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NCT06910358RECRUITINGIRB Ready

Study of Bitopertin in Participants With EPP or XLP (APOLLO)

(APOLLO)

Sponsored by Disc Medicine, Inc

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 150 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The goal of this clinical trial is to learn if bitopertin works and is safe to treat EPP or XLP in participants 12 years or older. The main questions it aims to answer are: * Whether bitopertin increases pain-free sunlight exposure after 6 months of treatment in participants with EPP or XLP. * How PPIX concentration levels change from before bitopertin treatment to after 6 months of treatment. Researchers will compare bitopertin to a placebo look-alike substance that contains no drug.

Who Can Participate

Inclusion Criteria

Aged 12 years or older at the time of study consent. 2. Diagnosis of EPP or XLP, based on medical history by ferrochelatase (FECH) or aminolevulinic acid synthase 2 (ALAS2) genotyping or by biochemical porphyrin analysis. 3. Minimum daily Sun Exposure Diary compliance โ‰ฅ85% on Days -14 through Day -1, inclusive, during screening, and at least 1 successfully completed Sun Exposure Challenge (adults only, as this assessment is optional for adolescents) or historical recall of time to prodrome 4. Body weight โ‰ฅ32 kg (ages 12 to \<18 years), body mass index โ‰ฅ18.5 kg/m2 (ages โ‰ฅ18 years) at screening. 5. Washout of at least 2 months prior to screening of afamelanotide and dersimelagon, if applicable. 6. Aspartate aminotransferase and alanine transaminase \<3ร— upper limit of normal (ULN)and total bilirubin \<2ร— ULN (unless documented Gilbert syndrome) at screening. Albumin \>lower limit of normal (LLN). 7. Willing to practice highly effective methods of birth control (bo

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

150 participants

โšง

Gender

ALL

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Sponsor

Disc Medicine, Inc

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Huntington Beach

California

Location available
View Huntington Beach location page
RECRUITING

San Francisco

California

Location available
View San Francisco location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Boston

Massachusetts

Location available
View Boston location page
RECRUITING

Boston

Massachusetts

Location available
View Boston location page
RECRUITING

Detroit

Michigan

Location available
View Detroit location page
RECRUITING

New York

New York

Location available
View New York location page
RECRUITING

Winston-Salem

North Carolina

Location available
View Winston-Salem location page
RECRUITING

Columbus

Ohio

Location available
View Columbus location page

๐Ÿ“ And 2 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Erythropoietic Protoporphyria Treatment in Huntington Beach?

Join others in California exploring innovative treatment options through clinical research

Erythropoietic Protoporphyria Treatment Options in Huntington Beach, California

If you're searching for Erythropoietic Protoporphyria treatment in Huntington Beach, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Huntington Beach, San Francisco, Miami and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Erythropoietic Protoporphyria. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 150 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Erythropoietic Protoporphyria?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Erythropoietic Protoporphyria

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Erythropoietic Protoporphyria Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06910358. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.