Trial · NCT04305327
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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. |
| Secondary | Blood Levels of T-cell Subsets (CD4+ and CD8+), Assessed at Weeks 8, 12, and 52. | Week 8, Week 12, and Week 52 | Number of participants with detectable levels of T-cell subsets at weeks 8, 12, and 52. |
| Secondary | Serum Concentrations of Brodalumab, Assessed at Weeks 4, 8, 10, 12, 16, 22, and 52. | Week 4, Week 8, Week 10, Week 12, Week 16, Week 22, and Week 52 | Number of participants with detectable levels of brodalumab at weeks 4, 8, 10, 12, 16, 22, and 52. |
| Secondary | Anti-tetanus Toxoid Antibodies ≥0.1 IU/mL, Assessed at Week 12. | Week 12 | Number of participants with detectable levels of anti-tetanus toxoid antibodies at weeks 12. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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