Trial · NCT04204616
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events (AEs) by Severity | Up to 192 weeks | Incidence of AEs including AEs of Special Interest (AESIs), Treatment Emergent AEs (TEAEs) and Serious AEs (SAEs) by severity as mild, moderate or severe will be reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with relevant investigational product. SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. TEAE is an AE that occurs on or after the first date of study drug(s) administration until the date of last study visit. An AESI is a noteworthy treatment-emergent event for the study drug that should be monitored closely and reported promptly. |
| Secondary | Percentage of Participants with an Investigator Global Assessment (IGA) Success up to Week 184 | Up to Week 184 | Percentage of participants with an IGA success (defined as IGA of 0 \[Clear\] or 1 \[Almost clear\]) up to Week 184 will be reported. |
| Secondary | Percentage of Participants with an Improvement of >=4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) up to Week 184 | Baseline up to Week 184 | Percentage of participants with an improvement of \>= 4 from baseline in PP NRS up to Week 184 will be reported. The PP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". |
| Secondary | Percentage of Participants with Low Disease Activity State up to Week 184 | Up to Week 184 | Percentage of participants with low disease activity state (that is, IGA less than or equal to \[\<=\]2) up to Week 184 will be reported. |
| Secondary | Percentage of Pruriginous Lesions with Excoriations/Crusts up (PAS item 5a) up to Week 184 | Up to Week 184 | Prurigo Activity Score (PAS) will include a count of the number of lesions in a representative area and a calculated staging (stage 0 to stage 4) based on the percentage of lesions with excoriations/crusts and healed lesions compared to all lesions. PAS item 5a reflects the current itch/scratch activity. It is used to estimate what percentage of the pruriginous legions show excoriations/crusts. 100 percent (%) = All pruriginous lesions have excoriations/crusts. Percentage of pruriginous lesions with excoriations/crusts (PAS item 5a) up to Week 184 will be reported. |
| Secondary | Percentage of Healed Prurigo Lesions (PAS item 5b) up to Week 184 | Up to Week 184 | PAS item 5b item reflects the stage of the prurigo. It is used to estimate what percentage of the pruriginous lesions have healed.100% = all pruriginous lesions have healed. Percentage of healed prurigo lesions (PAS item 5b) up to Week 184 will be reported. |
| Secondary | Change from Baseline in Number of Lesions in Representative Area (PAS item 4) up to Week 184 | Baseline up to Week 184 | Change from baseline in number of lesions in representative area (PAS item 4) up to Week 184 will be reported. |
| Secondary | Percentage of Participants with PP NRS <2 up to Week 184 | Up to Week 184 | Percentage of participants with PP NRS \<2 up to Week 184 will be reported. PP NRS is a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". |
| Secondary | Percent Change from Baseline in PP NRS up to Week 184 | Baseline up to Week 184 | Percent change from baseline in PP NRS up to Week 184 will be reported. PP NRS is a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". |
| Secondary | Absolute Change from Baseline in PP NRS up to Week 184 | Baseline up to Week 184 | Absolute change from baseline in PP NRS up to Week 184 will be reported. PP NRS is a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". |
| Secondary | Percentage of Participants with Average Pruritus (AP) NRS <2 up to Week 52 | Up to Week 52 | Percentage of participants with AP NRS less than (\<) 2 up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". |
| Secondary | Percentage of Participants with an Improvement of >=4 from Baseline in AP NRS up to Week 52 | Up to Week 52 | Percentage of participants with an improvement of \>=4 from baseline in AP NRS up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". |
| Secondary | Percent Change from Baseline in AP NRS up to Week 52 | Up to Week 52 | Percent change from baseline in AP NRS up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". |
| Secondary | Absolute Change from Baseline in AP NRS up to Week 52 | Up to Week 52 | Absolute change from baseline in AP NRS up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". |
| Secondary | Percentage of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance (SD) NRS up to Week 184 | Up to Week 184 | Percentage of participants with an improvement of \>=4 from baseline in Sleep Disturbance (SD) NRS up to Week 184 will be reported. SD NRS has a scale of 0 to 10, with 0 being "no sleep loss related to the symptoms of my skin disease (prurigo nodularis)" and 10 being "I did not sleep at all due to the symptoms of my skin disease (prurigo nodularis)". |
| Secondary | Percent Change from Baseline in SD NRS up to Week 184 | Up to Week 184 | Percent change from baseline in SD NRS up to Week 184 will be reported. SD NRS has a scale of 0 to 10, with 0 being "no sleep loss related to the symptoms of my skin disease (prurigo nodularis)" and 10 being "I did not sleep at all due to the symptoms of my skin disease (prurigo nodularis)". |
| Secondary | Absolute Change from Baseline in SD NRS up to Week 184 | Up to Week 184 | Absolute change from baseline in SD NRS up to Week 184 will be reported. SD NRS has a scale of 0 to 10, with 0 being "no sleep loss related to the symptoms of my skin disease (prurigo nodularis)" and 10 being "I did not sleep at all due to the symptoms of my skin disease (prurigo nodularis)". |
| Secondary | Change from Baseline in Prurigo Nodularis (PN)-associated Pain Frequency up to Week 184 | Baseline up to Week 184 | Change from baseline in PN-associated pain frequency up to Week 184 will be reported. The pain frequency will be assessed on a scale of 0 to 5 where 0 = never, 1 = less than once a week, 2 = 1-2 days a week, 3 = 3-4 days a week, and 4 = 5-6 days a week. |
| Secondary | Change from Baseline in PN-associated Pain Intensity up to Week 184 | Baseline up to Week 184 | Change from baseline in PN-associated pain intensity up to Week 184 will be reported. The pain intensity will be assessed on a scale of 0 to 10, with 0 being "no pain" and 10 being "the worst unbearable pain". |
| Secondary | Percentage of Participants Reporting low Disease Activity Based on Patient Global Assessment of Disease (PGAD) up to Week 52 | Up to Week 52 | Percentage of participants reporting low disease activity (clear, almost clear, or mild) based on Patient Global Assessment of Disease (PGAD) up to Week 52 to be reported. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04204616/registered