Trial · NCT04305327
Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis
NCT04305327, Phase 3, Terminated, LEO Pharma; results first posted 2024-02-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis. Trials, record NCT04305327. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04305327
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis
- NCT number
- NCT04305327
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 12 participants, actual
- Lead sponsor
- LEO Pharma
- Conditions
- Psoriasis
- Interventions
- Brodalumab, Ustekinumab, Placebo
- First posted
- 2020-03-12
- Last updated
- 2025-03-14
- Other registries' IDs
- eudract:2019-001868-30
- Results first posted
- 2024-02-28
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Psoriasis Area and Severity Index (PASI) 75 Response, Assessed at Week 12. | Baseline to Week 12 | PASI 75 response is defined as having at least 75% improvement in PASI score from baseline. The severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions, head/neck, trunk, upper extremities, and lower extremities, were assessed according to a severity scale. The extent of psoriasis within each of the 4 body regions was also assessed. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition. |
| Secondary | Static Physician's Global Assessment (sPGA) Score of 0 or 1, Assessed at Week 12. | Week 12 | The sPGA is an instrument used in clinical trials to rate the severity of the participant's global psoriasis and is based on a 6-point scale ranging from 0 (clear) to 5 (very severe). The number of participants achieving a score of 0 (clear) or 1 (almost clear) was assessed. |
| Secondary | sPGA Score of 0, Assessed at Week 12. | Week 12 | The sPGA is an instrument used in clinical trials to rate the severity of the participant's global psoriasis and is based on a 6-point scale ranging from 0 (clear) to 5 (very severe). The number of participants achieving a score of 0 (clear) or 1 (almost clear) was assessed. |
| Secondary | PASI 90 Response, Assessed at Week 12. | Baseline to Week 12 | PASI 90 response is defined as having at least 90% improvement in PASI score from baseline. The severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions, head/neck, trunk, upper extremities, and lower extremities, will be assessed according to a severity scale. The extent of psoriasis within each of the 4 body regions will also be assessed. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition. |
| Secondary | PASI 100 Response, Assessed at Week 12. | Baseline to Week 12 | PASI 100 response is defined as having at least 100% improvement in PASI score from baseline. The severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions, head/neck, trunk, upper extremities, and lower extremities, will be assessed according to a severity scale. The extent of psoriasis within each of the 4 body regions will also be assessed. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition. |
| Secondary | Children's Dermatology Life Quality Index (CDLQI) Total Score of 0 or 1, Assessed at Week 12. | Week 12 | CDLQI consists of 10 items addressing the child's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point scale ranging from 0 (not at all) to 3 (very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life. |
| Secondary | Family Dermatology Life Quality Index (FDLQI) Total Score of 0 or 1, Assessed at Week 12. | Week 12 | FDLQI consists of 10 items addressing the participant's relative perception of the impact of the participant's skin disease on various aspects of his/her quality of life over the last month such as: emotional distress, social life, job and leisure activities, physical well-being, time spent on helping the subject with e.g., treatment procedures, extra housework, and routine household expenditure. Each item is scored on a 4-point scale ranging from 0 (not at all) to 3 (very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life. |
| Secondary | Overall Number of Adverse Events (AEs) | Up to approximately 5 months | An AE is defined as any untoward medical occurrence in subjects or clinical investigation participants administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A serious AE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the patient or may require medical or surgical intervention to prevent any of the outcomes listed above. |
| Secondary | Presence of Anti-drug Antibodies, Assessed at Weeks 4, 16, and 52. | Week 4, Week 16, and Week 52 | Number of participants with a positive post-baseline anti-drug antibody result at weeks 4, 16, and 52. |
| Secondary | Serum Concentration of Interleukin-17, Assessed at Weeks 8, 12, and 52. | Week 8, Week 12, and Week 52 | Number of participants with detectable levels of Interleukin-17 at weeks 8, 12, and 52. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Psoriasis Area and Severity Index (PASI) 75 Response, Assessed at Week 12. | Baseline to Week 12 | Participants who completed at Week 12 are included in the overall number of participants analysed. Dataset from the full analysis set (FAS) which includes all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Static Physician's Global Assessment (sPGA) Score of 0 or 1, Assessed at Week 12. | Week 12 | Due to early termination, data was not collected | ||
| SECONDARY | sPGA Score of 0, Assessed at Week 12. | Week 12 | Due to early termination, data was not collected | ||
| SECONDARY | PASI 90 Response, Assessed at Week 12. | Baseline to Week 12 | Participants who completed at Week 12 are included in the overall number of participants analysed. Dataset from the FAS which includes all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | PASI 100 Response, Assessed at Week 12. | Baseline to Week 12 | Participants who completed at Week 12 are included in the overall number of participants analysed. Dataset from the FAS which includes all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Children's Dermatology Life Quality Index (CDLQI) Total Score of 0 or 1, Assessed at Week 12. | Week 12 | Due to early termination, data was not collected | ||
| SECONDARY | Family Dermatology Life Quality Index (FDLQI) Total Score of 0 or 1, Assessed at Week 12. | Week 12 | Due to early termination, data was not collected | ||
| SECONDARY | Overall Number of Adverse Events (AEs) | Up to approximately 5 months | Dataset from the safety analysis set (SAS) which includes all participants who received at least 1 dose of IMP. | Adverse events | NUMBER |
| SECONDARY | Presence of Anti-drug Antibodies, Assessed at Weeks 4, 16, and 52. | Week 4, Week 16, and Week 52 | Due to early termination, data was not collected | ||
| SECONDARY | Serum Concentration of Interleukin-17, Assessed at Weeks 8, 12, and 52. | Week 8, Week 12, and Week 52 | Due to early termination, data was not collected |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Psoriasis Area and Severity Index (PASI) 75 Response, Assessed at Week 12. | Brodalumab | NA | Participants | ||
| Psoriasis Area and Severity Index (PASI) 75 Response, Assessed at Week 12. | Placebo/Ustekinumab | NA | Participants | ||
| PASI 90 Response, Assessed at Week 12. | Brodalumab | NA | Participants | ||
| PASI 90 Response, Assessed at Week 12. | Placebo/Ustekinumab | NA | Participants | ||
| PASI 100 Response, Assessed at Week 12. | Brodalumab | NA | Participants | ||
| PASI 100 Response, Assessed at Week 12. | Placebo/Ustekinumab | NA | Participants | ||
| Overall Number of Adverse Events (AEs) | Brodalumab | Any AEs | 4 | Adverse events | |
| Overall Number of Adverse Events (AEs) | Ustekinumab | Any AEs | 5 | Adverse events | |
| Overall Number of Adverse Events (AEs) | Placebo/Brodalumab | Any AEs | 0 | Adverse events | |
| Overall Number of Adverse Events (AEs) | Placebo/Ustekinumab | Any AEs | 3 | Adverse events |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brodalumab | 2 | |
| Overall Study | STARTED | Ustekinumab | 6 | |
| Overall Study | STARTED | Placebo/Brodalumab | 2 | |
| Overall Study | STARTED | Placebo/Ustekinumab | 2 | |
| Overall Study | COMPLETED | Brodalumab | 0 | |
| Overall Study | COMPLETED | Ustekinumab | 0 | |
| Overall Study | COMPLETED | Placebo/Brodalumab | 0 | |
| Overall Study | COMPLETED | Placebo/Ustekinumab | 0 | |
| Overall Study | NOT COMPLETED | Brodalumab | 2 | |
| Overall Study | NOT COMPLETED | Ustekinumab | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events40
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 | Nasopharyngitis | Infections and infestations | Brodalumab | 1 | 2 | 1 |
| other | Nasopharyngitis | Infections and infestations | Ustekinumab | 2 | 6 | 2 |
| other | Nasopharyngitis | Infections and infestations | Placebo/Brodalumab | 0 | 2 | 0 |
| other | Nasopharyngitis | Infections and infestations | Placebo/Ustekinumab | 0 | 2 | 0 |
| other | Gastroenteritis | Infections and infestations | Brodalumab | 1 | 2 | 1 |
| other | Gastroenteritis | Infections and infestations | Ustekinumab | 0 | 6 | 0 |
| other | Gastroenteritis | Infections and infestations | Placebo/Brodalumab | 0 | 2 | 0 |
| other | Gastroenteritis | Infections and infestations | Placebo/Ustekinumab | 0 | 2 | 0 |
| other | Rhinitis | Infections and infestations | Brodalumab | 0 | 2 | 0 |
| other | Rhinitis | Infections and infestations | Ustekinumab | 0 | 6 | 0 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brodalumab | 0 | 2 |
| Total, all-cause mortality | Ustekinumab | 0 | 6 |
| Total, all-cause mortality | Placebo/Brodalumab | 0 | 2 |
| Total, all-cause mortality | Placebo/Ustekinumab | 0 | 2 |
| Total, other adverse events | Brodalumab | 2 | 2 |
| Total, other adverse events | Ustekinumab | 3 | 6 |
| Total, other adverse events | Placebo/Brodalumab | 0 | 2 |
| Total, other adverse events | Placebo/Ustekinumab | 2 | 2 |
| Total, serious adverse events | Brodalumab | 0 | 2 |
| Total, serious adverse events | Ustekinumab | 0 | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 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.
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/NCT04305327
GET https://conductscience.org/api/trials/v1/NCT04305327/events?page=2