Trial · NCT06323356
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 | Percentage of Participants Who Achieved a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a Greater Than or Equal to (>=) 2-Point Decrease From Baseline at Week 16 | At Week 16 | The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. |
| Primary | Percentage of Participants Who Achieved >=75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16 | At Week 16 | PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produced a numeric score that ranged from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score were reported. |
| Secondary | Percentage of Participants Who Achieved an sPGA of Clear (0) or Almost Clear (1) With a >=2-Point Decrease From Baseline at Week 52 | At Week 52 | The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting. |
| Secondary | Percentage of Participants Who Achieved an sPGA of Clear (0) or Almost Clear (1) With a >=2-Point Decrease From Baseline at Both Weeks 16 and 52 | At both Weeks 16 and 52 | The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting. |
| Secondary | Percentage of Participants Who Achieved an sPGA of Clear (0) at Weeks 16 and 52 | At Weeks 16 and 52 | The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting. |
| Secondary | Percentage of Participants Who Achieved an sPGA of Clear (0) or Almost Clear (1) at Weeks 16 and 52 | At Weeks 16 and 52 | The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting. |
| Secondary | Percentage of Participants Who Achieved an sPGA of Clear (0) or Almost Clear (1) at Both Weeks 16 and 52 | At both Weeks 16 and 52 | The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting. |
| Secondary | Percentage of Participants Who Achieved PASI-75 at Week 52 | At Week 52 | PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produced a numeric score that ranged from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score are reported. The results will be disclosed during final posting. |
| Secondary | Percentage of Participants Who Achieved PASI-90 at Weeks 16 and 52 | At Weeks 16 and 52 | PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produced a numeric score that ranged from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score are reported. The results will be disclosed during final posting. |
| Secondary | Percentage of Participants Who Achieved PASI-100 at Weeks 16 and 52 | At Weeks 16 and 52 | PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produced a numeric score that ranged from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing 100% improvement in PASI score relative to baseline PASI score are reported. The results will be disclosed during final posting. |
| Secondary | Percentage of Participants Who Achieved PASI-75 at Both Weeks 16 and 52 | At both Weeks 16 and 52 | PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produced a numeric score that ranged from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score are reported. The results will be disclosed during final posting. |
| Secondary | Percentage of Participants Who Achieved PASI-90 at Both Weeks 16 and 52 | At both Weeks 16 and 52 | PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produced a numeric score that ranged from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score are reported. The results will be disclosed during final posting. |
| Secondary | Percentage of Participants Who Achieved a Scalp-specific Physician's Global Assessment (ssPGA) of Absence of Disease (0) or Very Mild Disease (1) With a >=2-Point Decrease From Baseline at Weeks 16 and 52 | At Weeks 16 and 52 | ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions were evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicated worsening. The results will be disclosed during final posting. |
| Secondary | Change From Baseline in ssPGA at Weeks 16 and 52 | Baseline, Weeks 16 and 52 | ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions were evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicated worsening. The results will be disclosed during final posting. |
| Secondary | Percentage of Participants Who Achieved a PGA of the Hands and/or Feet of Clear (0) or Almost Clear (1) With a >=2-Point Decrease From Baseline at Weeks 16 and 52 | At Weeks 16 and 52 | PGA is a 5-point scale and a score of 0 to 4 was assigned, based on the category that best described the severity of active psoriasis of the participant's hands and feet, where 0=clear and 4=severe. Higher scores indicated worsening of severity. It was evaluated for participants with the presence of active hand or foot psoriasis on Day 1. The results will be disclosed during final posting. |
| Secondary | Percentage of Participants With a Baseline Dermatology Life Quality Index (DLQI) Score >=2 Who Achieved DLQI Score of 0 or 1 at Weeks 16 and 52 | At Weeks 16 and 52 | The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's quality of life (QoL) during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicated: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life). The results will be disclosed during final posting. |
| Secondary | Change From Baseline in DLQI at Weeks 16 and 52 | Baseline, Weeks 16 and 52 | The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's quality of life (QoL) during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicated: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life). The results will be disclosed during final posting. |
| Secondary | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Weeks 16 and 52 Among Participants With Nail Involvement at Baseline | Baseline, Weeks 16 and 52 | The NAPSI quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on the lunula, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each nail was scored for both nail matrix and nail bed psoriasis for each quadrant (ranging from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all fingernails evaluated and ranged from 0 to 80. Higher scores indicated more severe psoriasis. The results will be disclosed during final posting. |
| Secondary | Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Weeks 16 and 52 | Baseline, Weeks 16 and 52 | Psoriasis BSA was assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represented 1% BSA. The sum of handprints equated to the total surface area of involvement. The results will be disclosed during final posting. |
| Secondary | Percent Change From Baseline in BSA Affected by Psoriasis at Weeks 16 and 52 | Baseline, Weeks 16 and 52 | Psoriasis BSA was assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represented 1% BSA. The sum of handprints equated to the total surface area of involvement. The results will be disclosed during final posting. |
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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