Trial · NCT03331835
A Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis
NCT03331835, Phase 4, Completed, LEO Pharma; results first posted 2020-02-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis. Trials, record NCT03331835. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03331835
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis
- NCT number
- NCT03331835
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 210 participants, actual
- Lead sponsor
- LEO Pharma
- Conditions
- Psoriasis Vulgaris
- Interventions
- Brodalumab, Fumaric acid esters
- First posted
- 2017-11-06
- Last updated
- 2025-03-13
- Other registries' IDs
- eudract:2016-003867-21
- Results first posted
- 2020-02-10
- Limitations and caveats
Operational challenges with the ePRO diary device given to trial participants led to missing data at baseline and Week 24. This made the analyses of the secondary patient-reported endpoints PSI response rate and PSI total score of 0 or 1 impossible.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Having Least 75% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 75 Response) From Baseline at Week 24 | Baseline to Week 24 | The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region. Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease). |
| Primary | Static Physician's Global Assessment (sPGA) Scale Score of 0 or 1 at Week 24 | Baseline to Week 24 | sPGA is a 6-point scale that represents the average lesion severity on the trunk and limbs. The assessment is based on the condition of the disease at the time of evaluation. Static Physician's Global Assessment is a scale ranging rom 0 (clear skin) to 5 (severe disease). |
| Secondary | Having Least 90% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 90 Response) From Baseline at Week 24 | Baseline to Week 24 | The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region. Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease). |
| Secondary | Having 100% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 100 Response) From Baseline at Week 24 | Baseline to Week 24 | The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region. Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease). |
| Secondary | Change From Baseline at Week 24 in PASI Score | Baseline to Week 24 | The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region. Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease). A negative change in PASI score means that the PASI score was lower at the time of data collection. |
| Secondary | Percent Change From Baseline in PASI Score at Week 24 | Baseline to Week 24 | The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region. Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease). A negative value in the percent change from baseline that the PASI score was lower at the time of data collection. |
| Secondary | Change From Baseline at Week 24 in Affected Body Surface Area (BSA) | Baseline to Week 24 | The surface area of the participant's hand (palm and fingers) is used as a reference measurement to calculate the percentage of each body region that is affected by psoriasis. One hand is approximately equal to 1% total BSA. Furthermore, the complete body surface area (BSA=100%) can be divided into regions that approximates percentages of BSA as follows: head and neck (10%), upper extremities (20%), the trunk including the axillae and groin (30%), and finally the lower extremities, including the buttocks (40%). A negative value in the percent change from baseline that the affected BSA was lower at the time of data collection. |
| Secondary | Psoriasis Symptom Inventory (PSI) Responder at Week 24 (Total Score ≤ 8, With no Item Scores > 1) | Week 24 | The PSI consists of eight psoriasis-specific questions. Trial participants rated the severity of their symptoms in the last 24 hours from 'not at all' to 'very severe,' ranging from 0 to 4. Total scores range from 0 to 32 with higher scores indicating worse symptoms. PSI response is defined as total score ≤8 and no item score \>1. Symptom-free day is defined as having daily total PSI of 0 on that day. |
| Secondary | PSI Total Score of 0 at Week 24 | Week 24 | The PSI consists of eight psoriasis-specific questions. Trial participants rated the severity of their symptoms in the last 24 hours from 'not at all' to 'very severe,' ranging from 0 to 4. Total scores range from 0 to 32 with higher scores indicating worse symptoms. PSI response is defined as total score ≤8 and no item score \>1. Symptom-free day is defined as having daily total PSI of 0 on that day. |
| Secondary | Number of Symptom-free Days From Randomisation to Week 24 | Baseline to Week 24 | The PSI consists of eight psoriasis-specific questions. Trial participants rated the severity of their symptoms in the last 24 hours from 'not at all' to 'very severe,' ranging from 0 to 4. Total scores range from 0 to 32 with higher scores indicating worse symptoms. PSI response is defined as total score ≤8 and no item score \>1. Symptom-free day is defined as having daily total PSI of 0 on that day. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Having Least 75% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 75 Response) From Baseline at Week 24 | Baseline to Week 24 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Static Physician's Global Assessment (sPGA) Scale Score of 0 or 1 at Week 24 | Baseline to Week 24 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Having Least 90% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 90 Response) From Baseline at Week 24 | Baseline to Week 24 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Having 100% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 100 Response) From Baseline at Week 24 | Baseline to Week 24 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change From Baseline at Week 24 in PASI Score | Baseline to Week 24 | The number of analysed participants is not the same as the number of randomised participants, as participants with missing data in all visits for a given endpoint are not included in the mixed model for repeated measurements (MMRM) analysis used to analyse the endpoint. | score on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in PASI Score at Week 24 | Baseline to Week 24 | The number of analysed participants is not the same as the number of randomised participants, as participants with missing data in all visits for a given endpoint are not included in the mixed model for repeated measurements (MMRM) analysis used to analyse the endpoint. | percent change in PASI | MEAN |
| SECONDARY | Change From Baseline at Week 24 in Affected Body Surface Area (BSA) | Baseline to Week 24 | percent change | MEAN | |
| SECONDARY | Psoriasis Symptom Inventory (PSI) Responder at Week 24 (Total Score ≤ 8, With no Item Scores > 1) | Week 24 | PSI data was missing for many participants at baseline and Week 24. For this reason, no statistical analysis was performed. The data shown is therefore descriptive data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | PSI Total Score of 0 at Week 24 | Week 24 | PSI data was missing for many participants at baseline and Week 24. For this reason, no statistical analysis was performed. The data shown is therefore descriptive data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Symptom-free Days From Randomisation to Week 24 | Baseline to Week 24 | PSI data was missing for many participants at baseline and Week 24. For this reason, no statistical analysis was performed. | days | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Having Least 75% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 75 Response) From Baseline at Week 24 | Brodalumab | 85 | Participants | ||
| Having Least 75% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 75 Response) From Baseline at Week 24 | Fumaric Acid Esters | 40 | Participants | ||
| Static Physician's Global Assessment (sPGA) Scale Score of 0 or 1 at Week 24 | Brodalumab | 68 | Participants | ||
| Static Physician's Global Assessment (sPGA) Scale Score of 0 or 1 at Week 24 | Fumaric Acid Esters | 21 | Participants | ||
| Having Least 90% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 90 Response) From Baseline at Week 24 | Brodalumab | 69 | Participants | ||
| Having Least 90% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 90 Response) From Baseline at Week 24 | Fumaric Acid Esters | 23 | Participants | ||
| Having 100% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 100 Response) From Baseline at Week 24 | Brodalumab | 42 | Participants | ||
| Having 100% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 100 Response) From Baseline at Week 24 | Fumaric Acid Esters | 9 | Participants | ||
| Change From Baseline at Week 24 in PASI Score | Brodalumab | -15.69 | Standard Error 0.59 | score on a scale | |
| Change From Baseline at Week 24 in PASI Score | Fumaric Acid Esters | -12.62 | Standard Error 0.67 | score on a scale |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brodalumab | 105 | |
| Overall Study | STARTED | Fumaric Acid Esters | 105 | |
| Overall Study | COMPLETED | Brodalumab | 91 | |
| Overall Study | COMPLETED | Fumaric Acid Esters | 58 | |
| Overall Study | NOT COMPLETED | Brodalumab | 14 | |
| Overall Study | NOT COMPLETED | Fumaric Acid Esters | 47 |
Source ClinicalTrials.gov
Adverse events38
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 | Lymphopenia | Blood and lymphatic system disorders | Brodalumab 210 mg | 2 | 104 | 3 |
| other | Lymphopenia | Blood and lymphatic system disorders | Fumaric Acid Ester | 14 | 102 | 14 |
| other | Abdominal pain | Gastrointestinal disorders | Brodalumab 210 mg | 2 | 104 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Fumaric Acid Ester | 11 | 102 | 13 |
| other | Abdominal pain upper | Gastrointestinal disorders | Brodalumab 210 mg | 2 | 104 | 2 |
| other | Abdominal pain upper | Gastrointestinal disorders | Fumaric Acid Ester | 28 | 102 | 43 |
| other | Diarrhoea | Gastrointestinal disorders | Brodalumab 210 mg | 4 | 104 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Fumaric Acid Ester | 59 | 102 | 77 |
| other | Nausea | Gastrointestinal disorders | Brodalumab 210 mg | 6 | 104 | 7 |
| other | Nausea | Gastrointestinal disorders | Fumaric Acid Ester | 9 | 102 | 13 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brodalumab 210 mg | 0 | 104 |
| Total, all-cause mortality | Fumaric Acid Ester | 0 | 102 |
| Total, other adverse events | Brodalumab 210 mg | 66 | 104 |
| Total, other adverse events | Fumaric Acid Ester | 90 | 102 |
| Total, serious adverse events | Brodalumab 210 mg | 3 | 104 |
| Total, serious adverse events | Fumaric Acid Ester | 1 | 102 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Brodalumab vs Fumaric Acid Esters: Having Least 75% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 75 Response) From Baseline at Week 24 | Trial comparisons |
| Brodalumab vs Fumaric Acid Esters: Psoriasis Symptom Inventory (PSI) Responder at Week 24 (Total Score ≤ 8, With no Item Scores > 1) | Trial comparisons |
| Brodalumab vs Fumaric Acid Esters: Having 100% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 100 Response) From Baseline at Week 24 | Trial comparisons |
| Brodalumab vs Fumaric Acid Esters: Having Least 90% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 90 Response) From Baseline at Week 24 | Trial comparisons |
| Brodalumab vs Fumaric Acid Esters: PSI Total Score of 0 at Week 24 | Trial comparisons |
| Brodalumab vs Fumaric Acid Esters: DLQI Total Score of 0 or 1 at Week 24 | Trial comparisons |
| Brodalumab 210 mg vs Fumaric Acid Ester: deaths from any cause | Trial comparisons |
| Brodalumab vs Fumaric Acid Esters: Static Physician's Global Assessment (sPGA) Scale Score of 0 or 1 at Week 24 | Trial comparisons |
| Brodalumab 210 mg vs Fumaric Acid Ester: serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03331835
GET https://conductscience.org/api/trials/v1/NCT03331835/results?page=2