Biologic Medications for Skin Inflammation

Recruiting in Palo Alto (17 mi)

Overseen by John E Harris, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: John Harris

Must not be taking: Immunosuppressants

Disqualifiers: Psoriasis, Diabetes, Heart failure, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to answer: how do inflammation and anti-inflammatory skin therapies work in the skin? Inflammation is a protective response from the body's immune system to injury, disease, or irritation. It is a process by which your body's white blood cells and the things they make protect you from infection from outside invaders such as bacteria and viruses.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on systemic broad-spectrum immunosuppression (like prednisone, mycophenolate mofetil, azathioprine, or methotrexate), you cannot participate.

What data supports the effectiveness of the drugs used in the clinical trial for skin inflammation?

Research shows that adalimumab and etanercept, which are part of the trial, have been effective in treating psoriasis and rheumatoid arthritis by reducing disease activity and improving quality of life. Etanercept has shown rapid and significant improvement in psoriatic symptoms, and adalimumab has demonstrated superior efficacy over conventional treatments in psoriasis. ^{1 2 3 4 5}

Is adalimumab safe for human use?

Adalimumab, including its biosimilar versions like CinnoRA®, has been shown to be safe and well-tolerated in healthy volunteers, with no significant differences in safety compared to the original product, Humira®. Common side effects reported for anti-TNF drugs like adalimumab include rash, headache, and infections, but no causal associations with serious adverse reactions have been established. ^{6 7 8 9 10}

How is the drug Adalimumab different from other treatments for skin inflammation?

Adalimumab is a biologic medication that works by targeting and blocking a specific protein called TNF alpha, which plays a key role in causing inflammation. This makes it different from traditional treatments that may not specifically target this protein, offering a more focused approach to reducing inflammation in conditions like psoriasis. ^{2 9 11 12 13}

Research Team

John E Harris, MD PhD

Principal Investigator

University of Massachusetts Chan Medical School

Eligibility Criteria

This trial is for adults over 18 with skin conditions like eczema or a history of certain non-melanoma skin cancers. UMass Medical School students and employees, including non-English speakers with interpreter support, can join. It's not for pregnant women, those on broad immunosuppressants, with specific skin diseases (like psoriasis), high TB risk, liver disease/alcohol abuse, uncontrolled diabetes, compromised immune systems or poor wound healing.

Inclusion Criteria

You have had patch testing done in a previous clinical trial.

I am over 18 and do not have any skin diseases.

I have skin conditions like eczema or a history of certain skin cancers.

Exclusion Criteria

I have diabetes that is not well-controlled.

I have a history of wounds healing poorly.

You have a history of skin that tears easily.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Contact Allergen

Allergic contact dermatitis is induced via squaric acid dibutyl ester (SADBE) and/or known patch test allergens followed by skin and blood sampling.

4 weeks

1 visit (in-person)

Contact Allergen with Immunomodulator Pre-Treatment

Participants are pre-treated with a single dose of a biologic or a single application of a topical steroid, followed by induction of allergic contact dermatitis and skin sampling.

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Adalimumab (Monoclonal Antibodies)
• Betamethasone Valerate (Corticosteroid)
• Canakinumab (Interleukin-1 beta inhibitor)
• Dupilumab (Monoclonal Antibodies)
• Fluticasone Propionate (Corticosteroid)
• Guselkumab (Monoclonal Antibodies)
• Sarilumab (Monoclonal Antibodies)
• Triamcinolone Acetonide (Corticosteroid)
• Ustekinumab (Monoclonal Antibodies)

Trial Overview The study tests how inflammation and anti-inflammatory treatments work in the skin using biologic medications like Dupilumab and Guselkumab among others. Participants will undergo procedures such as skin punch biopsy and suction blistering to study the effects of these therapies on inflammatory responses.

Participant Groups

Group I: Contact Allergen with Immunomodulator Pre-Treatment Experimental Treatment 14 Interventions

Individuals from Arm 1 (Baseline Contact Allergen) who have been exposed to SADBE and/or known patch test allergens followed by skin and blood sampling. These individuals will be pre-treated via administration of a single dose of 1 biologic from the following list: dupilumab, adalimumab, ustekinumab, guselkumab, canakinumab, sarilumab; or a single application of 1 topical steroid from the following list: betamethasone valerate, triamcinolone acetonide, fluticasone propionate. Allergic contact dermatitis will then be induced and the skin sampled.

Group II: Baseline Contact Allergen Experimental Treatment 5 Interventions

Individuals who will have allergic contact dermatitis induced via squaric acid dibutyl ester (SADBE) and/or known patch test allergens followed by skin and blood sampling. There is a protocol to sensitize individuals to SADBE if they have not previously been exposed to SADBE.

Adalimumab is already approved in Canada, Japan for the following indications:

Approved in Canada as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis

Approved in Japan as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Massachusetts Chan Medical School Worcester, MA

Who Is Running the Clinical Trial?

John Harris

Lead Sponsor

Trials

2

Patients Recruited

60+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit-risk analysis of adalimumab versus methotrexate and placebo in the treatment of moderate to severe psoriasis: comparison of adverse event-free response days in the CHAMPION trial. Reich, K., Signorovitch, J., Ramakrishnan, K., et al.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biosimilars: An Update on Clinical Trials (Review of Published and Ongoing Studies). Olteanu, R., Zota, A., Constantin, M.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drugs that block tumour necrosis factor: experience in patients with rheumatoid arthritis. Moreland, LW.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients with psoriasis respond to continuous open-label etanercept treatment after initial incomplete response in a randomized, placebo-controlled trial. Krueger, GG., Elewski, B., Papp, K., et al.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adalimumab, etanercept, and infliximab utilization patterns and drug costs among rheumatoid arthritis patients. Carter, CT., Changolkar, AK., Scott McKenzie, R.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized phase I pharmacokinetic trial comparing the potential biosimilar adalimumab (CinnoRA®) with the reference product (Humira®) in healthy volunteers. Jamshidi, A., Sabzvari, A., Anjidani, N., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritis. Jamshidi, A., Gharibdoost, F., Vojdanian, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, adaptive design, double-blind, 3-arm, parallel study assessing the pharmacokinetics and safety of AVT02, a high-concentration (100 mg/mL) Adalimumab biosimilar, in healthy adult subjects (ALVOPAD FIRST). Wynne, C., Schwabe, C., Lemech, C., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Etanercept]. Sparsa, A.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristic analysis of adverse reactions of five anti-TNFɑ agents: a descriptive analysis from WHO-VigiAccess. Li, M., You, R., Su, Y., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Etanercept. An effective TNF alpha-antagonist in the treatment of psoriatic arthritis and chronic plaque psoriasis]. Wozel, G.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination treatment with monoclonal antibodies: Secukinumab, benralizumab and dupilumab for the combined management of psoriasis and severe asthma. Mahar, PD., Zubrinich, CM., Manuelpillai, N., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Etanercept biosimilar (recombinant human tumor necrosis factor-α receptor II: IgG Fc fusion protein) and methotrexate combination therapy in Chinese patients with moderate-to-severe plaque psoriasis: a multicentre, randomized, double-blind, placebo-controlled trial. Liu, LF., Chen, JS., Gu, J., et al.[2021]

References

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

Benefit-risk analysis of adalimumab versus methotrexate and placebo in the treatment of moderate to severe psoriasis: comparison of adverse event-free response days in the CHAMPION trial. [2015]

2. Croatia pubmed.ncbi.nlm.nih.gov

Biosimilars: An Update on Clinical Trials (Review of Published and Ongoing Studies). [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Drugs that block tumour necrosis factor: experience in patients with rheumatoid arthritis. [2018]

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

Patients with psoriasis respond to continuous open-label etanercept treatment after initial incomplete response in a randomized, placebo-controlled trial. [2015]

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

Adalimumab, etanercept, and infliximab utilization patterns and drug costs among rheumatoid arthritis patients. [2015]

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

A randomized phase I pharmacokinetic trial comparing the potential biosimilar adalimumab (CinnoRA®) with the reference product (Humira®) in healthy volunteers. [2020]

7. England pubmed.ncbi.nlm.nih.gov

A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritis. [2022]

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

A randomized, adaptive design, double-blind, 3-arm, parallel study assessing the pharmacokinetics and safety of AVT02, a high-concentration (100 mg/mL) Adalimumab biosimilar, in healthy adult subjects (ALVOPAD FIRST). [2022]

9. France pubmed.ncbi.nlm.nih.gov

[Etanercept]. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Characteristic analysis of adverse reactions of five anti-TNFɑ agents: a descriptive analysis from WHO-VigiAccess. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

[Etanercept. An effective TNF alpha-antagonist in the treatment of psoriatic arthritis and chronic plaque psoriasis]. [2018]

12. Australia pubmed.ncbi.nlm.nih.gov

Combination treatment with monoclonal antibodies: Secukinumab, benralizumab and dupilumab for the combined management of psoriasis and severe asthma. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

Etanercept biosimilar (recombinant human tumor necrosis factor-α receptor II: IgG Fc fusion protein) and methotrexate combination therapy in Chinese patients with moderate-to-severe plaque psoriasis: a multicentre, randomized, double-blind, placebo-controlled trial. [2021]