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NCT03569371

A Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa

Completed Phase 2 Results posted Last updated 26 September 2022
What this trial tests

Phase 2 trial testing INCB054707 in Hidradenitis Suppurativa in 10 participants. Completed in 22 April 2019.

Timeline
17 July 2018
Primary endpoint
22 April 2019
22 April 2019

Quick facts

Lead sponsorIncyte Corporation
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date17 July 2018
Primary completion22 April 2019
Estimated completion22 April 2019
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Incyte Corporation — full company profile →

Who can join

Adults 18 to 75, any sex, with Hidradenitis Suppurativa. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Primary · Up to approximately 12 weeks.

A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.

GroupValue95% CI
INCB0547077
Apparent Oral Clearance of INCB054707(CL/F) Secondary · Postdose Day1, week 2 and 6

To evaluate the systemic exposure to INCB054707.

GroupValue95% CI
INCB0547075.07± 24.3
Apparent Oral Volume of Distribution of INCB054707(Vc/F) Secondary · Postdose Day1, week 2 and 6.

To evaluate the systemic exposure to INCB054707.

GroupValue95% CI
INCB054707227± 39.9
Absorption Constant of INCB054707 (Ka) Secondary · Postdose Day1, week 2 and 6.

Other population pharmacokinetic (PK) model parameter that the PK model may include to evaluate the systemic exposure to INCB054707.

GroupValue95% CI
INCB0547070.257± 15.2
Apparent Inter-compartmental Clearance(Q/F) Secondary · Postdose Day1, week 2 and 6.

Other population PK model parameter that the PK model may include to evaluate the systemic exposure to INCB054707.

GroupValue95% CI
INCB05470716.2± 13.4
Proportion of Participants With a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit Secondary · Weeks 1,2,4,6,8 and FollowUp

An HiSCR is defined as at least 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline at each visit.

Week 1
GroupValue95% CI
INCB0547071
Week 2
GroupValue95% CI
INCB0547073
Week 4
GroupValue95% CI
INCB0547073
Week 6
GroupValue95% CI
INCB0547072
Week 8
GroupValue95% CI
INCB0547073
Follow Up
GroupValue95% CI
INCB0547074
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit Secondary · Weeks 1,2,4,6,8 and FollowUp

The number and proportion of participants who achieved an Abscess and Inflammatory nodule count of 0 to 2 progressively.

Baseline
GroupValue95% CI
INCB0547070
Week 1
GroupValue95% CI
INCB0547072
Week 2
GroupValue95% CI
INCB0547074
Week 4
GroupValue95% CI
INCB0547074
Week 6
GroupValue95% CI
INCB0547072
Week 8
GroupValue95% CI
INCB0547073
Follow Up
GroupValue95% CI
INCB0547074
Mean Change From Baseline in the HS Pain Numeric Rating Scale (NRS) Scores at Each Visit Secondary · Weeks 1,2,4,6,8 and FollowUp

The HS Pain NRS will be completed in a daily diary by participants from screening through EOS. An 11-point scale will be used to assess the worst skin pain due to HS based on a recall period of the last 24 hours. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine)

Week 1
GroupValue95% CI
INCB054707-1.5± 1.9
Week 2
GroupValue95% CI
INCB054707-3.2± 2.9
Week 4
GroupValue95% CI
INCB054707-2.6± 2.9
Week 6
GroupValue95% CI
INCB054707-3.2± 3.2
Week 8
GroupValue95% CI
INCB054707-2.0± 1.8
Follow Up
GroupValue95% CI
INCB054707-1.8± 1.6
Mean Change From Baseline in the Modified Sartorius Scale Score Secondary · Week 8.

The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other). For each area, points are awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated buy normal skin (yes-0 point; no-6 points). The total Sartorius Scale score is the sum of th

GroupValue95% CI
INCB054707-13.6± 21.3
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit Secondary · Up to approximately 12 weeks.

Draining fistulas are fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.

Week 1
GroupValue95% CI
INCB054707-0.1± 0.6
Week 2
GroupValue95% CI
INCB0547070.2± 0.4
Week 4
GroupValue95% CI
INCB0547070.6± 1.7
Week 6
GroupValue95% CI
INCB0547071.9± 2.9
Week 8
GroupValue95% CI
INCB0547070.1± 1.1
Follow Up
GroupValue95% CI
INCB0547070.7± 2.4
Proportion of Participants at Each Category of Hurley Stage Secondary · Baseline and Week 8.

The Hurley classification is a static score and was originally designed for selection of the appropriate treatment modality in a certain body region. The assessor determines the Hurley stage in each affected anatomical region. If more than 1 stage is present in the same region, the worst stage in that region is documented. The participant will be assigned an overall Hurley stage classification corresponding to the stage of the worst involved anatomical region. The definition of each Hurley stage is as follows: Stage I : Abscess formation, single or multiple, without sinus tracts and cicatriza

Baseline
GroupValue95% CI
INCB0547070
INCB0547077
INCB0547073
INCB0547070
Week 8
GroupValue95% CI
INCB0547070
INCB0547075
INCB0547071
INCB0547071
Proportion of Participants With Change From Baseline to Week 8 in Hurley Stage Secondary · Week 8.

The Hurley classification is a static score and was originally designed for selection of the appropriate treatment modality in a certain body region. The assessor determines the Hurley stage in each affected anatomical region. If more than 1 stage is present in the same region, the worst stage in that region is documented. The participant will be assigned an overall Hurley stage classification corresponding to the stage of the worst involved anatomical region. The definition of each Hurley stage is as follows: Stage I : Abscess formation, single or multiple, without sinus tracts and cicatriza

Baseline
GroupValue95% CI
INCB0547070
INCB0547070
INCB0547077
INCB0547073
Week 8
GroupValue95% CI
INCB0547071
INCB0547070
INCB0547075
INCB0547071

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to approximately 12 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

INCB054707
Serious: 0/10 (0%)
Deaths: 0/10
Other adverse events (7 terms — click to expand)

ReactionSystemINCB054707
Upper respiratory tract infectionInfections and infestations—
NauseaGastrointestinal disorders—
FibromyalgiaMusculoskeletal and connective tissue disorders—
HeadacheNervous system disorders—
AnxietyPsychiatric disorders—
Night sweatsSkin and subcutaneous tissue disorders—
RashSkin and subcutaneous tissue disorders—

Data from ClinicalTrials.gov NCT03569371 adverse events section.

Sponsor's own description

The purpose of this study is to assess the safety of INCB054707 in men and women with moderate to severe hidradenitis suppurativa (HS).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Emerging Topical and Systemic JAK Inhibitors in Dermatology.
    Solimani F, Meier K, Ghoreschi K. · · 2019 · cited 199× · PMID 31849996 · DOI 10.3389/fimmu.2019.02847
  2. Targeting the Janus Kinase Family in Autoimmune Skin Diseases.
    Howell MD, Kuo FI, Smith PA. · · 2019 · cited 180× · PMID 31649667 · DOI 10.3389/fimmu.2019.02342
  3. Janus kinase 1 inhibitor INCB054707 for patients with moderate-to-severe hidradenitis suppurativa: results from two phase II studies.
    Alavi A, Hamzavi I, Brown K, Santos LL, et al · · 2022 · cited 61× · PMID 34978076 · DOI 10.1111/bjd.20969
  4. Cytokine Pathways and Investigational Target Therapies in Hidradenitis Suppurativa.
    Del Duca E, Morelli P, Bennardo L, Di Raimondo C, et al · · 2020 · cited 52× · PMID 33182701 · DOI 10.3390/ijms21228436
  5. Selective Janus Kinase 1 Inhibition Is a Promising Therapeutic Approach for Lupus Erythematosus Skin Lesions.
    Fetter T, Smith P, Guel T, Braegelmann C, et al · · 2020 · cited 48× · PMID 32194562 · DOI 10.3389/fimmu.2020.00344
  6. New perspectives on the treatment of hidradenitis suppurativa.
    Amat-Samaranch V, Agut-Busquet E, Vilarrasa E, Puig L. · · 2021 · cited 47× · PMID 34840709 · DOI 10.1177/20406223211055920
  7. New and Emerging Targeted Therapies for Hidradenitis Suppurativa.
    Markota Čagalj A, Marinović B, Bukvić Mokos Z. · · 2022 · cited 46× · PMID 35409118 · DOI 10.3390/ijms23073753
  8. Clinical Implementation of Biologics and Small Molecules in the Treatment of Hidradenitis Suppurativa.
    Aarts P, Dudink K, Vossen ARJV, van Straalen KR, et al · · 2021 · cited 38× · PMID 34283386 · DOI 10.1007/s40265-021-01566-2

Verify or expand the search:

Other trials of INCB054707

Trials testing the same drug.

Other recruiting trials for Hidradenitis Suppurativa

Currently open trials in the same condition.

Other Incyte Corporation trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing