official 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

Read the detailed description

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).

Conditions: Lichen Planus: Cutaneous Lichen Planus, Mucosal Lichen Planus and Lichen Planopilaris
Being tested: secukinumab 300 mg Q4W, secukinumab 300 mg Q2W, Placebo
Keywords: Lichen planus, CLP, MLP, LPP
Medical subject headings: Lichen Planus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

secukinumab 300 mg Q4WDrug
Also called AIN457
secukinumab 300 mg administered every four weeks (Q4W) via a pre-filled syringe.
secukinumab 300 mg Q2WDrug
Also called AIN457
secukinumab 300 mg administered every two weeks (Q2W) via a pre-filled syringe.
PlaceboOther
Matching placebo administered via a pre-filled syringe

Study groups in NCT04300296
Study group	Role	What they receive
Cutaneous lichen planus secukinumab 300mg Q4W	Experimental	Secukinumab 300 mg every 4 weeks provided in pre-filled syringe in cutaneous lichen planus patients Receives: Drug: secukinumab 300 mg Q4W
Cutaneous lichen planus placebo	Placebo comparator	Placebo in 1ml PFS in cutaneous lichen patients Receives: Other: Placebo
Mucosal lichen planus secukinumab 300 mg Q4W	Experimental	Secukinumab 300 mg every 4 weeks provided in pre-filled syringe in mucosal lichen planus patients. Receives: Drug: secukinumab 300 mg Q4W
Mucosal lichen planus placebo	Placebo comparator	Placebo 1 ml PFS in mucosal lichen planus patients Receives: Other: Placebo
Lichen planopilaris secukinumab 300 mg Q4W	Experimental	Secukinumab 300 mg every 4weeks provided in pre-filled syringe in lichen planopilaris patients. Receives: Drug: secukinumab 300 mg Q4W
Lichen planopilaris placebo	Placebo comparator	Placebo in 1ml PFS in lichen planopilaris patients Receives: Other: Placebo
Cutaneous lichen planus placebo to secukinumab 300 mg Q2W	Experimental	Non responder patients on placebo in TP 1 received secukinumab 300 mg Q2W in TP 2 Receives: Drug: secukinumab 300 mg Q2W
Mucosal lichen planus placebo to secukinumab 300 mg Q2W	Experimental	Non responder patients on placebo in TP 1 received secukinumab 300 mg Q2W in TP 2 Receives: Drug: secukinumab 300 mg Q2W
Lichen planopilaris placebo to secukinumab 300 mg Q2W	Experimental	Non responder patients on placebo in TP 1 received secukinumab 300 mg Q2W in TP 2 Receives: Drug: secukinumab 300 mg Q2W

What is being measured

The primary outcome is the main question the study is designed to answer.

Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP
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.
Measured: Baseline up to week 16

Secondary outcomes (17)

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)
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.
Measured: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
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)
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.
Measured: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
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)
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.
Measured: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS)
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
Measured: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS)
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.
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS)
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.
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS)
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.
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS)
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".
Measured: Baseline, Week 16 and Week 32
Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS)
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".
Measured: Baseline, Week 16 and Week 32
Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS)
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".
Measured: Baseline, Week 16 and Week 32
Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS)
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".
Measured: Baseline, Week 16 and Week 32
Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS)
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".
Measured: Baseline, Week 16 and Week 32
Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS)
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".
Measured: Baseline, Week 16 and Week 32
Summary of Baseline Score and Change From Baseline in Reticular Erythematous Ulcerative Score (REU) - MLP Cohort - (BOCF) - Entire Treatment Period
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.
Measured: Baseline, Week 16 and Week 32
Summary of Baseline Score and Change From Baseline in Oral Lichen Planus Symptom Severity Measure (OLPSSM) - MLP Cohort - (BOCF) - Entire Treatment Period
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.
Measured: Baseline, Week 16 and Week 32
Summary of Baseline Score and Change From Baseline for Lichen Planopilaris Activity Index (LPPAI)- LPP Cohort (BOCF) (FAS)
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
Measured: Baseline, Week 16 and Week 32
Summary of Baseline Score and Change From Baseline for Scalpdex - LPP Cohort (BOCF) (FAS)
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.
Measured: Baseline, Week 16 and Week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jul 20203 May 2022

First posted9 Mar 2020
Study start27 Jul 2020
Primary completion16 Nov 2021
Study completion3 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Lichen Planus: Cutaneous Lichen Planus, Mucosal Lichen Planus and Lichen PlanopilarisStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: PoC study, 32-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial assessing the efficacy and safety of secukinumab 300 mg in two different dosing regimens in 108 patients with biopsy-proven forms of lichen planus.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04300296
Sponsor's protocol ID: CAIN457S12201
Other IDs: 2019-003588-24, 2019
Acronym: PRELUDE
Status last verified: Jul 2023
First submitted: 8 Jan 2020
Last updated: 22 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

Mahon-Smith A, Skingley G, Ayala-Nunes L, Batish A, Sharp R, Naujoks C, Schruf E, Compagno N, Moreno SG. Evaluating the Appropriateness of Existing Health-Related Quality of Life Measures in Lichen Planus. Dermatol Ther (Heidelb). 2023 Nov;13(11):2817-2837. doi: 10.1007/s13555-023-00990-4. Epub 2023 Oct 5.
PubMed 37794275
Mahon-Smith A, Clifford M, Batish A, Sharp R, Panter C, Naujoks C, Schruf E, Compagno N, Moreno SG. Patient Experience of Lichen Planus: A Qualitative Exploration of Signs, Symptoms, and Health-Related Quality of Life Impacts. Dermatol Ther (Heidelb). 2023 Sep;13(9):2001-2017. doi: 10.1007/s13555-023-00968-2. Epub 2023 Jul 28.
PubMed 37505393
Miteva M, Nadji M, Billero V, LaSenna C, Nattkemper L, Romanelli P. IL-17 Expression in the Perifollicular Fibrosis in Biopsies From Lichen Planopilaris. Am J Dermatopathol. 2022 Dec 1;44(12):874-878. doi: 10.1097/DAD.0000000000002316. Epub 2022 Sep 27.
PubMed 36197049

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT04300296
Acronym / sponsor ID: PRELUDE / CAIN457S12201
Conditions: Lichen Planus: Cutaneous Lichen Planus, Mucosal Lichen Planus and Lichen Planopilaris
Keywords: Lichen planus, CLP, MLP, LPP
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 111 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 27 Jul 2020 (actual)
Primary completion: 16 Nov 2021 (actual)
Study completion: 3 May 2022 (actual)
First posted: 9 Mar 2020 (actual)
Results: Posted 22 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 9
Model description: PoC study, 32-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial assessing the efficacy and safety of secukinumab 300 mg in two different dosing regimens in 108 patients with biopsy-proven forms of lichen planus.

Arm	Type	Receives
Cutaneous lichen planus secukinumab 300mg Q4W	Experimental	Drug: secukinumab 300 mg Q4WSecukinumab 300 mg every 4 weeks provided in pre-filled syringe in cutaneous lichen planus patients
Cutaneous lichen planus placebo	Placebo comparator	Other: PlaceboPlacebo in 1ml PFS in cutaneous lichen patients
Mucosal lichen planus secukinumab 300 mg Q4W	Experimental	Drug: secukinumab 300 mg Q4WSecukinumab 300 mg every 4 weeks provided in pre-filled syringe in mucosal lichen planus patients.
Mucosal lichen planus placebo	Placebo comparator	Other: PlaceboPlacebo 1 ml PFS in mucosal lichen planus patients
Lichen planopilaris secukinumab 300 mg Q4W	Experimental	Drug: secukinumab 300 mg Q4WSecukinumab 300 mg every 4weeks provided in pre-filled syringe in lichen planopilaris patients.
Lichen planopilaris placebo	Placebo comparator	Other: PlaceboPlacebo in 1ml PFS in lichen planopilaris patients
Cutaneous lichen planus placebo to secukinumab 300 mg Q2W	Experimental	Drug: secukinumab 300 mg Q2WNon responder patients on placebo in TP 1 received secukinumab 300 mg Q2W in TP 2
Mucosal lichen planus placebo to secukinumab 300 mg Q2W	Experimental	Drug: secukinumab 300 mg Q2WNon responder patients on placebo in TP 1 received secukinumab 300 mg Q2W in TP 2
Lichen planopilaris placebo to secukinumab 300 mg Q2W	Experimental	Drug: secukinumab 300 mg Q2WNon responder patients on placebo in TP 1 received secukinumab 300 mg Q2W in TP 2

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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:
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.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
secukinumab 300 mg Q4WAlso: AIN457secukinumab 300 mg administered every four weeks (Q4W) via a pre-filled syringe.	Drug	Cutaneous lichen planus secukinumab 300mg Q4W, Lichen planopilaris secukinumab 300 mg Q4W, Mucosal lichen planus secukinumab 300 mg Q4W
secukinumab 300 mg Q2WAlso: AIN457secukinumab 300 mg administered every two weeks (Q2W) via a pre-filled syringe.	Drug	Cutaneous lichen planus placebo to secukinumab 300 mg Q2W, Lichen planopilaris placebo to secukinumab 300 mg Q2W, Mucosal lichen planus placebo to secukinumab 300 mg Q2W
PlaceboMatching placebo administered via a pre-filled syringe	Other	Cutaneous lichen planus placebo, Lichen planopilaris placebo, Mucosal lichen planus placebo

Primary outcome

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.

17 secondary outcomes

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 ≤ 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 ≤ 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 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
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
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
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
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
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
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
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
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
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
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
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
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
Summary of Baseline Score and Change From Baseline for Scalpdex - LPP Cohort (BOCF) (FAS)
Time frame: Baseline, Week 16 and Week 32

Results and safety

Results posted to the registry on 22 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AIN457 300 mg Q4W - TP 1 and TP 2 - CLP Cohort	25	23
Placebo in TP1 to AIN457 300 mg Q2W - TP 2 - CLP Cohort	12	10
AIN457 300 mg Q4W - TP 1 and TP 2 - MLP Cohort	24	24
Placebo in TP1 to AIN457 300 mg Q2W - TP 2 - MLP Cohort	13	13
AIN457 300 mg Q4W - TP 1 and TP 2 - LPP Cohort	24	23
Placebo in TP1 to AIN457 300 mg Q2W - TP 2 - LPP Cohort	13	12

Primary outcome: 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. Median (95% Confidence Interval). Unit: percentage of participants

Measure	AIN457 300 mg Q4W - TP 1 - CLP Cohort n = 25	Placebo - TP 1 - CLP Cohort n = 12	AIN457 300 mg Q4W - TP 1 - MLP Cohort n = 24	Placebo - TP 1 - MLP Cohort n = 13	AIN457 300 mg Q4W - TP 1 - LPP Cohort n = 24	Placebo - TP 1 - LPP Cohort n = 13
Value	44.0 (25.8 to 63.32)	58.2 (31.0 to 82.6)	37.5 (20.3 to 57.2)	23.1 (6.5 to 49.2)	37.6 (20.2 to 57.3)	30.9 (10.8 to 57.6)

AIN457 300 mg Q4W - TP 1 - CLP Cohort vs Placebo - TP 1 - CLP Cohort: Posterior median difference: -13.9 (95% CI -44.8 to 19.3)
AIN457 300 mg Q4W - TP 1 - MLP Cohort vs Placebo - TP 1 - MLP Cohort: Posterior median difference: 14.1 (95% CI -17.0 to 40.7)
AIN457 300 mg Q4W - TP 1 - LPP Cohort vs Placebo - TP 1 - LPP Cohort: Posterior median difference: 6.5 (95% CI -25.4 to 35.4)

Population analysed: Full analysis set of participants with a baseline IGA score \>= 3 were included

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were reported from first dose of study treatment up to a maximum of 300 days which included an approximate follow up period of 8 weeks for AIN457 treatment groups.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AIN457 300 mg Q4W - CLP Cohort	0 of 25 (0%)	15 of 25 (60%)	0 of 25
Placebo - CLP Cohort	1 of 12 (8.3%)	7 of 12 (58.3%)	0 of 12
Any AIN457 300 mg - CLP Cohort	0 of 33 (0%)	21 of 33 (63.6%)	0 of 33
Placebo to AIN457 300 mg Q2W - CLP Cohort	0 of 8 (0%)	6 of 8 (75%)	0 of 8
AIN457 300 mg Q4W - MLP Cohort	1 of 24 (4.2%)	18 of 24 (75%)	0 of 24
Placebo - MLP Cohort	0 of 13 (0%)	8 of 13 (61.5%)	0 of 13
Any AIN457 300 mg - MLP Cohort	2 of 35 (5.7%)	26 of 35 (74.3%)	0 of 35
Placebo to AIN457 300 mg Q2W - MLP Cohort	1 of 11 (9.1%)	8 of 11 (72.7%)	0 of 11
AIN457 300 mg Q4W - LPP Cohort	0 of 24 (0%)	16 of 24 (66.7%)	0 of 24
Placebo - LPP Cohort	1 of 13 (7.7%)	7 of 13 (53.8%)	0 of 13
Any AIN457 300 mg - LPP Cohort	1 of 36 (2.8%)	22 of 36 (61.1%)	0 of 36
Placebo to AIN457 300 mg Q2W - LPP Cohort	1 of 12 (8.3%)	6 of 12 (50%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37794275Mahon-Smith A, Skingley G, Ayala-Nunes L, Batish A, Sharp R, Naujoks C, Schruf E, Compagno N, Moreno SG. Evaluating the Appropriateness of Existing Health-Related Quality of Life Measures in Lichen Planus. Dermatol Ther (Heidelb). 2023 Nov;13(11):2817-2837. doi: 10.1007/s13555-023-00990-4. Epub 2023 Oct 5.
Derived from this study: PubMed 37505393Mahon-Smith A, Clifford M, Batish A, Sharp R, Panter C, Naujoks C, Schruf E, Compagno N, Moreno SG. Patient Experience of Lichen Planus: A Qualitative Exploration of Signs, Symptoms, and Health-Related Quality of Life Impacts. Dermatol Ther (Heidelb). 2023 Sep;13(9):2001-2017. doi: 10.1007/s13555-023-00968-2. Epub 2023 Jul 28.
Derived from this study: PubMed 36197049Miteva M, Nadji M, Billero V, LaSenna C, Nattkemper L, Romanelli P. IL-17 Expression in the Perifollicular Fibrosis in Biopsies From Lichen Planopilaris. Am J Dermatopathol. 2022 Dec 1;44(12):874-878. doi: 10.1097/DAD.0000000000002316. Epub 2022 Sep 27.
Individual participant dataSharing planned: Yes. Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

35 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Germany, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04300296, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.