Upadacitinib for Prurigo Nodularis

Overseen By Ashley Reed

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Psoriasis Treatment Center of Central New Jersey

Must not be taking: Antibiotics, Antivirals, Antiprotozoals, Antifungals

Disqualifiers: Active infections, Active malignancy, Severe renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

A single center, open-label study of 25 subjects to assess 24 weeks upadacitinib in patients with moderate-to-severe prurigo nodularis.

Do I need to stop my current medications to join 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 study team or your doctor.

What data supports the effectiveness of the drug Upadacitinib for treating prurigo nodularis?

Upadacitinib has shown effectiveness in rapidly reducing itch and improving skin condition in patients with moderate-to-severe atopic dermatitis, a condition characterized by intense itching, which suggests it may also help with prurigo nodularis, another itchy skin condition. ^{1 2 3 4 5}

How does the drug Upadacitinib differ from other treatments for prurigo nodularis?

Upadacitinib is unique because it is a Janus kinase (JAK) inhibitor, which works by blocking specific pathways involved in inflammation, potentially offering a new approach for treating prurigo nodularis compared to existing treatments that focus on different mechanisms. ^{6 7 8 9 10}

Eligibility Criteria

Adults aged 18-64 with moderate-to-severe prurigo nodularis, having at least 10 lesions and not responding to certain creams. Women must not be pregnant or breastfeeding and use birth control. Excludes those with severe kidney issues, recent cancers (except some skin cancers), active infections including TB, other skin conditions, or uncontrolled illnesses.

Inclusion Criteria

I am not pregnant, not breastfeeding, and using birth control if able to have children.

I have moderate-to-severe itchy bumps on my legs, arms, or trunk.

I've tried strong skin creams for 2 weeks without success or can't use them for health reasons.

Exclusion Criteria

I have severe kidney problems or am on dialysis.

I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that's been fully treated.

I do not have active TB, or if I had TB, it was fully treated.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 15mg upadacitinib for 24 weeks, with an option to increase to 30mg at week 8 if necessary

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Upadacitinib

Trial Overview The trial is testing Upadacitinib for patients with prurigo nodularis over a period of 24 weeks. It's an open-label study at a single center involving 25 subjects who have had inadequate responses to topical treatments.

Participant Groups

Group I: Upadacitinib Experimental Treatment 1 Intervention

Open-label use of 15mg upadacitinib. Subjects have the option to increase to 30mg at week 8 if the investigator deems it necessary.

Who Is Running the Clinical Trial?

Psoriasis Treatment Center of Central New Jersey

Lead Sponsor

Trials

18

Recruited

530+

AbbVie

Industry Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

In a post hoc analysis of three phase 3 trials involving 2583 patients, acne was identified as a common side effect of upadacitinib treatment for atopic dermatitis, affecting 9.8% of patients on 15 mg, 15.2% on 30 mg, and 2.2% on placebo.

Most cases of acne were mild to moderate and did not significantly affect patient quality of life, with many cases requiring no treatment or being managed effectively with topical therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. Mendes-Bastos, P., Ladizinski, B., Guttman-Yassky, E., et al.[2022]

Upadacitinib, a selective JAK inhibitor, was well tolerated in a study involving 2485 patients (including 333 adolescents) with moderate-to-severe atopic dermatitis, treated for an average of about one year.

The safety profile showed no new significant risks, with common adverse events being mild, such as acne, and serious adverse events occurring at rates similar to those expected in the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of upadacitinib in moderate-to-severe atopic dermatitis: An integrated analysis of phase 3 studies. Guttman-Yassky, E., Thyssen, JP., Silverberg, JI., et al.[2023]

Upadacitinib, at doses of 15 mg and 30 mg, demonstrated long-term efficacy in treating moderate-to-severe atopic dermatitis over 112 weeks, with sustained improvements in skin severity and itch relief.

The treatment was generally well tolerated, with a safety profile similar to short-term studies, and serious adverse events were infrequent, indicating that upadacitinib is a safe option for patients with atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Upadacitinib for Atopic Dermatitis in Japan: 2-Year Interim Results from the Phase 3 Rising Up Study. Katoh, N., Ohya, Y., Murota, H., et al.[2023]

In a study of 21 patients with moderate-to-severe atopic dermatitis, upadacitinib demonstrated a rapid and significant reduction in disease severity, with Eczema Area and Severity Index (EASI) scores dropping from a mean of 19.8 at baseline to 0.6 by Week 52.

All patients experienced effective itch control within just 4 weeks of treatment, and no severe infections or major cardiovascular events were reported, indicating a favorable safety profile for upadacitinib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upadacitinib effectiveness in moderate-to-severe atopic dermatitis: A real-life multicentre and retrospective study. Melgosa Ramos, FJ., González-Delgado, V., Motilla, JMS., et al.[2023]

In a study of 105 patients with moderate-to-severe atopic dermatitis treated with upadacitinib, achieving a low itch score (PP-NRS ≤ 1) by week 2 was strongly associated with a higher rate of complete skin clearance (EASI 100) by week 24 (42.9% vs. 1.4%).

The study suggests that early relief of itch can be a predictive marker for later skin clearance in patients receiving upadacitinib, highlighting the importance of managing itch early in treatment for better long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early itch relief with upadacitinib predicts later skin clearance in Atopic dermatitis. Hagino, T., Yoshida, M., Hamada, R., et al.[2023]

Prurigo nodularis (PN) is a chronic condition with no FDA-approved treatments, characterized by severe itching and skin nodules, and current therapies often have significant side effects.

Dupilumab, a monoclonal antibody that targets interleukin-4 and interleukin-13 pathways, shows promise as a safe and effective treatment for PN, based on emerging positive data in the literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab as promising treatment for prurigo nodularis: current evidences. Toffoli, L., Farinazzo, E., Zelin, E., et al.[2022]

Dupilumab, a monoclonal antibody that blocks IL-4 and IL-13 signaling, has been approved as the first effective treatment for prurigo nodularis (PN), a chronic inflammatory skin condition characterized by itchy nodules.

Clinical trials demonstrated that dupilumab significantly reduces both itching and the number of skin lesions in patients with PN, marking a potential shift in treatment strategies for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab for the Treatment of Prurigo Nodularis. Alkhaleefa, A., Woo, TE., Parsons, L.[2023]

Dupilumab is an effective treatment for prurigo nodularis (PN), with 82.22% of patients experiencing at least a 50% reduction in itch severity after treatment, and 48.88% achieving complete resolution after an average of 19.28 weeks.

Patients with atopic dermatitis-related PN experienced a delayed response to dupilumab, requiring longer treatment times for relief compared to those without atopic dermatitis, highlighting the need for tailored treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab in prurigo nodularis: a systematic review of current evidence and analysis of predictive factors to response. Husein-ElAhmed, H., Steinhoff, M.[2022]

Topical treatments for prurigo nodularis, including corticosteroids and calcineurin inhibitors, have shown beneficial effects in clinical studies, with a level of evidence of 2b or higher across all five studies reviewed.

Phototherapy and systemic treatments like thalidomide, pregabalin, and amitriptyline also demonstrated effectiveness, but more high-quality studies and randomized controlled trials are needed to confirm their safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of evidence-based treatments for prurigo nodularis. Qureshi, AA., Abate, LE., Yosipovitch, G., et al.[2019]

In a phase 3 trial involving 274 adults with moderate-to-severe prurigo nodularis, nemolizumab significantly reduced itch and improved skin condition compared to placebo, with 56.3% of patients experiencing a notable reduction in itch versus 20.9% in the placebo group.

Nemolizumab also led to significant improvements in sleep quality and overall skin assessment, with common side effects being mild, such as headaches and atopic dermatitis, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. Kwatra, SG., Yosipovitch, G., Legat, FJ., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Safety of upadacitinib in moderate-to-severe atopic dermatitis: An integrated analysis of phase 3 studies. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Upadacitinib for Atopic Dermatitis in Japan: 2-Year Interim Results from the Phase 3 Rising Up Study. [2023]

4. Australia pubmed.ncbi.nlm.nih.gov

Upadacitinib effectiveness in moderate-to-severe atopic dermatitis: A real-life multicentre and retrospective study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Early itch relief with upadacitinib predicts later skin clearance in Atopic dermatitis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Dupilumab as promising treatment for prurigo nodularis: current evidences. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Dupilumab for the Treatment of Prurigo Nodularis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Dupilumab in prurigo nodularis: a systematic review of current evidence and analysis of predictive factors to response. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A systematic review of evidence-based treatments for prurigo nodularis. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. [2023]