E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10024429 |
E.1.2 | Term | Lichen planus |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of secukinumab when compared to placebo after 16 weeks of treatment, by comparing the proportion of patients achieving Investigator's Global Assessment (IGA) response where IGA response is defined as achivement of absolute IGA score less or equal 2 |
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E.2.2 | Secondary objectives of the trial |
-To evaluate the efficacy of secukinumab 300 mg Q4W compared to placebo throughout 16 weeks in Treatment Period 1 and to evaluate the long term efficacy of secukinumab 300 mg Q4W throughout 32 weeks in Treatment Period 2 and evaluate the efficacy of secukinumab 300 mg Q2W in Treatment Period 2 by Investigator's Global Assessment (IGA), Dermatology Life Quality Index (DLQI), Physician Assessment of Surface Area of Disease (PSAD) for Skin Disease, Patient assessment of itch (NRS), Reticular Erythematous Ulcerative (REU) score, Oral Lichen Planus Symptoms Severity Measure (OLPSSM) score, Patient assessment of pain (NRS), LPP Activity Index (LPPAI), SCALPDEX Questionnaire.
-To assess the safety and tolerability of secukinumab in subjects with lichen planus by Adverse events, laboratory values, vital signs from baseline to end of study visit. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects eligible for inclusion in this study must meet all of the following criteria:
1. Written informed consent must be obtained before any assessment is performed.
2. Female and male patients ≥ 18 years of age.
3. 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
4. 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.
Other protocol-defined inclusion criteria may apply |
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E.4 | Principal exclusion criteria |
Subjects meeting any of the following criteria are not eligible for inclusion in this study.
1. Clinical history suspicious for lichenoid drug eruption.
2. Lichen planus pigmentosus.
3. Clinical picture or history suspicious of paraneoplastic mucosal lichen planus.
4. Subjects whose lichen planus is a predominantly bullous variant.
5. Mucosal LP of the oral cavity or gastrointestinal involvement requiring the patient to use parenteral nutrition or feeding tube.
6. Clinical picture of scarring alopecia without active inflammation.
7. Clinical picture of burnt-out cicatricial alopecia (alopecia of Brocque).
8. Patients diagnosed with frontal fibrosing alopecia (FFA) without active patches of LPP
9. 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).
10. Currently enrolled in any other clinical trial involving any investigational agent or device.
11. 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).
12. 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.
13. 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.
14. Presence of any other skin condition that may affect the evaluations of the study disease.
15. 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.
16. 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.
Other protocol-defined exclusion criteria may apply |
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E.5 End points |
E.5.1 | Primary end point(s) |
Achievement of IGA response |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
All subtypes
1. Achievement of 2 points improvement in the IGA score
2. Achievement of IGA 0/1
3. Absolute and relative change in DLQI
4. Achievement of DLQI 0/1 score
5. Adverse events, laboratory values, vital signs
Cutaneous Lichen Planus (CLP)
6. Absolute and relative change in PSAD
7. Absolute and relative change in NRS
Mucosal Lichen Planus (MLP)
8. Absolute and relative change in REU score
9. Absolute and relative change in OLPSSM score
10. Absolute and relative change in NRS
Lichen Planopilaris (LPP)
11. Absolute and relative change in LPPAI score
12. Absolute and relative change in SCALPDEX Questionnaire score
13. Absolute and relative change in NRS (pain)
14. Absolute and relative change in NRS (itch) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. from baseline to week 16 and 32, and throughout the duration of the study
2. at week 16 and 32, and throughout the duration of the study
3. from baseline to week 16 and 32, and throughout the duration of the study
4. at week 16 and 32, and throughout the duration of the study
5. throughout the duration of the study
6 to 14. from baseline to week 16 and 32, and throughout the duration of the study
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 6 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 21 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
France |
Germany |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 2 |
E.8.9.2 | In all countries concerned by the trial years | 2 |