Ritlecitinib for Hidradenitis Suppurativa

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pfizer

Disqualifiers: Immunodeficiency, Systemic infection, Viral infection, others

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

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effects of a new treatment, Ritlecitinib, for hidradenitis suppurativa (HS), a condition that causes painful, long-lasting red skin lumps. Participants will receive either Ritlecitinib or a placebo to determine if the treatment effectively manages HS symptoms. The trial seeks participants with moderate to severe HS who have previously tried antibiotics without success. Participants will engage in the study for about six months, attending several clinic visits and regularly reporting their health and symptoms. The study will help determine if Ritlecitinib is a safe and effective option for treating HS. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Ritlecitinib is likely to be safe for humans?

Research has shown that ritlecitinib has been tested in several studies to assess its safety. In one study, no serious side effects were linked to the treatment, although 58 mild side effects were reported. This indicates that while some side effects occurred, they were not severe.

Another study found that serious side effects occurred in about 5% of patients, including two deaths not directly related to ritlecitinib. This treatment is being studied for its effects on hidradenitis suppurativa, a skin condition that causes painful lumps.

Overall, these studies suggest that ritlecitinib is generally well-tolerated, though some mild to moderate side effects might occur. ^{1 2 3 4 5}

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

Ritlecitinib is unique because it targets a specific pathway known as the Janus kinase (JAK) pathway, which plays a role in the inflammation process seen in conditions like Hidradenitis Suppurativa. Most treatments for this condition, like antibiotics or biologics, generally aim to reduce inflammation without targeting this particular pathway. By honing in on the JAK pathway, Ritlecitinib has the potential to offer a more targeted approach, which could lead to improved effectiveness and fewer side effects. Researchers are excited about this treatment because it represents a novel way to address the underlying causes of the disease, rather than just managing symptoms.

What evidence suggests that Ritlecitinib might be an effective treatment for hidradenitis suppurativa?

Research has shown that ritlecitinib, an oral medication, may help treat conditions like alopecia areata, which causes hair loss. In one study, participants taking ritlecitinib experienced significant improvements lasting for 48 weeks. The medication targets certain proteins in the immune system, potentially reducing inflammation in conditions like hidradenitis suppurativa. Although direct data for hidradenitis suppurativa is limited, positive results in similar conditions suggest it could be effective. This trial will assess the effectiveness of ritlecitinib in reducing the painful skin lumps associated with hidradenitis suppurativa. Participants will receive either ritlecitinib or a placebo. ^{4 6 7 8 9}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Adults with moderate or severe Hidradenitis Suppurativa (HS), who didn't respond to or couldn't tolerate antibiotics, can join this study. They'll take a pill daily for about 6 months and attend roughly 10 clinic visits for health assessments.

Inclusion Criteria

I am between 18 and 75 years old.

I have had moderate to severe HS for over 6 months and antibiotics haven't worked.

Exclusion Criteria

Known immunodeficiency disorder

I have 20 or more draining fistulas.

I have an active skin condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a loading dose of ritlecitinib or placebo for 8 weeks, followed by a maintenance dose for another 8 weeks

16 weeks

Visits on Day 1, and then every 1, 2, or 4 weeks until week 16

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ritlecitinib

Trial Overview The trial is testing Ritlecitinib's safety and effectiveness against HS compared to a placebo. Participants will be randomly assigned to either the medication or placebo group and follow a dosing schedule starting with a higher dose that transitions to maintenance levels.

How Is the Trial Designed?

Group I: Study Intervention Experimental Treatment 1 Intervention

Participants will receive one oral dose once daily (QD), starting with a loading dose of ritlecitinib for 8 weeks, followed by maintenance for 8 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive matching placebo.

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07228390?lastUpdPost=2020-01-16_

NCT07228390 | A 16-Week Study to Learn About the ... Difference in proportion of responders based on Hidradenitis Suppurativa Clinical Response achieving at least 50% reduction from baseline ( ...

2. ovid.com ovid.com/journals/jaade/pdf/10.1016/j.jaad.2022.06.453~ritlecitinib-pf-06651600-an-oral-jak3tec-inhibitor-shows

33304 Ritlecitinib (PF-06651600), an oral JAK3/TEC ... Results: HS risk was not significantly different in TGD patients on masculinizing GAHT versus ciswomen (aRR ¼ 1.10 (95% CI 0.69-1.75), P ¼ . 701) nor in TGD ...

3. academic.oup.com academic.oup.com/ced/article/50/9/1866/8125823

Ritlecitinib in clinical practice: a real-world study of efficacy ... In our 12-week study, ritlecitinib at 50 mg daily showed promising efficacy and acceptable safety in Chinese patients with moderate to severe AA. Notably, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11352834/

Biologics and Small Molecule Targeted Therapies for ... The efficacy and safety of the drug were consistent amongst patient cohorts aged 12 to 17 years and 18 years of age and older [5]. The ...

5. jaad.org jaad.org/article/S0190-9622(22)01297-X/fulltext

33183 Efficacy of the oral JAK3/TEC inhibitor ritlecitinib (PF ... Conclusion: Ritlecitinib demonstrated sustained efficacy over 48 weeks in patients with AA with ≥50% scalp hair loss. Article metrics. Related Articles.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07228390?aggFilters=status%3A%2Cphase%3A

NCT07228390 | A 16-Week Study to Learn About the ... The purpose of this study is to learn about the safety and effects of the study medicine (called Ritlecitinib) for the possible treatment of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10307738/

The Current Clinical Trial Landscape for Hidradenitis ... The primary endpoint was safety, and while no serious adverse events were reported, 58 non-serious adverse events were reported [26]. One of the ...

8. scholarlycommons.henryford.com scholarlycommons.henryford.com/dermatology_articles/722/

"Efficacy and safety of oral ritlecitinib for the treatment ... RESULTS: A total of 364 patients were treated in the dose-ranging period. Significant differences from placebo in percent change from baseline ...

9. jaad.org jaad.org/article/S0190-9622(24)01427-0/fulltext

52238 Updated integrated safety analysis of ritlecitinib over ... Serious AEs were similar in both groups (any-ritlecitinib: 5.0% [2.5/100 PY]; 50-mg: 5.0% [2.7/100 PY]), including 2 deaths (breast cancer and acute respiratory ...