Anifrolumab for Hidradenitis Suppurativa

Overseen By Erika Hanami

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of North Carolina, Chapel Hill

Must be taking: Topical antibiotics, Oral antibiotics

Must not be taking: Immunomodulatory, Biologic treatments

Disqualifiers: Cancer, Severe COVID-19, Active Hepatitis, 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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 24 weeks

15 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking oral and intravenous antibiotics unless you are on a stable course of certain oral antibiotics for at least 28 days before starting the trial. You cannot take other immunomodulatory or biologic treatments for Hidradenitis Suppurativa during the study.

How does the drug Anifrolumab differ from other treatments for Hidradenitis Suppurativa?

Anifrolumab is unique because it targets the interferon-alpha receptor, which is different from other treatments for Hidradenitis Suppurativa that may not focus on this specific pathway. This mechanism is similar to its use in other conditions, where it modulates immune responses by interfering with the action of interferon-alpha, a protein involved in inflammation. ^{1 2 3 4 5}

What is the purpose of this trial?

This clinical trial aims to study if a drug called anifrolumab works to treat Hidradenitis Suppurativa (HS) as well as its effect in quality of life before and after treatment. Anifrolumab is a monoclonal antibody that inhibits several processes that have been shown to be involved in the development of HS. The study lasts approximately 40 weeks separated into a screening, treatment, and follow-up phase. Researchers determine if it is safe for the you to receive the drug and if you are eligible for the study during Screening. If eligible for the study, the treatment phase lasts 24 weeks (or six months) with one follow-up visit 12 weeks after the last visit in the treatment phase. During the treatment phase, participants will be asked to come to clinic every two weeks for the first month of treatment, and monthly thereafter for a total of eight treatment visits. Participants will be asked to: * Complete questionnaires asking about the effect of HS in their daily lives and their perception of HS and treatment received. * Receive related medical evaluation * Receive the study drug intravenously * Stay 20 minutes after the infusion for monitoring

Research Team

Christopher Sayed, MD

Principal Investigator

UNC Dermatology and Skin Cancer Center

Eligibility Criteria

This trial is for individuals with Hidradenitis Suppurativa (HS), a chronic skin condition. Participants must pass a screening to confirm they're safe to receive anifrolumab and meet study requirements. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I have 5 or more inflamed skin spots.

I have had symptoms of hidradenitis suppurativa for 6 months or more.

I have never had, nor do I currently have Tuberculosis.

Exclusion Criteria

I am currently on medication for Hidradenitis Suppurativa.

Are pregnant, lactating, or intend to become pregnant or lactate for up to 16 weeks following the last dose of study drug upon signing the Informed Consent Form (ICF)

Clinical Cytomegalovirus or Epstein-Barr infection that has not completely resolved within 12 weeks prior to signing the informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive anifrolumab intravenously with visits every two weeks for the first month and monthly thereafter

24 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person)

Treatment Details

Interventions

• Anifrolumab

Trial Overview The trial tests anifrolumab, a monoclonal antibody designed to block processes involved in HS development. It involves approximately 40 weeks of participation, including screening, treatment every two weeks then monthly for six months, and follow-up.

Participant Groups

Group I: Anifrolumab Experimental Treatment 1 Intervention

Participants will receive anifrolumab (loading dose of 900mg) intravenously at the first visit, week 4 and week 8. Anifrolumab (maintenance dose of 600mg) will be administered intravenously for weeks 12, 16, and 20.

Anifrolumab is already approved in United States, European Union for the following indications:

Approved in United States as Saphnelo for:

• Moderate to severe systemic lupus erythematosus (SLE)

Approved in European Union as Saphnelo for:

• Moderate to severe systemic lupus erythematosus (SLE)

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Findings from Research

Recombinant interferon-alpha (rIFNalpha) has shown effectiveness in prolonging disease-free survival (DFS) in malignant melanoma when used at high dosages (≥10MU), but it does not improve overall survival (OS).

In metastatic renal cell carcinoma (RCC), current evidence does not support the use of adjuvant rIFNalpha, and while response rates are around 15% for metastatic melanoma and RCC, these responses do not translate into improved survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential of interferon-alpha in solid tumours: part 1. Decatris, M., Santhanam, S., O'Byrne, K.[2018]

In a study involving 407 patients with stage IIA and IIB melanoma, the combination of interferon alfa (IFNalpha) and isotretinoin did not improve disease-free or overall survival rates compared to IFNalpha alone, leading to the trial being stopped for futility.

The 5-year disease-free survival rates were 55% for the isotretinoin group and 67% for the placebo group, while overall survival rates were 76% for the isotretinoin group and 81% for the placebo group, indicating that isotretinoin does not provide additional benefits in this treatment context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective, randomized, multicenter, double-blind placebo-controlled trial comparing adjuvant interferon alfa and isotretinoin with interferon alfa alone in stage IIA and IIB melanoma: European Cooperative Adjuvant Melanoma Treatment Study Group. Richtig, E., Soyer, HP., Posch, M., et al.[2013]

In a study involving normal donors and patients with Condylomata acuminata, the use of human leukocyte-derived interferon alfa-n3 (Alferon N Injection) did not lead to an increase in human anti-murine antibodies (HAMA), indicating its safety regarding immune response.

Both treatment and placebo groups showed similar levels of HAMA, suggesting that the interferon alfa-n3 does not provoke an immune reaction against murine components, which is important for its therapeutic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trace amounts of murine immunoglobulin in affinity purified leukocyte interferon alpha are not immunogenic. Axelrod, HR., Liao, MJ., Kuchler, M., et al.[2011]

Amarillo Biosciences is developing low-dose oral interferon-alpha (IFNalpha) as a potential treatment for several conditions, including primary Sjøgren's syndrome and oral mucositis in cancer patients, indicating its broad therapeutic potential.

The product is already registered in Ghana for treating hepatitis B virus (HBV) infection, showcasing its initial approval and use in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interferon-alpha. Amarillo Biosciences. Barnard, DL.[2007]

In a study involving 154 patients with condylomata acuminata, podophyllin resin was significantly more effective than interferon alfa 2a, achieving complete clearance in 45% of patients compared to only 23% for interferon at three months.

At nine months, the recurrence rates were lower for podophyllin, with 22 out of 30 patients remaining clear of lesions, compared to 10 out of 13 in the interferon group, indicating that podophyllin may offer better long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of interferon alfa-2a and podophyllin in the treatment of primary condylomata acuminata. The Condylomata International Collaborative Study Group. [2019]

References

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

Potential of interferon-alpha in solid tumours: part 1. [2018]

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

Prospective, randomized, multicenter, double-blind placebo-controlled trial comparing adjuvant interferon alfa and isotretinoin with interferon alfa alone in stage IIA and IIB melanoma: European Cooperative Adjuvant Melanoma Treatment Study Group. [2013]

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

Trace amounts of murine immunoglobulin in affinity purified leukocyte interferon alpha are not immunogenic. [2011]

4. England pubmed.ncbi.nlm.nih.gov

Interferon-alpha. Amarillo Biosciences. [2007]

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

A comparison of interferon alfa-2a and podophyllin in the treatment of primary condylomata acuminata. The Condylomata International Collaborative Study Group. [2019]