A PHASE 3 MULTI-CENTER MULTI-NATIONAL RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED INDUCTION AND MAINTENANCE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Eoe
  • Age: Between 12 - 75 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants who have a body weight of = 40 kg (88.2 lb)
    2. Have histologic evidence of Eosinophilic Esophagitis (EoE)
    3. Have symptoms of dysphagia
    4. Must have previously received an adequate trial of proton-pump inhibitor (PPI) medication that did not provide complete response to EoE, or remains symptomatic with continued use
    5. Participants must either (1) be naïve or have had an adequate response to corticosteroid therapy (ie, classified as Steroid Responders/Naïve) or (2) have had an inadequate response to corticosteroid therapy and is not considered to be a candidate for continued corticosteroid therapy, or is intolerant to corticosteroid therapy
    6. Participants must agree to maintain a stable diet (including any food elimination diet for the treatment of food allergy or EoE) from the first Screening Visit and throughout the duration of the study, and participants must have maintained a stable diet for at least 4 weeks prior to the first Screening Visit
    7. Participants currently receiving inhaled corticosteroids, leukotriene receptor antagonists (eg, montelukast), or mast cell stabilizers (eg, cromolyn sodium) for indications other than EoE, or medium potency topical corticosteroids (eg, mometasone furoate cream or lotion) for dermatologic conditions, must maintain stable doses/regimens for at least 4 weeks prior to the first Screening Visit and regimens must remain stable throughout the duration of the study
    8. Female participants of childbearing potential must agree to practice a highly effective method of contraception
    9. Participants are willing to receive weekly SC injections throughout the study
    10. Participants must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted
    11. Participants are willing and able to adhere to the study visit schedule and other protocol requirements

You may not be eligible for this study if the following are true:

    1. Participants have clinical or endoscopic evidence of the presence of any other disease that may interfere with or affect the histologic, endoscopic, and clinical symptom endpoints for this study
    2. Participants demonstrate presence of esophageal varices
    3. Participants have a known active Helicobacter pylori infection and/or is currently being treated for this condition
    4. Participants have evidence of a severe endoscopic structural abnormality in the esophagus
    5. Participants had esophageal dilation for symptom relief
    6. Participants demonstrate evidence of immunosuppression or is receiving systemic immunosuppressive or immunomodulating drugs
    7. Participants are currently receiving systemic or swallowed topical corticosteroid medication
    8. Participants are currently receiving a high potency topical corticosteroid for dermatologic use
    9. Participants are currently receiving a leukotriene receptor antagonist (eg, montelukast) or mast cell stabilizer (eg, cromolyn sodium) for the indication of EoE
    10. Participants are currently successfully treated for EoE with dietary modifications (eg, food elimination diet) and is able to fully adhere to the diet resulting in a complete response to EoE
    11. Participants have received oral or sublingual immunotherapy within 6 months of the first Screening Visit; any use will be prohibited during the study
    12. Participants are receiving concurrent treatment with another IP
    13. Participants have received a live attenuated vaccine within one month prior to the first Screening Visit or anticipates the need to be vaccinated with a live attenuated vaccine during the course of the study
    14. Participants have previously received CC-93538 treatment (formerly known as RPC4046 and ABT-308) through participation in the Phase 2 Study, RPC02-201, or any Phase 1 clinical study
    15. Participants have any other disease that would make conduct of the protocol or interpretation of the study results difficult or that would put the prospective participant at risk by participating in the study
    16. Participants have liver function impairment
    17. Participants have an active parasitic/helminthic infection or a suspected parasitic/helminthic infection
    18. Participants have an ongoing infection
    19. Participants had a previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening
    20. Participants have known hereditary fructose intolerance (HFI)
    21. Pregnant or lactating
    22. Participants have a history of idiopathic anaphylaxis or a major immunologic reaction (such as anaphylactic reaction, anaphylactoid reaction, or serum sickness) to an immunoglobulin G (IgG) containing agent.
    23. Participants have a history of cancer or lymphoproliferative disease,
    24. Participants have a history of alcohol or drug abuse within 5 years prior to initiation of screening
    25. Participants have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study
    26. Participants have any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study
    27. Participants have any condition that confounds the ability to interpret data from the study



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