Trial · NCT04092452
A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa
NCT04092452, Phase 2, Completed, Pfizer; results first posted 2023-06-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa. Trials, record NCT04092452. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04092452
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa
- NCT number
- NCT04092452
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 194 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Acne Inversa
- Interventions
- PF-06650833, PF-06700841, PF-06826647, Placebo
- First posted
- 2019-09-17
- Last updated
- 2023-06-15
- Results first posted
- 2023-06-15
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | HiSCR response was defined as at least a 50% reduction in total abscess and inflammatory nodule (AN) count relative to baseline, and no increase in abscess count, and no increase in draining fistula count. Confidence interval (CI) was calculated using Blyth-Still-Casella method. |
| 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 | HiSCR response was defined as at least a 50% reduction in total abscess and inflammatory nodule (AN) count relative to baseline, and no increase in abscess count, and no increase in draining fistula count. Confidence interval (CI) was calculated using Blyth-Still-Casella method. |
| 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 | This estimand was intended to provide difference between treated and placebo in percentage of participants with a total AN count of 0 or 1, or 0, 1 or 2, respectively at week 16. Confidence interval (CI) was calculated using Blyth-Still-Casella method. |
| 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 | The analysis of covariance (ANCOVA) model was implemented for statistical testing, which included terms of treatment group, the stratification factors, and the baseline value as the independent variable. |
| 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 | The IHS4 score was calculated by the number of nodules, the number of abscesses, and the number of draining tunnels. IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + {number of draining tunnels (fistulae/sinuses) × 4}. Confidence interval (CI) was calculated using Blyth-Still-Casella method. Lower IHS4 absolute scores mean a better outcome. |
| 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 | The IHS4 score was calculated by the number of nodules, the number of abscesses, and the number of draining tunnels. IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + {number of draining tunnels (fistulae/sinuses) × 4}. Confidence interval (CI) was calculated using Blyth-Still-Casella method. Lower IHS4 absolute scores mean a better outcome. |
| 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 | HS flare was defined as at least a 25% increase in AN count with a minimum increase of 2 relative to Baseline. Confidence interval (CI) was calculated using Blyth-Still-Casella method. |
| 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 | The rate comparing treatment and placebo groups at each visit was analyzed using CMH test with MR weighting strategy between each of active treatment group and placebo. Confidence interval (CI) was calculated using Blyth-Still-Casella method. NRS30 was defined as ≥30% reduction and ≥1 unit reduction from baseline in Patient's Global Assessment (PGA) Skin Pain NRS. The range of skin pain was from 0 to 10. Lower IHS4 absolute scores mean a better outcome. Baseline was defined as the average of all values recorded between Day -6 and Day 1. Weekly data were average values of daily observations over 7 days. NRI (non-responder imputation) for missing values which were related to withdrawal and all other events except for COVID-19. |
| 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 | The rate comparing treatment and placebo groups at each visit was analyzed using CMH test with MR weighting strategy between each of active treatment group and placebo. Confidence interval (CI) was calculated using Blyth-Still-Casella method. NRS30 was defined as ≥30% reduction and ≥1 unit reduction from baseline in Patient's Global Assessment (PGA) Skin Pain NRS. The range of skin pain was from 0 to 10. Lower IHS4 absolute scores mean a better outcome. Baseline was defined as the average of all values recorded between Day -6 and Day 1. Weekly data were average values of daily observations over 7 days. NRI (non-responder imputation) for missing values which were related to withdrawal and all other events except for COVID-19. |
| 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 | Patient Global Assessment Skin Pain Numeric Rating Scale was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). These two concepts were measured within the same instrument, but were scored separately. There was no composite score for this endpoint. The higher the score, the worse the outcomes, ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Subscales were not combined. The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group1,077
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)]. | Placebo | 33.3 | 90% Confidence Interval 22.2 to 45.5 | Percentage of participants | |
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)]. | PF-06650833 400mg QD | 34.0 | 90% Confidence Interval 22.7 to 46.5 | Percentage of participants | |
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)]. | PF-06700841 45mg QD | 51.9 | 90% Confidence Interval 39.7 to 64.0 | Percentage of participants | |
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)]. | PF-06826647 400mg QD | 37.0 | 90% Confidence Interval 25.5 to 50.0 | Percentage of participants | |
| Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Placebo | Week 1 | 16.7 | 90% Confidence Interval 8.6 to 27.7 | Percentage of participants |
| Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | PF-06650833 400mg QD | Week 1 | 12.8 | 90% Confidence Interval 5.7 to 22.7 | Percentage of participants |
| Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | PF-06700841 45mg QD | Week 1 | 15.4 | 90% Confidence Interval 7.9 to 25.4 | Percentage of participants |
| Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | PF-06826647 400mg QD | Week 1 | 21.3 | 90% Confidence Interval 12.0 to 32.2 | Percentage of participants |
| Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Placebo | Week 2 | 25.0 | 90% Confidence Interval 15.1 to 36.9 | Percentage of participants |
| Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | PF-06650833 400mg QD | Week 2 | 31.9 | 90% Confidence Interval 20.8 to 44.4 | Percentage of participants |
1 to 10 of 1,077Source ClinicalTrials.gov
See all 1,077 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 48 | |
| Overall Study | STARTED | PF-06650833 400mg QD | 47 | |
| Overall Study | STARTED | PF-06700841 45mg QD | 52 | |
| Overall Study | STARTED | PF-06826647 400mg QD | 47 | |
| Overall Study | COMPLETED | Placebo | 35 | |
| Overall Study | COMPLETED | PF-06650833 400mg QD | 30 | |
| Overall Study | COMPLETED | PF-06700841 45mg QD | 37 | |
| Overall Study | COMPLETED | PF-06826647 400mg QD | 31 | |
| Overall Study | NOT COMPLETED | Placebo | 13 | |
| Overall Study | NOT COMPLETED | PF-06650833 400mg QD | 17 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 48 | |
| other | Nausea | Gastrointestinal disorders | PF-06650833 400mg QD | 1 | 47 | |
| other | Nausea | Gastrointestinal disorders | PF-06700841 45mg QD | 1 | 52 | |
| other | Nausea | Gastrointestinal disorders | PF-06826647 400mg QD | 3 | 47 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 1 | 48 | |
| other | Urinary tract infection | Infections and infestations | PF-06650833 400mg QD | 3 | 47 | |
| other | Urinary tract infection | Infections and infestations | PF-06700841 45mg QD | 2 | 52 | |
| other | Urinary tract infection | Infections and infestations | PF-06826647 400mg QD | 0 | 47 | |
| other | Blood creatine phosphokinase increased | Investigations | Placebo | 0 | 48 | |
| other | Blood creatine phosphokinase increased | Investigations | PF-06650833 400mg QD | 0 | 47 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 48 |
| Total, all-cause mortality | PF-06650833 400mg QD | 0 | 47 |
| Total, all-cause mortality | PF-06700841 45mg QD | 0 | 52 |
| Total, all-cause mortality | PF-06826647 400mg QD | 0 | 47 |
| Total, other adverse events | Placebo | 6 | 48 |
| Total, other adverse events | PF-06650833 400mg QD | 10 | 47 |
| Total, other adverse events | PF-06700841 45mg QD | 14 | 52 |
| Total, other adverse events | PF-06826647 400mg QD | 18 | 47 |
| Total, serious adverse events | Placebo | 0 | 48 |
| Total, serious adverse events | PF-06650833 400mg QD | 2 | 47 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38335032 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04092452
GET https://conductscience.org/api/trials/v1/NCT04092452/registered?page=2