A study to investigate EDP2939 in healthy volunteers and participants with moderate psoriasis.

Phase 1

• Conditions: Moderate plaque psoriasis; MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2022-001631-82-PL
• Lead Sponsor: Evelo Biosciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-26
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

1. Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Informed consent will be obtained prior to any screening procedures and in accordance with national, local, and institutional guidelines.
2. Contraception:
A male participant with a female partner of child-bearing potential must meet the criteria for acceptable contraception as detailed in the protocol during the study and for a period of 90 days after the last dose. All male participants must refrain from donating sperm during this period. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
I. Not a woman of child-bearing potential, as defined in the protocol.
OR
II. A woman of child-bearing potential who agrees to follow the contraceptive guidance in the protocol during participation in this study, 28 days prior to the first dose and for at least 1 complete menstrual cycle (=30 days) after the last dose
3. Males or females aged 18 to 75 years, inclusive, at the time of signing the ICF.
4. Body mass index of 18 to 35 kg/m2 inclusive.
5. A documented diagnosis of plaque psoriasis, with a patient- or clinician-reported disease duration of at least 6 months prior to screening.
6. Have plaque psoriasis meeting all of the following criteria at screening and baseline:
a. PGA score of 3 (moderate), and
b. BSA =5% and =20%, and
c. PASI =5 and =20.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

Exclusion Criteria

1. Participant has GI tract disease that could interfere with the GI delivery and transit time of EDP2939.
2. Participant has an active infection or has had an infection requiring antibiotic treatment within 6 weeks prior to study intervention administration.
3. Infection with HIV, HBV, or HCV; or known to be positive for HCV RNA or HbsAg.
4. Participant has undergone major surgery within 3 months prior to screening or in whom major surgery is planned during study participation.
5. History of neoplastic disease within 5 years of screening except for basal or squamous cell
carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
6. History of hypersensitivity or allergies to Prevotella or Prevotella-containing probiotics or any excipients in the IMP, or has a history of hypersensitivity or allergies to capsule shells.
7. Participant has received live or live-attenuated vaccination within 6 weeks prior to screening or intends to have such a vaccination during the study. Non-live and non-replicating vaccines are permitted if administered at least 14 days before randomisation.
8. Participant has received any investigational drug or experimental procedure within 90 days prior to randomisation.
9. Previous participation in a clinical study of EDP1815.
10. History of drug abuse or current regular use of illicit drugs or a history of alcohol abuse within 1 year prior to screening.
11. Female participant who is pregnant, or plans to become pregnant during the study, or breastfeeding.
12. Male participant who intends to donate sperm during the course of this study and for a period of 90 days after the last dose.
13. Any other conditions, which, in the opinion of the investigator or sponsor, would make the participant unsuitable for inclusion.
14. Plaque psoriasis limited to the scalp/ hands / feet.
15. Psoriasis flare within 8 weeks prior to screening.
16. Evidence of dermatologic conditions that, would interfere with psoriasis evaluation or the assessment of treatment response.
17. Use of systemic immunosuppressive therapy, systemic medications that could affect psoriasis or its symptoms, or phototherapy within 28 days of randomisation.
18. Treatment with topical medications that could affect psoriasis within 14 days of randomisation. Such topical medications would include, but are not limited to: corticosteroids, topical vitamin D derivatives, retinoids, tazarotene, pimecrolimus, and tacrolimus. Unmedicated emollients and moisturisers are not excluded and may be used throughout the study (but should be withheld on the day of study visits at which skin assessments of psoriasis are made by the investigator (e.g. PASI).
19. Received any of the following:
- Any cell-depleting agent, including rituximab, within 6 months prior to randomisation, or until lymphocyte cell counts return to normal, whichever is longer.
- Any other biologic agent, within 6 months prior to randomisation.
- Any other investigational drug within 3 months to randomisation.
20. Screening laboratory values showing:
- ALT or AST >2xULN.
- Elevated serum creatinine, defined for women as serum creatinine =125 µmol/L (1.414 mg/dL) and for men, serum creatinine =135 µmol/L (1.527 mg/dL).
- Other clinically significant abnormalities in screening laboratory values that in the opinion of the investigator would make a participant unsuitable for inclusion in the study.
21. History of clinically significant acute cardiac or cerebrovascular even

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified