How to Find HS Clinical Trials: Get Involved

How to Find HS Clinical Trials: Your Definitive Guide to Getting Involved

Living with Hidradenitis Suppurativa (HS) can be a challenging journey, marked by chronic inflammation, painful lesions, and the often frustrating search for effective treatments. While existing therapies offer relief for many, they don’t work for everyone, and the quest for better solutions is ongoing. This is where clinical trials become not just an option, but a vital pathway for both personal health improvement and contributing to broader medical advancements. Participating in an HS clinical trial offers access to cutting-edge therapies, specialized medical care, and the opportunity to make a tangible difference in the lives of countless others.

This guide will equip you with the practical knowledge and actionable steps needed to confidently navigate the world of HS clinical trials. We’ll cut through the jargon and provide a clear roadmap, ensuring you understand how to find trials, assess your eligibility, and prepare for participation.

Understanding HS Clinical Trials: The Basics

Before diving into the search, it’s crucial to grasp what clinical trials are and their fundamental purpose. Clinical trials are research studies conducted with human volunteers to evaluate new medical interventions, such as drugs, devices, or procedures. For HS, these trials aim to:

• Test New Treatments: Evaluate the safety and efficacy of novel medications or therapeutic approaches specifically designed to target HS.

• Improve Existing Treatments: Explore new ways to use current treatments or combine them for better outcomes.

• Understand the Disease: Gather more in-depth data on HS progression, risk factors, and biological mechanisms to inform future research.

Clinical trials are organized into phases, each with a distinct objective:

• Phase I: Focuses on safety and dosage, often involving a small number of healthy volunteers or patients.

• Phase II: Assesses effectiveness and further evaluates safety in a larger group of patients with HS.

• Phase III: Compares the new treatment to standard treatments, typically involving hundreds or thousands of participants, to confirm efficacy and monitor side effects.

• Phase IV: Occurs after a drug is approved, monitoring its long-term effects and gathering additional information on its use.

Understanding these phases can help you determine the stage of development for a particular treatment and the level of data already available.

Step 1: Initiating Your Search for HS Clinical Trials

Finding relevant HS clinical trials requires a strategic approach. Don’t rely on a single source; cast a wide net to maximize your chances.

Leveraging Online Databases

The most comprehensive and reliable resources for finding clinical trials are online databases. These platforms are regularly updated and provide detailed information about ongoing studies.

• ClinicalTrials.gov: This is the primary database of clinical studies conducted around the world, maintained by the U.S. National Library of Medicine (NLM).
  • Actionable Tip: Go to ClinicalTrials.gov. In the “Condition or disease” field, type “Hidradenitis Suppurativa” or “HS.” You can further refine your search by adding keywords like “moderate to severe,” “new treatment,” or specific locations (e.g., “Los Angeles” or “United Kingdom”).

  • Example: A search for “Hidradenitis Suppurativa” might yield results like “NCT06959225: Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1).” Click on the trial to see details like location, eligibility criteria, study status (e.g., “Recruiting,” “Not yet recruiting,” “Active, not recruiting”), and contact information for the research site.

• EU Clinical Trials Register (clinicaltrialsregister.eu): For those in Europe, this register provides information on clinical trials conducted within the European Union.

  • Actionable Tip: Navigate to clinicaltrialsregister.eu. Use the “Search” function and enter “Hidradenitis Suppurativa.” Explore advanced search options to filter by country, age group, gender, or trial phase.

  • Example: You might find “EudraCT Number: 2015-002321-20: A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED CLINICAL TRIAL OF THE SAFETY AND EFFICACY OF MABp1, A HUMAN ANTIBODY TARGETING INTERLEUKIN-1ALPHA, IN PATIENTS WITH HIDRADENITIS SUPPURATIVA.” This gives you a clear indication of the drug being tested and the trial design.

• World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP): This portal provides access to a wide range of clinical trial registers globally. While it aggregates information, ClinicalTrials.gov and the EU register are often more direct for HS-specific searches.

Connecting with HS Advocacy and Support Organizations

Many patient advocacy groups and foundations dedicated to HS maintain lists of ongoing clinical trials or can direct you to relevant resources. These organizations often have strong connections with researchers and can provide valuable insights.

• Actionable Tip: Visit the websites of organizations like the Hidradenitis Suppurativa Foundation or local HS support groups. Look for sections specifically titled “Clinical Trials,” “Research,” or “Get Involved.”

• Example: The Hidradenitis Suppurativa Foundation’s website might feature a “Clinical Trials” page linking directly to specific studies or providing a curated list of research centers actively recruiting HS patients. They might also have contact forms to connect you with research opportunities.

Consulting with Your Healthcare Provider

Your dermatologist or the healthcare professional managing your HS is a crucial resource. They often have knowledge of ongoing trials, particularly those at their institution or within their professional network.

• Actionable Tip: During your next appointment, express your interest in clinical trials. Ask them:
  • “Are there any HS clinical trials currently recruiting that you believe I might be eligible for?”

  • “Do you know of any research centers or academic institutions in the area that specialize in HS and conduct trials?”

  • “Can you help me understand how my current treatment plan might affect my eligibility for trials?”

• Example: Your dermatologist might say, “Yes, we’re actually a site for a new Phase II study on an IL-17 inhibitor for moderate to severe HS. Based on your current condition and treatment history, you might be a good candidate. Let me connect you with our research coordinator.”

Exploring University and Medical Center Websites

Major universities and medical centers with dermatology departments often conduct their own clinical research. Their websites frequently have dedicated sections for clinical trials.

• Actionable Tip: Search for “Hidradenitis Suppurativa clinical trials [Your City/Region]” or “Dermatology research studies [University Name].” Look for “clinical research,” “investigational studies,” or “participate in research” links on their departmental pages.

• Example: Searching for “UCSF Hidradenitis Suppurativa Clinical Trials” would lead you to a page listing their ongoing studies, such as “Clinical and Biological Characteristics of Hidradenitis Suppurativa” or trials testing specific drugs.

Step 2: Assessing Eligibility – Decoding Inclusion and Exclusion Criteria

Once you’ve identified potential trials, the next critical step is to understand the eligibility criteria. Every clinical trial has strict inclusion and exclusion criteria, which are specific requirements that potential participants must meet (inclusion) or not meet (exclusion). These criteria are vital for ensuring the safety of participants and the integrity of the study results.

Common Inclusion Criteria for HS Trials

• Diagnosis of HS: You must have a confirmed diagnosis of Hidradenitis Suppurativa.
  • Concrete Example: “Clinical diagnosis of moderate to severe HS for at least 6 months.” This means your HS must be established and fall within a certain severity range.
• Age Requirements: Most trials have specific age ranges, often 18 years and older, though some may include adolescents.
  • Concrete Example: “Participants must be 18 to 75 years of age, inclusive.”
• Disease Severity: Many trials target specific HS severity levels, often moderate to severe, as assessed by a clinical scale (e.g., Hurley Staging, Hidradenitis Suppurativa Physician Global Assessment [HS-PGA]).
  • Concrete Example: “HS-PGA score of 3 (moderate) or 4 (severe) at screening.” This indicates that your HS must be active and of a certain intensity.
• Presence of Lesions: The trial may require you to have active lesions in specific anatomical areas.
  • Concrete Example: “Presence of HS lesions in at least two distinct anatomic areas (e.g., axilla, groin, gluteal).”
• Previous Treatment History: Some trials require participants to have failed previous treatments or to be treatment-naïve.
  • Concrete Example: “Intolerance or inadequate response to at least one systemic antibiotic therapy for HS.” Or conversely, “No prior treatment with biologic therapies for HS.”

Common Exclusion Criteria for HS Trials

• Comorbid Conditions: Certain co-existing medical conditions might exclude you due to potential interactions with the study drug or increased risk.
  • Concrete Example: “History of uncontrolled diabetes, active hepatitis B or C, or HIV infection.”
• Medication Use: Current use of certain medications might interfere with the study drug or confound results.
  • Concrete Example: “Concurrent use of systemic corticosteroids within 4 weeks prior to screening.”
• Pregnancy or Breastfeeding: For safety reasons, pregnant or breastfeeding individuals are typically excluded.
  • Concrete Example: “Pregnant or breastfeeding women, or women of childbearing potential not using highly effective contraception.”
• Other Skin Conditions: Other dermatological conditions that might interfere with HS assessment could lead to exclusion.
  • Concrete Example: “Active psoriasis or eczema requiring systemic treatment.”
• Participation in Other Trials: Being enrolled in another clinical trial at the same time is usually not permitted.
  • Concrete Example: “Participation in another interventional clinical study within 30 days prior to screening.”

Practical Steps to Self-Assess Eligibility

1. Read Carefully: When viewing a trial on ClinicalTrials.gov or a research center’s website, thoroughly read the “Eligibility” section.

2. Highlight Key Points: Note down all inclusion and exclusion criteria that seem relevant to your situation.

3. Self-Evaluate: Go through each point and honestly assess if you meet it. Be realistic. If a criterion states “no history of inflammatory bowel disease,” and you have Crohn’s disease, you are likely excluded.

4. Prepare Questions: For any criteria you’re unsure about, write down specific questions for the research coordinator. For instance, if it says “stable medical condition,” you might ask, “What is considered a ‘stable’ condition for my hypertension?”

5. Don’t Disqualify Yourself Prematurely: If you’re borderline on a criterion, it’s always best to contact the study site. They may have more flexibility or a clearer interpretation.

Step 3: Making Contact and Initial Screening

Once you’ve identified a promising trial and have a preliminary sense of your eligibility, the next step is to initiate contact with the research site.

Contacting the Research Coordinator

Every clinical trial listing will provide contact information, usually for a “Contact” or “Recruiting” person, often a clinical research coordinator (CRC).

• Actionable Tip: Locate the phone number or email address listed on the trial record. Prepare a brief introduction stating your interest in the trial (referencing its NCT number if applicable) and why you believe you might be eligible.

• Example: “Hello, my name is [Your Name], and I’m calling about the Hidradenitis Suppurativa study, NCT[Trial Number], that I saw on ClinicalTrials.gov. I’m interested in learning more about participation as I meet some of the initial criteria.”

The Pre-Screening Process

The first conversation with the research coordinator will typically involve a pre-screening. This is a quick assessment to determine if you meet the most basic eligibility requirements before an in-person visit.

• What to Expect: The coordinator will ask questions about your HS diagnosis, severity, current medications, other medical conditions, and general health. Be honest and accurate in your responses.

• Concrete Example of Questions:

  • “How long have you been diagnosed with HS?”

  • “What areas of your body are currently affected by HS?”

  • “What treatments have you tried for your HS, and for how long?”

  • “Do you have any other significant medical conditions, such as heart disease or diabetes?”

  • “Are you currently taking any prescription medications?”

• Actionable Tip: Have your medical history, including approximate dates of diagnosis and previous treatments, readily available. It’s helpful to have a list of all current medications, including dosages.

Step 4: The Informed Consent Process

If you pass the pre-screening, the next crucial step is the informed consent process. This is a cornerstone of ethical clinical research and ensures you are fully aware of all aspects of the study before agreeing to participate.

What is Informed Consent?

Informed consent is a continuous dialogue between you and the research team, culminating in a signed document. It’s not just a signature; it’s an educational process. You will be provided with a detailed “Informed Consent Form” (ICF).

• Actionable Tip: Treat the ICF as a contract. Read every word carefully. Don’t skim. This document outlines:
  • Purpose of the study: Why is this research being done?

  • Procedures involved: What tests, visits, and treatments will you undergo?

  • Potential risks and benefits: What are the possible side effects, discomforts, or benefits of participating? This includes risks associated with the study drug and procedures.

  • Alternatives: What other treatment options are available to you outside of the trial?

  • Confidentiality: How will your personal information be protected?

  • Voluntary participation: You can withdraw from the study at any time without penalty or affecting your standard medical care.

  • Compensation: Will you be compensated for your time, travel, or other expenses?

• Example: The ICF might state, “Participants will receive the investigational drug X or a placebo. Potential risks include nausea, fatigue, and injection site reactions. The study involves weekly injections for 12 weeks, followed by monthly follow-up visits for 6 months, and requires 8 blood draws and 4 physical examinations over the study period.”

Asking Crucial Questions

This is your opportunity to clarify any doubts. No question is too small or insignificant.

• Actionable Tip: Prepare a list of questions before your informed consent meeting. Some essential questions to ask:
  • “What is the specific purpose of this trial, and what is the new treatment designed to do for HS?”

  • “What are the most common and serious potential side effects of the investigational drug?”

  • “Will I receive the actual study drug, or is there a chance I’ll get a placebo? If so, for how long?” (If it’s a double-blind, placebo-controlled trial, neither you nor the study team will know who receives the active drug until the trial concludes).

  • “How often will I need to visit the clinic, and what will each visit entail (e.g., blood tests, physical exams, questionnaires)?”

  • “What are the potential financial costs to me, if any? Will travel or parking be reimbursed?”

  • “Who will be my primary contact for questions or concerns during the trial?”

  • “What happens if my HS worsens during the trial? Will I be able to receive standard care?”

  • “What happens after the trial ends? Will I have continued access to the study drug if it proves effective?”

  • “How will my privacy be protected?”

  • “What is the total duration of the study, from start to finish?”

  • “Will I be informed of the study results once they are available?”

• Concrete Example: If the coordinator explains the placebo arm, you might ask, “If I’m in the placebo group and my HS flares significantly, what is the protocol for intervention or switching to active treatment?”

Taking Your Time

Do not feel pressured to sign the ICF immediately. You have the right to take the document home, discuss it with family or your primary doctor, and consider your decision.

• Actionable Tip: Request a copy of the ICF to review at your leisure. If you have a trusted friend or family member, ask them to read it with you to catch anything you might have missed.

Step 5: The Screening Visit

After you’ve provided informed consent, you’ll typically undergo a comprehensive screening visit to confirm your eligibility. This involves a series of tests and evaluations.

What to Expect During Screening

The screening visit is designed to verify that you meet all inclusion and exclusion criteria and that it’s safe for you to participate.

• Medical History Review: A thorough review of your entire medical history, not just your HS.

• Physical Examination: A comprehensive physical exam, including a detailed assessment of your HS lesions and severity by the study physician.

• Laboratory Tests: Blood work (including blood counts, liver and kidney function, inflammatory markers), urine tests, and sometimes specific tests related to the investigational drug (e.g., hepatitis, HIV screening).

• Other Diagnostic Tests: Depending on the trial, you might undergo an electrocardiogram (ECG), vital signs measurements, or other specialized tests.

• Confirmation of Diagnosis: The study physician will confirm your HS diagnosis and severity based on their assessment and study-specific criteria.

• Concrete Example: During screening, the physician might use the Hurley Staging system (e.g., “You appear to be Hurley Stage II, which is within the trial’s specified range”) or the HS-PGA (e.g., “Your HS-PGA score is 3, confirming moderate HS”). They will also confirm there are no contraindications from your lab results.

Preparing for Your Screening Visit

• Actionable Tip:

  • Bring Documentation: Bring any relevant medical records, especially those pertaining to your HS diagnosis, previous treatments, and any significant medical conditions.

  • List All Medications: Have a complete, up-to-date list of all prescription and over-the-counter medications, supplements, and herbal remedies you are taking, including dosages and frequency.

  • Be Honest and Thorough: Provide accurate information during all assessments. Withholding information, even seemingly minor details, could impact your safety or the study’s validity.

  • Ask Questions: If any procedure or test is unclear, ask for an explanation.

Step 6: Participation and Ongoing Monitoring

Once you’ve successfully passed screening and are officially enrolled, you’ll begin the active participation phase of the trial. This involves adhering to the study protocol and regular monitoring by the research team.

Adhering to the Study Protocol

• Taking Study Medication/Undergoing Procedures: Follow instructions precisely regarding dosage, frequency, and administration of the investigational drug. If it’s a procedural trial, attend all scheduled sessions.

• Maintaining a Diary/Log: Many trials require participants to keep a diary of symptoms, medication times, or any side effects experienced.

  • Concrete Example: “Please record your daily pain score (0-10) and any new or worsening HS lesions in the provided diary.”
• Attending Scheduled Visits: These visits are crucial for monitoring your health, assessing the treatment’s effectiveness, and identifying any side effects.
  • Concrete Example: “Your next visit is in 2 weeks for a physical exam, blood draw, and review of your symptom diary.”

Ongoing Monitoring and Safety

Your safety is paramount throughout the trial. The research team will closely monitor you for any adverse events (side effects) and treatment response.

• Reporting Side Effects: Immediately report any new or worsening symptoms, discomforts, or unusual reactions to the research team, no matter how minor they seem.
  • Actionable Tip: If you experience an unexpected headache, rash, or fatigue, call the study coordinator. Don’t wait until your next scheduled visit.
• Regular Assessments: Consistent physical exams, lab tests, and questionnaires will track your progress and safety.

• Investigator Oversight: The principal investigator (PI) and sub-investigators (study doctors) will review your data, adjust treatment if necessary (within protocol guidelines), and ensure your well-being.

• Data Collection: All information gathered, from your symptoms to lab results, is meticulously recorded to contribute to the study’s findings.

Your Rights as a Participant

• Right to Withdraw: You can withdraw from the study at any time, for any reason, without penalty. Your medical care will not be affected.

• Right to Information: You have the right to be informed of any new information that might affect your willingness to continue participating.

• Confidentiality: Your personal health information will be kept confidential.

Step 7: Post-Trial Considerations

What happens after the trial concludes is an important consideration, especially for chronic conditions like HS.

Follow-Up Period

Many trials include a post-treatment follow-up period to monitor long-term effects and gather additional safety data. This might involve fewer visits, primarily for observation.

• Actionable Example: “After the 24-week treatment period, you will have follow-up visits at Week 30 and Week 36 to assess long-term safety.”

Access to Investigational Treatment

If the investigational drug proves successful, gaining continued access after the trial can vary.

• Open-Label Extension Studies: If the drug shows promise, the sponsor might offer an open-label extension study where all participants, including those who were on placebo, can receive the active drug.
  • Actionable Tip: During the informed consent process, ask, “If the trial drug is effective, will there be an option for continued access after the study ends, such as an open-label extension?”
• Expanded Access (Compassionate Use): In rare cases, for serious conditions with no other treatment options, patients might be able to access the investigational drug through expanded access programs, even if it’s not yet FDA-approved. This is highly regulated and not guaranteed.

• Commercial Availability: Ultimately, if the drug is approved by regulatory bodies (e.g., FDA in the US, EMA in Europe), it will become commercially available through prescription.

Receiving Study Results

You have a right to be informed about the overall results of the trial.

• Actionable Tip: Ask the research team how and when you can expect to receive the study results. They might offer to send you a summary, or you can often find published results on ClinicalTrials.gov once available.

Maximizing Your Trial Experience

Participating in an HS clinical trial is a significant commitment. To ensure you have the best possible experience and contribute effectively:

• Maintain Open Communication: Be proactive in communicating with the research team. Report all symptoms, concerns, and questions promptly. They are there to support you.

• Keep Accurate Records: Maintain your own personal log of visits, medications, and any changes in your condition. This can be helpful for your own understanding and for discussions with the study team.

• Understand Your Role: Remember you are a vital partner in the research. Your participation helps advance medical knowledge and potentially brings new treatments to others.

• Don’t Be Afraid to Advocate: If you feel uncomfortable or have persistent questions that aren’t being adequately addressed, voice your concerns. You have rights as a participant.

• Connect with Support Networks: Discussing your experience with others who have participated in clinical trials or are living with HS can provide emotional support and practical advice.

Conclusion

Embarking on the journey of an HS clinical trial is a powerful step, offering the potential for improved health outcomes and a profound contribution to the understanding and treatment of Hidradenitis Suppurativa. By systematically utilizing online resources, consulting with healthcare professionals, diligently reviewing eligibility criteria, and engaging fully in the informed consent process, you can confidently navigate this path. Your active participation is not merely about finding a new treatment for yourself; it’s about becoming a part of the solution, pushing the boundaries of medical science, and offering hope to countless individuals worldwide who grapple with HS. The path to better HS care is paved by those willing to step forward, and with this guide, you are now equipped to be one of them.