INCB054707 for Hidradenitis Suppurativa

No longer recruiting at 44 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Incyte Corporation

Must not be taking: JAK inhibitors

Disqualifiers: Pregnancy, Cancer, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called INCB054707 for individuals with hidradenitis suppurativa, a skin condition that causes painful lumps under the skin. The study aims to assess the safety and effectiveness of this treatment over several weeks. Initially, some participants receive a placebo (a substance with no active drug) before all receive the actual treatment. Participants will try different doses to determine the most effective one. Individuals with active hidradenitis suppurativa for at least three months, affecting two or more areas, might be suitable candidates. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that INCB054707 has been tested in people before. In one study, 70% of participants experienced side effects. Another study found that 81% had at least one side effect. Common side effects included infections, but serious ones like sepsis and abscesses were rare and improved with treatment.

These findings suggest that while side effects are common, they are usually not severe. The treatment remains under study to ensure safety, so new information may emerge. Prospective trial participants should discuss these side effects with a doctor to make an informed decision. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hidradenitis suppurativa?

Unlike the standard treatments for Hidradenitis Suppurativa, which often include antibiotics, corticosteroids, or biologics like TNF inhibitors, INCB054707 offers a novel approach by targeting the JAK1 enzyme. This mechanism of action is different from existing treatments, potentially reducing inflammation more effectively. Researchers are excited about INCB054707 because it could offer better symptom management and improved quality of life for patients, especially in cases where current treatments fail to provide relief. Additionally, the option for open-label extension suggests a longer-term benefit, allowing patients to continue treatment beyond the initial trial period.

What evidence suggests that this trial's treatments could be effective for hidradenitis suppurativa?

Research has shown that INCB054707, a type of medication, may help treat hidradenitis suppurativa (HS), a skin condition. In studies, patients with moderate-to-severe HS experienced positive results with this treatment. Participants in this trial will receive different dosages of INCB054707, including 15 mg, 45 mg, and 75 mg, or a placebo followed by INCB054707 75 mg. Most participants in previous studies completed a 16-week trial and experienced noticeable improvements. The treatment was also well-tolerated by those who took it. These findings suggest that INCB054707 could effectively manage HS symptoms. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

You have been experiencing symptoms of HS disease for at least 3 months before the screening.

HS disease duration of at least 3 months before screening

Participants agree NOT to use topical antiseptics on the areas affected by HS lesions during the placebo-controlled 16-week treatment period

Exclusion Criteria

Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis

Participants known to be infected with HIV, Hepatitis B, or Hepatitis C

You have tried using JAK inhibitors before to treat inflammatory diseases, but they didn't work for you.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INCB054707 or placebo for 16 weeks in a placebo-controlled treatment period

16 weeks

Visits at Weeks 2, 4, 6, 8, 12, and 16

Open-label Extension

Participants receive INCB054707 75 mg for 36 weeks

36 weeks

Long-term Extension

Participants may opt into continuation of open-label treatment for an additional 48 weeks

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• INCB054707

How Is the Trial Designed?

Group I: INCB054707 75 mg Experimental Treatment 1 Intervention

Participants will receive INCB054707 75 mg for 52 weeks in the Placebo-controlled Treatment Period (16 weeks) plus the Open-label Extension Period (36 weeks). Participants will have the option to continue open-label treatment for an additional 48 weeks.

Group II: INCB054707 45 mg Experimental Treatment 1 Intervention

Participants will receive INCB054707 45 mg for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.

Group III: INCB054707 15 mg Experimental Treatment 1 Intervention

Participants will receive INCB054707 15 milligrams (mg) for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.

Group IV: Placebo followed by INCB054707 75 mg Placebo Group 1 Intervention

Participants will receive placebo for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34978076/

Janus kinase 1 inhibitor INCB054707 for patients with ... INCB054707 was well tolerated, with responses observed in patients with moderate-to-severe HS. The safety and efficacy findings from these studies demonstrate ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04476043?term=AREA%5BBasicSearch%5D(012%20402)&rank=1

To Assess the Efficacy and Safety of INCB054707 in ... To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis suppurativa over a 16-week placebo-controlled treatment period followed ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37871805/

Efficacy and safety of the oral Janus kinase 1 inhibitor ... Results: Of 209 patients randomized (15 mg, n = 52; 45 mg, n = 52; 75 mg, n = 53; placebo, n = 52), 83.3% completed the 16-week treatment. At ...

4. jaad.org jaad.org/article/S0190-9622(23)03037-2/fulltext

Efficacy and safety of the oral Janus kinase 1 inhibitor ... This placebo-controlled phase 2 study randomized patients with HS 1:1:1:1 to receive povorcitinib 15, 45, or 75 mg or placebo for 16 weeks.

5. investor.incyte.com investor.incyte.com/news-releases/news-release-details/incyte-announces-positive-topline-results-two-phase-3-clinical

Incyte Announces Positive Topline Results From Two ... "The positive Phase 3 data highlights the potential of povorcitinib as an effective oral treatment option for people living with HS.” These data ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0190962223030372

Efficacy and safety of the oral Janus kinase 1 inhibitor ... A total of 60.0% and 65.4% of povorcitinib- and placebo-treated patients had adverse events. Limitations. Baseline lesion counts were mildly imbalanced ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03569371

A Study of the Safety of INCB054707 in Participants ... Safety continues to be evaluated, and short-term adverse events are studied. ... Safety of INCB054707 in Participants With Hidradenitis Suppurativa.

8. incytemi.com incytemi.com/document/Poster/SHSA%202024_Sayed_84-Week%20Safety%20Phase%202%20Povo%20in%20HS%20Study%20(3000368).pdf

Safety of Povorcitinib During 84 Weeks of Treatment * Serious infections included sepsis, worsening of diverticulitis, and perirectal abscess, all of which resolved.