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NCT04603027

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

Completed Phase 2 Results posted Last updated 19 December 2022
What this trial tests

Phase 2 trial testing EDP1815 in Psoriasis in 249 participants. Completed in 6 December 2021.

Timeline
21 September 2020
Primary endpoint
2 July 2021
6 December 2021

Quick facts

Lead sponsorEvelo Biosciences, Inc.
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment249
Start date21 September 2020
Primary completion2 July 2021
Estimated completion6 December 2021
Sites29 locations across United Kingdom, Poland, United States, Hungary

Drugs / interventions tested

Conditions studied

Sponsor

Evelo Biosciences, Inc. — full company profile →

Who can join

Adults 18 to 70, any sex, with Psoriasis or Plaque Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Percentage Change in PASI Primary · 16 weeks

The Psoriasis Area and Severity Index Score (PASI) is a physician assessment that combines the assessment of the severity of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease).The efficacy of EDP1815 will be measured using the mean percentage change in PASI from baseline to week 16.

GroupValue95% CI
All Placebo-14.39-22.66 – -5.52
Cohort 1 Active-20.37-31.65 – -9.47
Cohort 2 Active-22.73-33.08 – -11.88
Cohort 3 Active-23.49-34.18 – -12.12
Mean Percentage Change in PASI Secondary · 12 weeks

The Psoriasis Area and Severity Index Score (PASI) is a physician assessment that combines the assessment of the severity of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease). The efficacy of EDP1815 will be measured using the mean percentage change from baseline in PASI from baseline at weeks 4, 8, and 12.

GroupValue95% CI
All Placebo-19.24-26.17 – -11.57
Cohort 1 Active-21.84-31.85 – -12.91
Cohort 2 Active-22.57-31.32 – -13.05
Cohort 3 Active-19.13-28.77 – -9.83
Mean Absolute Change in PASI Secondary · 16 weeks

The Psoriasis Area and Severity Index Score (PASI) is a physician assessment that combines the assessment of the severity of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease). The efficacy of EDP1815 will be measured using the mean absolute change from baseline in PASI from baseline at weeks 4, 8, 12, and 16.

GroupValue95% CI
All Placebo-1.16-1.87 – -0.41
Cohort 1 Active-1.85-2.74 – -0.91
Cohort 2 Active-1.88-2.77 – -1.04
Cohort 3 Active-1.97-2.92 – -1.08
Achievement of PASI-50 Secondary · 16 weeks

The efficacy of EDP1815 will be measured using the achievement of PASI-50 at weeks 4, 8, 12, and 16. PASI-50 is defined by at least a 50% reduction from baseline in the PASI score.

GroupValue95% CI
All Placebo8
Cohort 1 Active11
Cohort 2 Active15
Cohort 3 Active10
Time to First Achievement of PASI-50 Secondary · 20 weeks

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

GroupValue95% CI
All Placebo160160 – NA
Cohort 1 ActiveNANA – NA
Cohort 2 ActiveNANA – NA
Cohort 3 Active146146 – 154
Achievement of PASI-75 Secondary · 16 weeks

The efficacy of EDP1815 will be measured using the achievement of PASI-75 at week 16. PASI-75 response is defined by at least a 75% reduction from baseline in the PASI score.

GroupValue95% CI
All Placebo2
Cohort 1 Active2
Cohort 2 Active4
Cohort 3 Active4
Achievement of PASI-90 Secondary · 16 weeks

The efficacy of EDP1815 will be measured using the achievement of PASI-90 at week 16.PASI-90 response is defined by at least a 90% reduction from baseline in the PASI score.

GroupValue95% CI
All Placebo0
Cohort 1 Active2
Cohort 2 Active2
Cohort 3 Active0
Achievement of PASI-100 Secondary · 16 weeks

The efficacy of EDP1815 will be measured using the achievement of PASI-100 at week 16. PASI-100 response is defined as achieving a complete resolution of all disease.

GroupValue95% CI
All Placebo0
Cohort 1 Active0
Cohort 2 Active0
Cohort 3 Active0
Achievement of PGA of 0 or 1 With a ≥2-point Improvement From Baseline Secondary · 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 \[PGA = Physician's Global Assessment\]. The National Psoriasis Foundation Psoriasis Score version of a PGA is calculated by averaging the total body erythema, induration, and desquamation scores. Erythema, induration, and desquamation will be scored on a 6-point scale, ranging from 0 (clear) to 5 (severe): the total PGA score is defined as the average of the erythema, induration, and desquamation scores. PGA score of 0 or 1 is defined as clear or almost clear of

GroupValue95% CI
All Placebo4
Cohort 1 Active4
Cohort 2 Active5
Cohort 3 Active5
Achievement of PGA of 0 Secondary · 16 weeks

The efficacy of EDP1815 will be measured using the achievement of PGA of 0 at Week 16 \[PGA = Physician's Global Assessment\]. The National Psoriasis Foundation Psoriasis Score version of a PGA is calculated by averaging the total body erythema, induration, and desquamation scores. Erythema, induration, and desquamation will be scored on a 6-point scale, ranging from 0 (clear) to 5 (severe): the total PGA score is defined as the average of the erythema, induration, and desquamation scores. PGA score of 0 or 1 is defined as clear or almost clear of psoriasis. A PGA 0 is defined as clear or no s

GroupValue95% CI
All Placebo1
Cohort 1 Active0
Cohort 2 Active0
Cohort 3 Active1
Mean Percentage Change in PGAxBSA Secondary · 16 weeks

\[PGA = Physician's Global Assessment, BSA = Body Surface Area\]. The National Psoriasis Foundation Psoriasis Score version of a static Physicians Global Asessment (PGA) is calculated by averaging the total body erythema, induration, and desquamation scores. Erythema, induration, and desquamation will be scored on a 6-point scale, ranging from 0 (clear) to 5 (severe): the total PGA score is defined as the average of the erythema, induration, and desquamation scores. Body surface area (BSA) measures the total area of the body affected by psoriasis. Psoriasis that occurs on less than 5 percent

GroupValue95% CI
All Placebo-0.05-13.65 – 12.74
Cohort 1 Active-9.13-25.84 – 7.91
Cohort 2 Active-3.04-19.15 – 12.26
Cohort 3 Active-17.16-33.23 – -1.18
Mean Absolute Change in PGAxBSA Secondary · 16 weeks

\[PGA = Physician's Global Assessment, BSA = Body Surface Area\]. The National Psoriasis Foundation Psoriasis Score version of a static Physicians Global Asessment (PGA) is calculated by averaging the total body erythema, induration, and desquamation scores. Erythema, induration, and desquamation will be scored on a 6-point scale, ranging from 0 (clear) to 5 (severe): the total PGA score is defined as the average of the erythema, induration, and desquamation scores. Body surface area (BSA) measures the total area of the body affected by psoriasis. Psoriasis that occurs on less than 5 percent

GroupValue95% CI
All Placebo-0.01-2.68 – 2.41
Cohort 1 Active-2.67-5.77 – 0.60
Cohort 2 Active-0.84-3.93 – 2.06
Cohort 3 Active-3.54-6.58 – -0.29

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event (AE) data were collected over a period of 20 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

All Placebo
Serious: 0/83 (0%)
Deaths: 0/83
Cohort 1 Active
Serious: 1/56 (2%)
Deaths: 0/56
Cohort 2 Active
Serious: 0/55 (0%)
Deaths: 0/55
Cohort 3 Active
Serious: 1/55 (2%)
Deaths: 0/55

Serious adverse events (2 terms)

ReactionSystemAll PlaceboCohort 1 ActiveCohort 2 ActiveCohort 3 Active
COVID-19 PneumoniaInfections and infestations
Peptic Ulcer HemorrhageGastrointestinal disorders
Other adverse events (10 terms — click to expand)

ReactionSystemAll PlaceboCohort 1 ActiveCohort 2 ActiveCohort 3 Active
HeadacheNervous system disorders
Upper Respiratory Tract InfectionInfections and infestations
DiarrheaGastrointestinal disorders
Vaccination ComplicationInjury, poisoning and procedural complications
COVID-19Infections and infestations
DyspepsiaGastrointestinal disorders
Viral Upper Respiratory Tract InfectionInfections and infestations
Abdominal PainGastrointestinal disorders
FlatulenceGastrointestinal disorders
RashSkin and subcutaneous tissue disorders

Most-reported serious reactions: COVID-19 Pneumonia, Peptic Ulcer Hemorrhage.

Data from ClinicalTrials.gov NCT04603027 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Emerging Oral Therapies for the Treatment of Psoriasis: A Review of Pipeline Agents.
    Drakos A, Torres T, Vender R. · · 2024 · cited 21× · PMID 38258121 · DOI 10.3390/pharmaceutics16010111
  2. Clinical translation of anti-inflammatory effects of <i>Prevotella histicola</i> in Th1, Th2, and Th17 inflammation.
    Itano A, Maslin D, Ramani K, Mehraei G, et al · · 2023 · cited 12× · PMID 37215725 · DOI 10.3389/fmed.2023.1070433
  3. Gut microbiota and transcriptome dynamics in every-other-day fasting are associated with neuroprotection in rats with spinal cord injury.
    Wang J, Zhao X, Zhou R, Wang M, et al · · 2023 · cited 6× · PMID 37577426 · DOI 10.3389/fmicb.2023.1206909
  4. A randomized, double-blinded, phase 2 trial of EDP1815, an oral immunomodulatory preparation of <i>Prevotella histicola</i>, in adults with mild-to-moderate plaque psoriasis.
    Ehst BD, Strober B, Blauvelt A, Maslin D, et al · · 2024 · cited 3× · PMID 38813388 · DOI 10.3389/fmed.2024.1292406

Verify or expand the search:

Other trials of EDP1815

Trials testing the same drug.

Other recruiting trials for Psoriasis

Currently open trials in the same condition.

Other Evelo Biosciences, Inc. trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing