Trial · NCT04300296
PoC Study to Evaluate the Efficacy and Safety of Secukinumab 300 mg in Patients With Lichen Planus
NCT04300296, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2023-08-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PoC Study to Evaluate the Efficacy and Safety of Secukinumab 300 mg in Patients With Lichen Planus. Trials, record NCT04300296. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04300296
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PoC Study to Evaluate the Efficacy and Safety of Secukinumab 300 mg in Patients With Lichen Planus
- NCT number
- NCT04300296
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 111 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Lichen Planus: Cutaneous Lichen Planus, Mucosal Lichen Planus and Lichen Planopilaris
- Interventions
- secukinumab 300 mg Q4W, secukinumab 300 mg Q2W, Placebo
- First posted
- 2020-03-09
- Last updated
- 2023-08-22
- Other registries' IDs
- eudract:2019-003588-24
- Results first posted
- 2023-08-22
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP | 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 | 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) | 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. |
| Secondary | 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) | 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. |
| Secondary | 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) | 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. |
| Secondary | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | 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 |
| Secondary | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | 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. |
| Secondary | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | 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. |
| Secondary | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | 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. |
| Secondary | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | 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". |
| Secondary | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | 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". |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP | Baseline up to week 16 | Full analysis set of participants with a baseline IGA score \>= 3 were included | percentage of participants | MEDIAN |
| SECONDARY | 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) | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32 | Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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) | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32 | Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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) | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32 | Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32 | Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32 | Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32 | Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32 | Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline, Week 16 and Week 32 | Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed. | scores on a scale | MEAN |
| SECONDARY | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Baseline, Week 16 and Week 32 | Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed. | scores on a scale | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group537
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP | AIN457 300 mg Q4W - TP 1 - CLP Cohort | 44.0 | 95% Confidence Interval 25.8 to 63.32 | percentage of participants | |
| Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP | Placebo - TP 1 - CLP Cohort | 58.2 | 95% Confidence Interval 31.0 to 82.6 | percentage of participants | |
| Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP | AIN457 300 mg Q4W - TP 1 - MLP Cohort | 37.5 | 95% Confidence Interval 20.3 to 57.2 | percentage of participants | |
| Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP | Placebo - TP 1 - MLP Cohort | 23.1 | 95% Confidence Interval 6.5 to 49.2 | percentage of participants | |
| Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP | AIN457 300 mg Q4W - TP 1 - LPP Cohort | 37.6 | 95% Confidence Interval 20.2 to 57.3 | percentage of participants | |
| Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP | Placebo - TP 1 - LPP Cohort | 30.9 | 95% Confidence Interval 10.8 to 57.6 | percentage of participants | |
| 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) | AIN457 300 mg Q4W - TP 1 and TP 2 - CLP Cohort | Week 2 IGA <=2 n=25,12,0 | 5 | Participants | |
| 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) | Placebo - TP 1 - CLP Cohort | Week 2 IGA <=2 n=25,12,0 | 1 | Participants | |
| 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) | AIN457 300 mg Q4W - TP 1 and TP 2 - CLP Cohort | Week 2 IGA improvement >=2 n=25,12,0 | 2 | Participants | |
| 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) | Placebo - TP 1 - CLP Cohort | Week 2 IGA improvement >=2 n=25,12,0 | 0 | Participants |
1 to 10 of 537Source ClinicalTrials.gov
See all 537 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1: Baseline to 16 Weeks | STARTED | AIN457 300 mg Q4W - TP 1 and TP 2 - CLP Cohort | 25 | |
| Treatment Period 1: Baseline to 16 Weeks | STARTED | Placebo in TP1 to AIN457 300 mg Q2W - TP 2 - CLP Cohort | 12 | |
| Treatment Period 1: Baseline to 16 Weeks | STARTED | AIN457 300 mg Q4W - TP 1 and TP 2 - MLP Cohort | 24 | |
| Treatment Period 1: Baseline to 16 Weeks | STARTED | Placebo in TP1 to AIN457 300 mg Q2W - TP 2 - MLP Cohort | 13 | |
| Treatment Period 1: Baseline to 16 Weeks | STARTED | AIN457 300 mg Q4W - TP 1 and TP 2 - LPP Cohort | 24 | |
| Treatment Period 1: Baseline to 16 Weeks | STARTED | Placebo in TP1 to AIN457 300 mg Q2W - TP 2 - LPP Cohort | 13 | |
| Treatment Period 1: Baseline to 16 Weeks | Placebo Responder | AIN457 300 mg Q4W - TP 1 and TP 2 - CLP Cohort | 0 | |
| Treatment Period 1: Baseline to 16 Weeks | Placebo Responder | Placebo in TP1 to AIN457 300 mg Q2W - TP 2 - CLP Cohort | 1 | |
| Treatment Period 1: Baseline to 16 Weeks | Placebo Responder | AIN457 300 mg Q4W - TP 1 and TP 2 - MLP Cohort | 0 | |
| Treatment Period 1: Baseline to 16 Weeks | Placebo Responder | Placebo in TP1 to AIN457 300 mg Q2W - TP 2 - MLP Cohort | 1 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events1,008
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymph node pain | Blood and lymphatic system disorders | AIN457 300 mg Q4W - CLP Cohort | 0 | 25 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Placebo - CLP Cohort | 1 | 12 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Any AIN457 300 mg - CLP Cohort | 0 | 33 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Placebo to AIN457 300 mg Q2W - CLP Cohort | 0 | 8 | |
| other | Lymph node pain | Blood and lymphatic system disorders | AIN457 300 mg Q4W - MLP Cohort | 0 | 24 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Placebo - MLP Cohort | 0 | 13 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Any AIN457 300 mg - MLP Cohort | 0 | 35 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Placebo to AIN457 300 mg Q2W - MLP Cohort | 0 | 11 | |
| other | Lymph node pain | Blood and lymphatic system disorders | AIN457 300 mg Q4W - LPP Cohort | 0 | 24 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Placebo - LPP Cohort | 0 | 13 |
1 to 10 of 1,008Source ClinicalTrials.gov
See all 1,008 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AIN457 300 mg Q4W - CLP Cohort | 0 | 25 |
| Total, all-cause mortality | Placebo - CLP Cohort | 0 | 12 |
| Total, all-cause mortality | Any AIN457 300 mg - CLP Cohort | 0 | 33 |
| Total, all-cause mortality | Placebo to AIN457 300 mg Q2W - CLP Cohort | 0 | 8 |
| Total, all-cause mortality | AIN457 300 mg Q4W - MLP Cohort | 0 | 24 |
| Total, all-cause mortality | Placebo - MLP Cohort | 0 | 13 |
| Total, all-cause mortality | Any AIN457 300 mg - MLP Cohort | 0 | 35 |
| Total, all-cause mortality | Placebo to AIN457 300 mg Q2W - MLP Cohort | 0 | 11 |
| Total, all-cause mortality | AIN457 300 mg Q4W - LPP Cohort | 0 | 24 |
| Total, all-cause mortality | Placebo - LPP Cohort | 0 | 13 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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