Trial · NCT05764161
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | WI-NRS4 Response at Week 12 | Baseline; Week 12 | WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in Worst-Itch Numeric Rating Scale (WI-NRS) score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1). The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. Participants with missing Week 12 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders. |
| Secondary | WI-NRS4 Response at Week 4 | Baseline; Week 4 | WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in WI-NRS score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1). The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. |
| Secondary | Percentage of Participants With Overall-Treatment Success at Week 12 | Baseline; Week 12 | Overall-Treatment Success was defined as both a WI-NRS4 response and Investigator's Global Assessment for Stage of Chronic Prurigo Treatment Success (IGA-CPG-S-TS). IGA-CPG-S-TS was defined as an IGA-CPG-S score of 0 or 1 with a ≥2 grade improvement from baseline. The IGA-CPG-S is an overall severity rating of chronic prurigo on a scale of 0 to 4: 0, clear (no pruriginous lesions); 1, almost clear (rare palpable pruriginous lesions \[approximately 1-5 lesions\]); 2, mild (few palpable pruriginous lesions \[approximately 6-19 lesions\]); 3, moderate (many palpable pruriginous lesions \[approximately 20-100 lesions\]); 4, severe (abundant palpable pruriginous lesions \[over 100 lesions\]). |
| Secondary | Percentage of Participants With IGA-CPG-S-TS at Week 12 | Baseline; Week 12 | IGA-CPG-S-TS was defined as an IGA-CPG-S score of 0 or 1 with a ≥2 grade improvement from baseline. The IGA-CPG-S is an overall severity rating of chronic prurigo on a scale of 0 to 4: 0, clear (no lesions); 1, almost clear (rare palpable pruriginous lesions \[approximately 1-5 lesions\]); 2, mild (few palpable pruriginous lesions \[approximately 6-19 lesions\]); 3, moderate (many palpable pruriginous lesions \[approximately 20-100 lesions\]); 4, severe (abundant palpable pruriginous lesions \[over 100 lesions\]). |
| Secondary | WI-NRS4 Response at Day 7 | Baseline; Day 7 | WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in WI-NRS score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1). The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. |
| Secondary | WI-NRS4 Response at Each Post-baseline Visit | Baseline; up to Week 52 | WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in WI-NRS score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1). The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. |
| Secondary | DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Baseline; up to Week 12 | The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1). The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. |
| Secondary | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Baseline; up to Week 52 | The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1). The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. |
| Secondary | Time to ≥2-point Improvement From Baseline in WI-NRS Score | Baseline; up to Week 12 | The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1). The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. |
| Secondary | Time to ≥4-point Improvement From Baseline in WI-NRS Score | Baseline; up to Week 12 | The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1). The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. |
| Secondary | DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Baseline; up to Week 12 | Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1). The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day. |
| Secondary | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Baseline; up to Week 52 | Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1). The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day. |
| Secondary | DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Baseline; up to Week 12 | Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1). The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day. Change from baseline was calculated as the post-baseline value minus the baseline value. |
| Secondary | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Baseline; up to Week 52 | Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1). The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day. Change from baseline was calculated as the post-baseline value minus the baseline value. |
| Secondary | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Baseline; up to Week 52 | IGA-CPG-S-TS was defined as an IGA-CPG-S score of 0 or 1 with a ≥2 grade improvement from baseline. The IGA-CPG-S is an overall severity rating of chronic prurigo nodularis on a scale of 0 to 4: 0, clear (no lesions); 1, almost clear (rare palpable pruriginous lesions \[approximately 1-5 lesions\]); 2, mild (few palpable pruriginous lesions \[approximately 6-19 lesions\]); 3, moderate (many palpable pruriginous lesions \[approximately 20-100 lesions\]); 4, severe (abundant palpable pruriginous lesions \[over 100 lesions\]). |
| Secondary | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Baseline; up to Week 52 | The Investigator Global Assessment for Activity of Chronic Prurigo (IGA-CPG-A) is an overall severity rating of chronic prurigo nodularis on a scale of 0 to 4: 0, clear (no pruriginous lesions have excoriations or crusts); 1, almost clear (very small proportion of pruriginous lesions have excoriations or crusts \[up to approximately 10% of all pruriginous lesions\]); 2, mild (minority of pruriginous lesions have excoriations or crusts \[approximately 11%-25% of all pruriginous lesions\]); 3, moderate (many pruriginous lesions have excoriations or crusts \[approximately 26%-75% of all pruriginous lesions\]); 4, severe (majority of pruriginous lesions have excoriations or crusts \[approximately 76%-100% of all pruriginous lesions\]). |
| Secondary | DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit | Baseline; up to Week 12 | The extent and severity of prurigo nodularis was assessed via the PAS (version 1.2). The first 3 items are descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions. The remaining 2 items of the PAS assess disease activity in terms of percentage (i.e., 0%, 1%-25%, 26%-50%, 51%-75%, and 76%-100%) of pruriginous lesions with excoriations/crusts on top (to reflect active scratching) and the percentage (i.e., 100%, 76%-99%, 51%-75%, 26%-50%, and 0%-25%) of healed pruriginous lesions in order to quantify change of prurigo nodularis skin lesions. |
| Secondary | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Baseline; up to Week 52 | The extent and severity of prurigo nodularis was assessed via the PAS (version 1.2). The first 3 items are descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions. The remaining 2 items of the PAS assess disease activity in terms of percentage (i.e., 0%, 1%-25%, 26%-50%, 51%-75%, and 76%-100%) of pruriginous lesions with excoriations/crusts on top (to reflect active scratching) and the percentage (i.e., 100%, 76%-99%, 51%-75%, 26%-50%, and 0%-25%) of healed pruriginous lesions in order to quantify change of prurigo nodularis skin lesions. |
| Secondary | DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit | Baseline; up to Week 12 | The DLQI is a simple, 10-question, validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Each question was scored as: 3 (very much), 2 (a lot), 1 (a little), 0 (not at all or not relevant). The DLQI total score was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more the quality of life was impaired. Total DLQI scores were categorized as follows: 0 to 1 (no effect), 2 to 5 (small effect), 6 to 10 (moderate effect), 11 to 20 (very large effect), and 21 to 30 (extremely large effect). Change from Baseline was calculated as the post-baseline visit minus the baseline visit. |
| Secondary | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Baseline; up to Week 52 | The DLQI is a simple, 10-question, validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Each question was scored as: 3 (very much), 2 (a lot), 1 (a little), 0 (not at all or not relevant). The DLQI total score was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more the quality of life was impaired. Total DLQI scores were categorized as follows: 0 to 1 (no effect), 2 to 5 (small effect), 6 to 10 (moderate effect), 11 to 20 (very large effect), and 21 to 30 (extremely large effect). Change from Baseline was calculated as the post-baseline visit minus the baseline visit. |
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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