Trial · NCT04206553
Registered outcomes49
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 49
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Participants Achieving Sustained Remission at Week 36 | At Week 36 | Sustained remission at week 36, defined as: (1) Complete remission (absence of new lesions \& epithelialization of old lesions) \& off oral corticosteroids (OCS) no later than week 16 \& (2) Absence of disease relapse (appearance of ≥3 new lesions a month \[blisters, eczematous lesions, or urticarial plaques\] or at least 1 large eczematous lesion or urticarial plaque that does not heal within 1 week) after completion of OCS taper, no later than week 16, to week 36 \& (3) Absence of need for rescue therapy during 36 weeks (rescue therapy includes increase of OCS dose during the taper, re-initiation of OCS after completion of the OCS taper, or initiation of any BP-directed therapy). Participants with missing sustained remission data at week 36 due to discontinuation due to lack of efficacy, treatment-related AE, or death were considered non-responders \& those with missing data due to other reasons were handled using multiple imputation. |
| Secondary | Total Cumulative Dose of Oral Corticosteroids (OCS) From Baseline to Week 36 | Week 36 | All participants in both treatment groups were started on OCS at randomization (day 1) with taper beginning no later than week 6 with the objective to taper off by week 16. OCS could be used as rescue treatment for loss of disease control/ disease relapse during the study. Days after non-OCS systemic rescue treatment use were imputed by the worst observation carried forward (WOCF) method (i.e., the highest daily OCS dose prior to any non-OCS systemic rescue treatment use). Missing data after study discontinuation were imputed with the average daily OCS dose among week 36 completers in each treatment group. |
| Secondary | Percent Change in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 36 | Baseline, Week 36 | Peak pruritus NRS was used by participants to rate the intensity of pruritus during the past 24 hours, with 0 indicating no itch and 10 indicating worst itch possible. Participants were required to have a baseline peak pruritus NRS maximum intensity average of ≥4 during the 7 days prior to randomization for eligibility. Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 36. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation. |
| Secondary | Percent of Participants With Improvement (Reduction) of Weekly Average of Daily Peak Pruritus NRS ≥4 From Baseline to Week 36 | Baseline, Week 36 | Peak pruritus NRS was used by participants to rate the intensity of pruritus during the past 24 hours, with 0 indicating no itch and 10 indicating worst itch possible. Participants were required to have a baseline peak pruritus NRS maximum intensity average of ≥4 during the 7 days prior to randomization for eligibility. Participants were considered non-responders after rescue treatment use. Participants with missing values caused by discontinuation from the study before week 36 due to lack of efficacy, treatment-related AE, or death were considered non-responders. Missing values due to other reasons were imputed using multiple imputation of the continuous data of the weekly average of daily peak pruritus NRS. |
| Secondary | Percent Change in Bullous Pemphigoid Disease Area Index (BPDAI) Activity Score From Baseline to Week 36 | Baseline, Week 36 | BPDAI activity score is the arithmetic sum of 3 subcomponents: cutaneous blisters/erosions, cutaneous urticaria/erythema, and mucosal blisters/erosions. Scores can range from 0 to 360 for BPDAI total activity (maximum 240 for total skin activity and 120 for mucosal activity), with higher scores indicating greater disease activity. Participants were required to have a BPDAI activity score of ≥24 at the screening and baseline visits for eligibility. Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 36. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation. |
| Secondary | Time to First Use of Rescue Medication Up to Week 36 | Up to Week 36 | Participants were considered to have used rescue treatment at the time of discontinuation from the study due to lack of efficacy, treatment-related AE, or death. Participants were censored at the time of discontinuation from the study due to other reasons. Restricted mean event time and corresponding standard error (SE) are based on the Kaplan-Meier method. The restricted mean event time was calculated up to study day 253 (i.e., week 36). |
| Secondary | Duration of Complete Remission While Not Requiring OCS Up to Week 36 | Up to Week 36 | Complete remission was defined as absence of new lesions and epithelialization of old lesions. Participants were considered as not achieving complete remission after rescue treatment use. Participants with missing assessment of complete remission caused by discontinuation from the study before week 36 due to lack of efficacy, treatment-related AE, or death were considered as not achieving complete remission. Participants with missing assessment of complete remission due to other reasons were imputed using multiple imputation. |
| Secondary | Percent of Participants Who Did Not Achieve Control of Disease Activity Before Week 36 | Up to Week 36 | Control of disease activity was defined as absence of new lesions and existing lesions beginning to heal. Participants who achieved initial control of disease activity after rescue treatment use were considered to not have achieved control of disease activity before week 36. Participants whose response status could not be determined due to missing data were considered to not have achieved control of disease activity before week 36. |
| Secondary | Percent of Participants Who Relapsed After Achieving Control of Disease Activity Up to Week 36 | Up to Week 36 | Relapse was defined as the appearance of 3 or more new lesions a month (blisters, eczematous lesions, or urticarial plaques) or at least 1 large (\>10 centimeters \[cm\] diameter) eczematous lesion or urticarial plaque that does not heal within 1 week. Control of disease activity was defined as absence of new lesions and existing lesions beginning to heal. Participants who used rescue treatment were considered to have relapsed after achieving control of disease activity. Participants whose response status could not be determined due to missing data were considered to have relapsed after achieving control of disease activity. |
| Secondary | Percent of Participants Who Did Not Achieve Complete Remission Before Week 36 | Up to Week 36 | Complete remission was defined as absence of new lesions and epithelialization of old lesions. Participants who achieved initial complete remission after rescue treatment use were considered to not have achieved complete remission before week 36. Participants whose response status could not be determined due to missing data were considered to not have achieved complete remission before week 36. |
| Secondary | Percent of Participants Achieving a Reduction in BPDAI Activity Score of ≥50% From Baseline to Week 36 | Baseline, Week 36 | BPDAI activity score is the arithmetic sum of 3 subcomponents: cutaneous blisters/erosions, cutaneous urticaria/erythema, and mucosal blisters/erosions. Scores can range from 0 to 360 for BPDAI total activity (maximum 240 for total skin activity and 120 for mucosal activity), with higher scores indicating greater disease activity. Participants were required to have a BPDAI activity score of ≥24 at the screening and baseline visits for eligibility. Participants were considered non-responders after rescue treatment use. Participants with missing values caused by discontinuation from the study before week 36 due to lack of efficacy, treatment-related AE, or death were considered non-responders. Missing values due to other reasons were imputed using multiple imputation of the continuous data of the BPDAI activity score. |
| Secondary | Percent of Participants Achieving a Reduction in BPDAI Activity Score of ≥75% From Baseline to Week 36 | Baseline, Week 36 | BPDAI activity score is the arithmetic sum of 3 subcomponents: cutaneous blisters/erosions, cutaneous urticaria/erythema, and mucosal blisters/erosions. Scores can range from 0 to 360 for BPDAI total activity (maximum 240 for total skin activity and 120 for mucosal activity), with higher scores indicating greater disease activity. Participants were required to have a BPDAI activity score of ≥24 at the screening and baseline visits for eligibility. Participants were considered non-responders after rescue treatment use. Participants with missing values caused by discontinuation from the study before week 36 due to lack of efficacy, treatment-related AE, or death were considered non-responders. Missing values due to other reasons were imputed using multiple imputation of the continuous data of the BPDAI activity score. |
| Secondary | Percent of Participants Achieving a Reduction in BPDAI Activity Score of ≥90% From Baseline to Week 36 | Baseline, Week 36 | BPDAI activity score is the arithmetic sum of 3 subcomponents: cutaneous blisters/erosions, cutaneous urticaria/erythema, and mucosal blisters/erosions. Scores can range from 0 to 360 for BPDAI total activity (maximum 240 for total skin activity and 120 for mucosal activity), with higher scores indicating greater disease activity. Participants were required to have a BPDAI activity score of ≥24 at the screening and baseline visits for eligibility. Participants were considered non-responders after rescue treatment use. Participants with missing values caused by discontinuation from the study before week 36 due to lack of efficacy, treatment-related AE, or death were considered non-responders. Missing values due to other reasons were imputed using multiple imputation of the continuous data of the BPDAI activity score. |
| Secondary | Change in Autoimmune Bullous Disease Quality of Life (ABQOL) Score From Baseline to Week 36 | Baseline, Week 36 | ABQOL questionnaire consists of 17 items, which encompass physical burden of the disease, psychiatric effects, and effects on daily life functioning. Each question ranges from 0 to 3 points, with higher scores indicating poorer quality of life. The maximum ABQOL score is 51. Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 36. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation. |
| Secondary | Change in Percent Body Surface Area (BSA) of BP Involvement From Baseline to Week 36 | Baseline, Week 36 | Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 36. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation. |
| Secondary | Change in BP180 Immunoglobulin G (IgG) Autoantibody Titer From Baseline to Week 36 | Baseline, Week 36 | Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 36. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation. |
| Secondary | Change in BP230 IgG Autoantibody Titer From Baseline to Week 36 | Baseline, Week 36 | Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 36. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation. |
| Secondary | Percent of Participants Achieving Sustained Remission at Week 52 | At Week 52 | Sustained remission at week 52, defined as: (1) Complete remission (absence of new lesions \& epithelialization of old lesions) \& off OCS no later than week 16 \& (2) Absence of disease relapse (appearance of ≥3 new lesions a month \[blisters, eczematous lesions, or urticarial plaques\] or at least 1 large eczematous lesion or urticarial plaque that does not heal within 1 week) after completion of OCS taper, no later than week 16, to week 52 \& (3) Absence of need for rescue therapy during 52 weeks (rescue therapy includes increase of OCS dose during the taper, re-initiation of OCS after completion of the OCS taper, or initiation of any BP-directed therapy). Participants with missing sustained remission data at week 52 due to discontinuation due to lack of efficacy, treatment-related AE, or death were considered non-responders \& those with missing data due to other reasons were handled using multiple imputation. |
| Secondary | Total Cumulative Dose of OCS From Baseline to Week 52 | Week 52 | All participants in both treatment groups were started on OCS at randomization (day 1) with taper beginning no later than week 6 with the objective to taper off by week 16. OCS could be used as rescue treatment for loss of disease control/ disease relapse during the study. Days after non-OCS systemic rescue treatment use were imputed by the WOCF method (i.e., the highest daily OCS dose prior to any non-OCS systemic rescue treatment use). Missing data after study discontinuation were imputed with the average daily OCS dose among week 52 completers in each treatment group. |
| Secondary | Duration of Complete Remission While Not Requiring OCS Up to Week 52 | Up to Week 52 | Complete remission was defined as absence of new lesions and epithelialization of old lesions. Participants were considered as not achieving complete remission after rescue treatment use. Participants with missing assessment of complete remission caused by discontinuation from the study before week 52 due to lack of efficacy, treatment-related AE, or death were considered as not achieving complete remission. Participants with missing assessment of complete remission due to other reasons were imputed using multiple imputation. |
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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