Trial · NCT06516965
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at Week 24 | Week 24 | Defined as proportion of participants achieving a ≥ 4-point improvement \[reduction\] in Itch NRS score from baseline (Itch NRS4) and an IGA CPG-S score of 0 or 1 with a ≥ 2-grade improvement from baseline (IGA-CPG-S-TS). |
| Secondary | Proportion of participants achieving Itch NRS4 at Week 24 | Week 24 | Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score from baseline. |
| Secondary | Proportion of participants achieving IGA-CPG-S-TS at Week 24 | Week 24 | Defined as percentage of participants that achieve IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline. |
| Secondary | Proportion of participants achieving Itch NRS4 at Week 4 | Week 4 | Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score from baseline. |
| Secondary | Time to Itch NRS4 | Up to 52 Weeks | Defined as time taken for the participant to achieve a ≥4 improvement in Itch NRS score from baseline. |
| Secondary | Change from baseline in Itch NRS score at each postbaseline visit | Up to 52 weeks | Itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable". |
| Secondary | Percent change from baseline in NRS score at each postbaseline visit | Up to 52 weeks | Itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable". |
| Secondary | Proportion of participants achieving Itch NRS4 at each postbaseline visit | Up to 52 weeks | Defined as percentage of participants that achieve a ≥ 4-point improvement in Itch NRS score from baseline. |
| Secondary | Proportion of participants achieving IGA-CPG-S-TS at each postbaseline visit | Up to 52 weeks | Defined as percentage of participants that achieve an IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline. |
| Secondary | Proportion of participants achieving Investigator's Global Assessment - Chronic Prurigo Activity (IGA-CPG-A) at each postbaseline visit | Up to 52 weeks | Defined as percentage of participants that achieve an IGA-CPG-A score of 0 or 1 with a ≥ 2 grade improvement (reduction) from baseline. |
| Secondary | Proportion of participants achieving ≥ 75% healed lesions in Prurigo Activity Score (PAS) at each postbaseline visit | Up to 52 weeks | The modified PAS will be used in this study as defined by the protocol. |
| Secondary | Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at each postbaseline visit | Up to 52 weeks | Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score and IGA-CPG-S score of 0 or 1 with a ≥ 2-grade improvement from baseline. |
| Secondary | Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit. | Up to 52 weeks | 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. |
| Secondary | Percent change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit. | Up to 52 weeks | 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. |
| Secondary | Proportion of participants with at least a 4-point decrease in DLQI score from baseline at each postbaseline visit for participants with DLQI score ≥ 4 at baseline | Up to 52 weeks | Defined as percentage of participants with at least a 4-point decrease in DLQI score from baseline at each postbaseline visit for participants with DLQI score ≥ 4 at baseline. |
| Secondary | Change from baseline in Skin Pain NRS score at each postbaseline visit | Up to 52 weeks | Skin Pain NRS is an 11-point scale (0 to10) where 0 is "no pain" and 10 is the "worst pain imaginable". |
| Secondary | Percent change from baseline in Skin Pain NRS score at each postbaseline visit | Up to 52 weeks | Skin Pain NRS is an 11-point scale (0 to10) where 0 is "no pain" and 10 is the "worst pain imaginable". |
| Secondary | Change from baseline in the Hospital Anxiety and Depression Scale (HADS) score at each postbasline visit | Up to 52 weeks | HADS is a 14-item questionnaire that assesses the levels of anxiety and depression that a participant is currently experiencing. There are 7 questions each for measuring anxiety and for measuring depression, with 4 possible responses to each question (responses are scored as 0, 1, 2, or 3). |
| Secondary | Percent change from baseline in the HADS score at each postbaseline visit | Up to 52 weeks | HADS is a 14-item questionnaire that assesses the levels of anxiety and depression that a participant is currently experiencing. There are 7 questions each for measuring anxiety and for measuring depression, with 4 possible responses to each question (responses are scored as 0, 1, 2, or 3). |
| Secondary | Change from baseline in EQ-5D-5L score at each postbaseline visit | Up to 52 weeks | The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome. |
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
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