Health TrialsbyHealthPanel

Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy

ConditionKeloid
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

Keloids are common, benign cutaneous overgrowths that manifest clinically as raised, hypertrophic, often hyperpigmented lesions which are formed in response to dermal injury or idiopathic stimuli. Although keloids are a common disease, it's exact incidence and prevalence is not known. Despite the debilitating nature of keloids, current treatment modalities are limited in efficacy; there is no universally effective therapy available to patients. The research team hypothesize that ritlecitinib as a JAK3/TEC inhibitor will be able to reverse both the systemic and local keloid disease process by re-establishing immune homeostasis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female patients ≥ 18 years of age at the time of signing the informed consent document (not more than 10% of the patients can be > 50 years of age).

Patient is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures.

Patient is able to adhere to the study visit schedule and other protocol requirements.

Patients who receive keloidectomy at Day 1/ Baseline only (Group 1): Patient has minimum of one keloid measuring ≥2 cm in length on earlobe or ≥3.0 cm in length on areas) other than earlobe, which has failed prior minimally invasive treatments for keloids including topicals and intralesional corticosteroid injections and that can be surgically resected at Day 1/ Baseline.

Disqualifiers

Patient has a persistent or recurring bacterial infection requiring systemic antibiotics, or clinically significant viral or fungal or helminth parasitic infections, within 2 weeks of the Screening Visit. Any treatment of such infections must have been completed at least 2 weeks prior to the Screening Visit and no new/recurrent infections should have occurred prior to the Baseline Visit.

Patient with current or history of positive human immunodeficiency virus (HIV), or congenital or acquired immunodeficiency (i.e., Common Variable Immunodeficiency [CVID]), or active or untreated latent tuberculosis.

Infected with hepatitis B or C virus.

Patients who have history of single episode of disseminated herpes zoster (HZ) or disseminated herpes simplex or recurrent (> 1 episode of) localized dermatomal HZ

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ritlecitinib

    Drug

    Ritlecitinib 50mg QD for 36 weeks starting at Day 1

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Participants receiving keloidectomyExperimental treatment 1 intervention
Group B: Participants with no keloidectomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recurrence Rate

Recurrence Rate at 9 months (Visit 9) in subjects that received keloidectomy

Time frame
at 9 months (Visit 9)
2

Change in Detroid Keloid Scale Score

Change from Baseline in the Detroit Keloid Scale at 9 months (visit 9) (excluding those without measurable keloids after keloidectomy). Detroit Keloid Scale is a questionnaire consisting of 3 questions that assess the clinical observation (observer keloid assessment) and 4 questions that evaluate the 3 clinical signs of keloids and the impact of keloids on the patient's well-being (patient keloid questionnaire). Keloid Severity (Calculated from Total) 0-4 = mild; 5-9 = moderate; 10-14 = severe Total scores from 0-14, with higher scores indicate greater symptom severity.

Time frame
Baseline and 9 months (Visit 9)

Secondary outcomes

1

Change in Peak keloid tension

Efficacy of ritlecitinib measured by peak keloid tension. Peak keloid tension measures the "hardness" of the skin using an instrument called a tonometer. Full scale ranges 0-100, with higher scores indicating greater "hardness".

Time frame
Visits 2 (Week 0) and up to visit 11 (Week 60)
2

Change in Detroid Keloid Scale Score (DKS)

Efficacy of Ritlecitnib measured using Detroid Keloid Scale. The DKS is a questionnaire consisting of 3 questions that assess the clinical observation (observer keloid assessment) and 4 questions that evaluate the 3 clinical signs of keloids and the impact of keloids on the patient's well-being (patient keloid questionnaire). Keloid Severity (Calculated from Total) 0-4 = mild 5-9 = moderate 10-14 = severe Total scale from 0-14. Higher scores indicate greater symptom severity.

Time frame
Visits 2 (Week 0) and up to visit 11 (Week 60)
3

Change in Pain Numerical Rating Scale (Pain-NRS)

Efficacy of ritlecitinib measured by Pain-NRS. The NRS will range from 0 (no symptoms) to 10 (severe symptoms). Patients indicate the intensity of pain by choosing a number from 0 (no pain) to 10 (worst imaginable pain) that corresponds to the severity of that symptom, with higher scores indicating higher levels of pain.

Time frame
Visits 2 (Week 0) and up to visit 11 (Week 60)
4

Change in Itch-NRS

Efficacy of ritlecitinib measured by Itch-NRS. The NRS will range from 0 (no symptoms) to 10 (severe symptoms). Patients indicate the intensity of itch by choosing a number from 0 to 10 that corresponds to the severity of that symptom. Scale 0-10 0 = No Itch 10 = Worst Itch Imaginable Higher scores indicate greater itch severity.

Time frame
Visits 2 (Week 0) and up to visit 11 (Week 60)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

Pfizer

Collaborator

Source ClinicalTrials.gov
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