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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called anifrolumab to determine its effectiveness in treating Hidradenitis Suppurativa (HS), a painful skin condition with recurring lumps and abscesses. The researchers aim to discover if anifrolumab can reduce symptoms and improve the quality of life for those with HS. Participants will receive the drug intravenously and report on how the treatment affects their daily life. Individuals with HS symptoms for at least six months and inflammation in two different body areas might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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.

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

Studies with anifrolumab have revealed important safety details. This drug, already approved for other conditions, can weaken the immune system, increasing the risk of serious infections. However, many patients have tolerated it well. Researchers continue to gather long-term safety information and monitor for new findings. If considering joining a trial for this drug, discussing it with a doctor is crucial to ensure it's the right choice. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for hidradenitis suppurativa, which typically involve antibiotics and anti-inflammatory drugs, anifrolumab offers a new approach by targeting the type I interferon pathway. This pathway is believed to play a key role in the inflammation and immune response associated with the condition. Researchers are excited about anifrolumab because it directly addresses this pathway, potentially offering more effective relief for patients who don't respond well to existing treatments. With its unique mechanism of action, anifrolumab could change the game for managing hidradenitis suppurativa.

What evidence suggests that anifrolumab might be an effective treatment for Hidradenitis Suppurativa?

Research has shown that anifrolumab effectively treats autoimmune diseases, particularly systemic lupus erythematosus (SLE), by reducing inflammation. People with lupus have experienced improvements in symptoms like skin and joint problems, sometimes within weeks of starting treatment. Anifrolumab blocks certain proteins in the immune system that cause inflammation, which is also significant in Hidradenitis Suppurativa (HS). This trial will evaluate anifrolumab's potential to reduce the painful lumps and sores in HS. While specific research for HS continues, the drug's success in reducing inflammation in lupus offers promise for those considering it for HS. ^{1 2 3 6 7}

Who Is on the Research Team?

Christopher Sayed, MD

Principal Investigator

UNC Dermatology and Skin Cancer Center

Are You a Good Fit for This Trial?

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 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 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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06374212

NCT06374212 | Anifrolumab for Hidradenitis Suppurativa 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 ...

2. saphnelohcp.com saphnelohcp.com/clinical-data.html

Clinical Data - SAPHNELO For HCPs The reduction in disease activity seen in BICLA and SRI-4 was related primarily to improvement in the mucocutaneous and musculoskeletal organ systems.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11660324/

Anifrolumab Study for Treatment Effectiveness in the Real ... This study uses a multinational approach, incorporating both patient-reported and clinical-reported outcomes to assess medication usage.

4. saphnelo.com saphnelo.com/about-saphnelo

What is SAPHNELO® (anifrolumab-fnia)? | About ... Patients experienced improvements in their lupus symptoms; some within weeks after starting treatment.¶. RESULTS MAY VARY. TALK TO YOUR ...

5. clinicaltrials.eu clinicaltrials.eu/inn/anifrolumab/

Anifrolumab – Application in Therapy and Current Clinical ... Anifrolumab is a promising drug being studied in clinical trials for various autoimmune conditions, particularly systemic lupus erythematosus (SLE) and lupus ...

6. sigma.larvol.com sigma.larvol.com/ott.php?e1=4740&e2=&sourcepg=TZ&itype=0,1

Online Trial Tracker LAVENDER, NCT06015737: A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus ...

7. saphnelo.com saphnelo.com/safety

Safety | SAPHNELO® (anifrolumab-fnia) Injection for ... SAPHNELO may cause serious side effects, including: Serious infections: SAPHNELO can lower the ability of your immune system to fight infections.