A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis

• Sponsor: Evelo Biosciences, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04603027
• Collaborator: (none)
• Enrollment: 225
• Locations: 29
• Arms: 3
• Actual Duration (Months): 14.5
• Patients Per Site: 7.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis; Plaque Psoriasis	Drug: EDP1815; Drug: Placebo	Phase 2

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-cohort, dose-ranging study of participants with mild to moderate plaque psoriasis. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 225 participants
• 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 psoriasisThis 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)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Cohort, Dose-Ranging Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis
• Actual Study Start Date: Sep 21, 2020
• Actual Primary Completion Date: Jul 2, 2021
• Actual Study Completion Date: Dec 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 75 subjects with mild to moderate psoriasis; 50 on EDP1815, 25 on placebo. Dose = 0.8 x 10^11 cells, capsule, once daily, 16 weeks	Drug: EDP1815; EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria; Drug: Placebo; Placebo oral capsule
Experimental: Cohort 2 75 subjects with mild to moderate psoriasis; 50 on EDP1815, 25 on placebo. Dose = 3.2 x 10^11 cells, capsule, once daily, 16 weeks	Drug: EDP1815; EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria; Drug: Placebo; Placebo oral capsule
Experimental: Cohort 3 75 subjects with mild to moderate psoriasis; 50 on EDP1815, 25 on placebo. Dose = 8.0 x 10^11 cells, capsule, once daily, 16 weeks	Drug: EDP1815; EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria; Drug: Placebo; Placebo oral capsule

Outcome Measures

Primary Outcome Measures

1. Mean percentage change in PASI [16 weeks]

   The efficacy of EDP1815 will be measured using the mean percentage change in Psoriasis Area and Severity Index Score (PASI) from baseline to week 16

Secondary Outcome Measures

1. Mean percentage change in PASI [12 weeks]

   The efficacy of EDP1815 will be measured using the mean percentage change from baseline in Psoriasis Area and Severity Index Score (PASI) from baseline at weeks 4, 8, and 12

2. Mean absolute change in PASI [16 weeks]

   The efficacy of EDP1815 will be measured using the mean absolute change from baseline in Psoriasis Area and Severity Index Score (PASI) from baseline at weeks 4, 8, 12, and 16

3. Achievement of PASI-50 [16 weeks]

   The efficacy of EDP1815 will be measured using the achievement of PASI-50 at weeks 4, 8, 12, and 16

4. Time to first achievement of PASI-50 [16 weeks]

   The efficacy of EDP1815 will be measured using the time to first achievement of PASI-50

5. Achievement of PASI-75 [16 weeks]

   The efficacy of EDP1815 will be measured using the achievement of PASI-75 at week 16

6. Achievement of PASI-90 [16 weeks]

   The efficacy of EDP1815 will be measured using the achievement of PASI-90 at week 16

7. Achievement of PASI-100 [16 weeks]

   The efficacy of EDP1815 will be measured using the achievement of PASI-100 at week 16

8. Achievement of PGA of 0 or 1 with a ≥2-point improvement from baseline [16 weeks]

   The efficacy of EDP1815 will be measured using the achievement of PGA of 0 or 1 with a ≥2-point improvement from baseline at Week 16 [PGA = Physician's Global Assessment]

9. Achievement of PGA of 0 [16 weeks]

   The efficacy of EDP1815 will be measured using the achievement of PGA of 0 at Week 16 [PGA = Physician's Global Assessment]

10. Mean percentage change in PGAxBSA [16 weeks]

    The efficacy of EDP1815 will be measured using the mean percentage change from baseline in PGA x BSA at Weeks 4, 8, 12, and 16. [PGA = Physician's Global Assessment, BSA = Body Surface Area]

11. Mean absolute change in PGAxBSA [16 weeks]

    The efficacy of EDP1815 will be measured using the mean absolute change from baseline in PGA x BSA at Weeks 4, 8, 12, and 16. [PGA = Physician's Global Assessment, BSA = Body Surface Area]

12. Mean percentage change in LSS [16 weeks]

    The efficacy of EDP1815 will be measured using the mean percentage change from baseline in LSS (Lesion Severity Score) at Weeks 4, 8, 12, and 16.

13. Mean absolute change in LSS [16 weeks]

    The efficacy of EDP1815 will be measured using the mean absolute change from baseline in LSS (Lesion Severity Score) at Weeks 4, 8, 12, and 16.

14. Mean percentage change in DLQI [16 weeks]

    The efficacy of EDP1815 will be measured using mean percentage change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 8, 12, and 16

15. Mean absolute change in DLQI [16 weeks]

    The efficacy of EDP1815 will be measured using the mean absolute change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 8, 12, and 16

16. Mean percentage change in mNAPSI [16 weeks]

    The efficacy of EDP1815 will be measured using the mean percentage change in mNAPSI total score (modified Nail Psoriasis Severity Index) from baseline at Weeks 4, 8, 12, and 16

17. Mean absolute change in mNAPSI [16 weeks]

    The efficacy of EDP1815 will be measured using the mean absolute change in mNAPSI total score (modified Nail Psoriasis Severity Index) from baseline at Weeks 4, 8, 12, and 16

18. Cumulative incidence of partial relapse [40 weeks]

    The efficacy of EDP1815 will be measured by calculating the cumulative incidence of partial relapse at Weeks 20, 24, 28, and 40

19. Cumulative incidence of complete relapse [40 weeks]

    The efficacy of EDP1815 will be measured by calculating the cumulative incidence of complete relapse at Weeks 20, 24, 28, and 40

20. Cumulative incidence of rebound [40 weeks]

    The efficacy of EDP1815 will be measured by calculating the cumulative incidence of rebound at Weeks 20, 24, 28, and 40

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

4. PASI score of ≥6 and ≤15, and

5. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Synexus Clinical Research US, Inc. - Santa Rosa	Santa Rosa	California	United States	95405
2	Synexus Clinical Research US, Inc. - Orlando	Orlando	Florida	United States	32806
3	Synexus Clinical Research US, Inc. - St. Petersburg	Saint Petersburg	Florida	United States	33781
4	ForCare Clinical Research	Tampa	Florida	United States	33624
5	Synexus Clinical Research US, Inc. - The Villages	The Villages	Florida	United States	32162
6	Synexus Clinical Research US, Inc. - Cincinnati	Cincinnati	Ohio	United States	45236
7	Oregon Medical Research Center PC	Portland	Oregon	United States	97223
8	Synexus Clinical Research US, Inc. - Anderson	Anderson	South Carolina	United States	29621
9	Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft	Budapest		Hungary	1036
10	Synexus Zalaegerszeg Magyarország Egészségügyi Kft	Zalaegerszeg		Hungary	8900
11	Synexus - Wroclaw	Wrocław	Dolnoslaskie	Poland	50-088
12	Synexus - Gdansk	Gdańsk	Pomorskie	Poland	80-382
13	Synexus - Gdynia	Gdynia	Pomorskie	Poland	81-537
14	Synexus - Poznan	Poznań	Wielkopolskie	Poland	60-702
15	Synexus - Czestochowa	Czestochowa		Poland	42-202
16	Synexus - Katowice	Katowice		Poland	40-040
17	Synexus - Warszawa	Warszawa		Poland	01-192
18	Synexus - Lodz	Łódź		Poland
19	Synexus - Thames Valley Clinical Research Centre	Reading	Berkshire	United Kingdom	RG2 0TG
20	MAC Clinical Research	Blackpool	Lancashire	United Kingdom	FY2 0JH
21	Synexus - Lancashire Clinical Research Centre	Chorley	Lancashire	United Kingdom	PR7 7NA
22	Synexus - Merseyside Clinical Research Centre	Waterloo	Liverpool	United Kingdom	L22 0LG
23	Medicine Evaluation Unit	Wythenshawe	Manchester	United Kingdom	M23 9QZ
24	MAC Clinical Research	Stockton-on-Tees	North Yorkshire	United Kingdom	TS17 6EW
25	MAC Clinical Research	Cannock	Staffordshire	United Kingdom	WS11 0BN
26	Synexus - Wales Clinical Research Centre	Cardiff	Wales	United Kingdom	CF15 9SS
27	MAC Clinical Research	Leeds	West Yorkshire	United Kingdom	LS10 1DU
28	Synexus - Scotland Clinical Research Centre	Glasgow		United Kingdom	G20 0SP
29	Synexus - Manchester Clinical Research Centre	Manchester		United Kingdom	M15 6SE

Sponsors and Collaborators

• Evelo Biosciences, Inc.

Investigators

• Principal Investigator: Benjamin Ehst, MD PhD, Oregon Medical Research Center
• Study Director: Douglas Maslin, MPhil MBBS, Evelo Biosciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Evelo Biosciences, Inc.
• ClinicalTrials.gov Identifier: NCT04603027
• Other Study ID Numbers: EDP1815-201
• First Posted: Oct 26, 2020
• Last Update Posted: Jan 10, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Evelo Biosciences, Inc.: PSO; mild psoriasis; moderate psoriasis; plaque psoriasis; psoriasis; EDP1815
• Additional relevant MeSH terms: Psoriasis

Study Results

No Results Posted as of Jan 10, 2022