Trial · NCT03713320
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Achieving an Objective Skin Response of at Least 4 Months Duration (ORR4) | Date of first dose through the earlier of last study visit or interim analysis data cut-off date of 12-Oct-2020, up to 16 months | ORR4 is the percentage of subjects with a complete response (CR) or partial response (PR) in the skin for 4 consecutive months confirmed by repeat assessments no less than 28 days (± 3 days) later. The modified Severity Weighted Assessment Tool (mSWAT) is used to measure skin disease severity based on the percentage of body surface area (BSA) with patches, plaques, or tumors. Total scores are calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores. Lower scores indicate a lower degree of skin disease severity. CR corresponds to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponds to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors. |
| Secondary | Progression-free Survival (PFS) | Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Time from date of randomization until the date of earliest documented progression or death from any cause. The duration of PFS was censored at the date of the last mSWAT assessment if the subject was alive and had no documented progression. Disease progression in the skin is defined as ≥ 25% increase in mSWAT score from baseline or, in participants with complete or partial response, increase in mSWAT score of greater than the sum of the nadir plus 50% baseline score. |
| Secondary | Complete Response Rate | Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Percentage of subjects with a complete response in the skin based on mSWAT |
| Secondary | Time to Progression | Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Time from date of randomization until the earliest date of confirmed progression |
| Secondary | Time to Maximal Effect in mSWAT | Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Time to greatest improvement in mSWAT score |
| Secondary | Objective Response Rate in the Skin of at Least 28-days Duration (ORR1) | Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Percentage of participants achieving ≥ 50% improvement in mSWAT of at least 28-days duration |
| Secondary | Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 28 Days | 28 days after first dose | Percentage of subjects achieving ≥ 50% improvement from baseline in mSWAT at 28 days after first dose |
| Secondary | Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 4 Months | 4 months after first dose | Percentage of subjects achieving ≥ 50% improvement from baseline in mSWAT at 4 months after first dose |
| Secondary | Time to ≥ 50% Improvement in mSWAT | Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Time from date of randomization until ≥ 50% improvement in mSWAT score |
| Secondary | Duration of Response in Skin | Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Duration of response in skin (no progression after achieving ≥ 50% improvement in mSWAT) |
| Secondary | Pruritus Medication Utilization | Date of first dose through end of treatment or interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Change from baseline in number of pruritus medications taken per subject |
| Other | Peak Plasma Concentration (Cmax) of Cobomarsen - First Dose | 1, 1.92, 6, 24 and 48 hours post-dose after the first dose | Peak plasma concentration (Cmax) of cobomarsen after first dose |
| Other | Peak Plasma Concentration (Cmax) of Cobomarsen - Week 5 | 1, 1.92 and 6 hours post-dose after the Week 5 dose | Peak plasma concentration (Cmax) of cobomarsen after fourth dose (Week 5) |
| Other | Area Under the Plasma Concentration vs. Time Curve (AUC) of Cobomarsen - Week 5 | 1, 1.92 and 6 hours post-dose after the Week 5 dose | Area under the curve (AUClast) for cobomarsen plasma concentration versus time curve after the fourth (Week 5) dose |
| Other | Number of Participants With Anti-drug Antibody Generation | Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Number of participants who develop antibodies to cobomarsen during treatment |
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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GET https://conductscience.org/api/trials/v1/NCT03713320/registered