A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis
Condition: Psoriasis; Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: EDP1815; Placebo
Intervention description: EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria; Placebo oral capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multicenter, randomized, double-blind, placebo-controlled, parallel-cohort, dose-ranging study of participants with mild to moderate plaque psoriasis
Masking: Double (Participant, Investigator)
Enrollment: 249.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: PSO; mild psoriasis; moderate psoriasis; plaque psoriasis; psoriasis; EDP1815

Summary:

      This Phase 2 study has been designed to investigate the clinical safety and efficacy of
      EDP1815 and to identify an optimal dose in subjects with mild to moderate psoriasis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Males or females ≥18 and ≤70 years old at the time of informed consent.

          2. A documented diagnosis of plaque psoriasis for ≥6 months.

          3. Have mild to moderate plaque psoriasis with plaque covering body surface area (BSA) of
             ≥3% and ≤10% and meet both of the following additional criteria:

               1. PASI score of ≥6 and ≤15, and

               2. PGA score of 2 or 3.

        Key Exclusion Criteria:

          1. Have a diagnosis of non-plaque psoriasis.

          2. Plaque psoriasis restricted to scalp, palms, and soles only.

          3. Have received systemic immunosuppressive therapy (MTX, apremilast, azathioprine,
             cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and
             tacrolimus) within 4 weeks of first administration of study drug.

          4. Unresponsive to prior use of biologics (including, but not limited to, TNFα
             inhibitors, natalizumab, efalizumab, anakinra or agents that modulate B cells or T
             cells).

          5. If prior biologic therapy and responsive, participants must have been off therapy for
             at least 12 months prior to first administration of study drug.

          6. Have received phototherapy or any systemic medications/treatments that could affect
             psoriasis or PGA evaluation (including, but not limited to oral or injectable
             corticosteroids, retinoids, psoralens, sulfasalazine, hydroxyurea, or fumaric acid
             derivatives) within 4 weeks of first administration of study drug. This includes
             therapeutic doses of non-steroidal anti-inflammatory drugs such as ibuprofen, although
             intermittent as required use as an analgesic is permitted when required. Chronic use
             of low dose aspirin for cardiovascular protection is permitted.

          7. Currently receiving lithium, antimalarials, leflunomide, or IM gold, or have received
             lithium, antimalarials, IM gold, or leflunomide within 4 weeks of first administration
             of study drug.

          8. Have used topical medications/treatments that could affect psoriasis or PGA evaluation
             (including [but not limited to] high- and mid-potency corticosteroids, anthralin,
             calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen,
             trimethylpsoralens, picrolimus, and tacrolimus) within 2 weeks of the first
             administration of study drug. Topical unmedicated emollients and low-potency topical
             corticosteroids are not excluded.

          9. Gastrointestinal tract disease (eg, short-bowel syndrome, diarrhea-predominant
             irritable bowel syndrome) that could interfere with GI delivery and transit time.

         10. Active inflammatory bowel disease.

         11. Active infection requiring systemic antiviral or antimicrobial therapy that will not
             be completed prior to Day 1 (Visit 2).

         12. Have received live or live attenuated replicating vaccine within 6 weeks prior to
             screening or intend to have such a vaccination during the study.

         13. Clinically significant abnormalities in screening laboratory values that would render
             a participant unsuitable for inclusion (per investigator judgment).

         14. Known history of or positive test for HIV, or active infection with hepatitis C or
             chronic hepatitis B.

         15. History of clinically significant acute cardiac or cerebrovascular event within 6
             months before screening (includes stroke, transient ischemic attack, and coronary
             heart disease [angina pectoris, myocardial infarction, heart failure,
             revascularization procedures]).

         16. Current acute or chronic inflammatory disease other than psoriasis or psoriatic
             arthritis (eg, inflammatory bowel disease, rheumatoid arthritis, systemic lupus
             erythematosus). If a subject is off all treatment and is disease and has been symptom
             free for greater than 12 months, then the inflammatory disease is considered to be in
             remission and they may be enrolled.

         17. Hypersensitivity to P histicola or to any of the excipients.

         18. Active untreated mental or psychiatric disorder. Participants who are on stable dosing
             of medication for a mental or psychiatric disorder for at least 6 months before
             screening and whose treating physicians consider them to be mentally stable may be
             enrolled.

         19. Any major or minor GI surgery within 6 months of screening.

         20. Any major surgery within 6 months of screening.

         21. Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or
             carcinoma in situ of the cervix that has been successfully treated.

         22. Treatment with another investigational drug, biological agent, or device within 1
             month of screening, or 5 half-lives of investigational agent, whichever is longer.

         23. Initiating any OTC or prescription medication including vitamins, herbal supplements
             and nutraceuticals (eg, supplements including high doses of probiotics and prebiotics
             as usually found in capsules/tablets/powders), except acetaminophen/paracetamol and
             anti-histamines, within 14 days prior to baseline or anticipates change in dosage for
             the duration of the study period. Note that probiotic and prebiotic foods that contain
             low doses are allowed (eg, yoghurt, kefir, kombucha, however, supplements containing
             high doses of probiotics and prebiotics are not allowed at any point during the study.