Trial · NCT04092452
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)]. | At week 16 | All participants randomized and received at least one dose of study intervention. One participant in the PF-06826647 group with missing data due to COVID-19 was excluded from the main analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | At weeks 1, 2, 4, 6, 8, and 12 | All participants randomized and received at least one dose of study intervention. One participant in the PF-06826647 group with missing data due to COVID-19 was excluded from the main analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Total Abscess and Inflammatory Nodule (AN) Count of 0 or 1; 0, 1 or 2 at Week 16 - MR (FAS, NRI). | At week 16 | All participants randomized and received at least one dose of study intervention. In PF-06826647 400mg QD treatment group, 1 participant discontinued the study due to COVID-19 pandemic during study Days 9 - 16. Based on the pre-specification in the statistical analysis plan (SAP), this participant was excluded from the analysis after the treatment discontinuation visit. | Percentage of participants | NUMBER |
| SECONDARY | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | At weeks 1, 2, 4, 6, 8, 12 and 16 | All participants randomized and received at least one dose of study intervention. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | At weeks 1, 2, 4, 6, 8, 12 and 16 | All participants randomized and received at least one dose of study intervention. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | At weeks 1, 2, 4, 6, 8, 12 and 16 | All participants randomized and received at least one dose of study intervention. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)]. | At weeks 4, 8, 12 and 16 | All participants randomized and received at least one dose of study intervention. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | At weeks 1, 2, 4, 6, 8, 12 and 16 | All participants randomized and received at least one dose of study intervention with baseline NRS≥3 scores. One participant in the PF-06826647 group with missing data due to COVID-19 was excluded from the main analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | At weeks 1, 2, 4, 6, 8, 12 and 16 | All participants randomized and received at least one dose of study intervention with baseline NRS≥3 scores. One participant in the PF-06826647 group with missing data due to COVID-19 was excluded from the main analysis. | Percentage of participants | NUMBER |
| SECONDARY | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | At weeks 1, 2, 4, 6, 8, 12 and 16 | All participants randomized and received at least one dose of study intervention with baseline ≥3 scores were included. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | At weeks 1, 2, 4, 6, 8, 12 and 16 | All participants randomized and received at least one dose of study intervention with baseline ≥3 scores were included. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | At weeks 1, 2, 4, 6, 8, 12 and 16 | All participants randomized and received at least one dose of study intervention. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | At weeks 1, 2, 4, 6, 8, 12 and 16 | All participants randomized and received at least one dose of study intervention. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | At weeks 1, 2, 4, 6, 8, 12 and 16 | All participants randomized and received at least one dose of study intervention with baseline erythema score ≥2 scores in at least 1 region were included. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Up to 20 weeks | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Up to 20 weeks | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Incidence of Post-baseline Vital Signs of Clinical Concern - Increase From Baseline (Safety Analysis Set) | Up to 20 weeks | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Up to 20 weeks | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | Up to 20 weeks | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention with post-baseline result. If participants didn't have any post-baseline measurement, the participants were not included in the denominator. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | At weeks 1, 2, 4, 6, 8, 12 and 16 | All participants randomized and received at least one dose of study intervention. | Units on a scale | LEAST_SQUARES_MEAN |
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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