Phase 2 N=194 Randomized Triple-blind Treatment

A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa

Acne Inversa

Bottom Line

View on ClinicalTrials.gov: NCT04092452 ↗

Enrolled (actual)

194

Serious AEs

2.1%

Results posted

Jun 2023

Primary outcome: Primary: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)]. — 33.3; 34.0; 51.9; 37.0 Percentage of participants — p=0.4696

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: PF-06650833 (Drug); PF-06700841 (Drug); PF-06826647 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)].	33.3; 34.0; 51.9; 37.0	0.4696
SECONDARY Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI).	16.7; 12.8; 15.4; 21.3; 25.0; 31.9	0.7798
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).	16.7; 17.0; 28.8; 23.9; 22.9; 27.7	0.5150
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)].	-1.94; -13.92; -17.00; -19.39; -22.29; -34.81	0.8108
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).	22.9; 21.4; 20.8; 21.4; 18.9; 18.0	0.6393
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).	-7.26; -10.91; -21.02; -24.77; -26.58; -30.87	0.7000
SECONDARY Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)].	13.3; 11.9; 4.8; 14.3; 9.3; 15.4	0.8372
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)	7.3; 18.9; 16.7; 19.5; 17.1; 21.6	0.0559
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)	10.3; 17.6; 24.4; 8.6; 17.9; 20.6	0.1687
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)	-1.45; -8.89; -11.97; -15.58; -7.49; -13.15	0.1321
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)	-2.47; -8.64; -13.53; -8.81; -11.24; -13.39	0.1505
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)	-0.23; -0.54; -0.68; -0.71; -0.52; -0.84	0.1536
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)	-0.19; -0.44; -0.62; -0.50; -0.49; -0.77	0.1898
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)	6.5; 4.7; 8.7; 13.6; 10.9; 20.9	0.1162
SECONDARY Number of Participants With Treatment-Emergent Adverse Events (All Causalities)	23; 26; 30; 29; 0; 2	—
SECONDARY Number of Participants With Treatment-Emergent Adverse Events (Treatment Related)	7; 10; 12; 16; 0; 1	—
SECONDARY Number of Participants With Incidence of Post-baseline Vital Signs of Clinical Concern - Increase From Baseline (Safety Analysis Set)	2; 1; 2; 4; 1; 1	—
SECONDARY Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set)	1; 0; 4; 0; 0; 0	—
SECONDARY Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set)	0; 0; 0; 0; 2; 0	—
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)	5.67; 5.47; 5.19; 5.25; 5.39; 5.10	—
SECONDARY Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS)	-0.19; -0.39; -0.67; -0.61; -0.47; -0.77	—
SECONDARY Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS)	10.2; 10.6; 9.6; 11.1; 10.8; 10.2	—
SECONDARY Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS)	-5.5; -5.1; -6.1; -4.6; -4.9; -5.5	—
SECONDARY Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI)	6.8; 6.8; 8.9; 2.3; 2.2; 6.8	—
SECONDARY Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set)	31.79; 49.22; 281.7; 30.48; 51.48; 263.8	—

Summary

This is a study with 3 kinase inhibitors (PF 06650833, PF 06700841 and PF 06826647) in participants with moderate to severe HS. The study will have a maximum duration of approximately 26 weeks. This includes an up to 6-week Screening Period, a 16 week Dosing Period and a 4 week Follow up Period.

Eligibility Criteria

Inclusion Criteria

male or female participants, between 18-75, with a diagnosis of moderate to severe Hidradenitis Suppurativa

Exclusion Criteria

History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
Infected with hepatitis B or hepatitis C viruses.
Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04092452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.