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NCT05439941
A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials
Phase 2 trial testing EDP1815 in Atopic Dermatitis in 287 participants. Terminated before completion.
25 May 2023
Quick facts
| Lead sponsor | Evelo Biosciences, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 287 |
| Start date | 6 June 2022 |
| Primary completion | 25 May 2023 |
| Estimated completion | 7 June 2023 |
| Sites | 54 locations across Germany, Poland, Canada, Bulgaria, Australia, United States |
Drugs / interventions tested
- EDP1815
Conditions studied
- Atopic Dermatitis — all drugs for Atopic Dermatitis →
Sponsor
Evelo Biosciences, Inc. — full company profile →
Who can join
Adults 18 to 76, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events (AEs) were collected from informed consent, during the treatment period (110 days on average) and through an additional 28 days after taking their last dose of study drug.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (2 terms)
| Reaction | System | Group 1 | Group 2 | Group 3 |
|---|---|---|---|---|
| Hypertension Exacerbation | Vascular disorders | — | — | — |
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | — | — | — |
Other adverse events (4 terms — click to expand)
| Reaction | System | Group 1 | Group 2 | Group 3 |
|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | — | — | — |
| COVID-19 | Infections and infestations | — | — | — |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — |
Most-reported serious reactions: Hypertension Exacerbation, Abortion Spontaneous.
Data from ClinicalTrials.gov NCT05439941 adverse events section.
Sponsor's own description
This is an Open-Label Extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of EDP1815 in participants with mild, moderate, and severe atopic dermatitis who have completed the treatment period of a prior clinical study ("parent study") with EDP1815. The current parent study of this protocol is the EDP1815-207 study; A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Cohort Study Investigating the Effect of EDP1815 in Participants for the Treatment of Mild, Moderate and Severe Atopic Dermatitis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05439941
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other trials of EDP1815
Trials testing the same drug.
- NCT05682222 — Evaluation of the Immunopharmacology of EDP1815 and EDP2939 · Phase 1 · completed
- NCT05121480 — A Study Investigating the Effect of EDP1815 in the Treatment of Mild, Moderate and Severe Atopic Dermatitis · Phase 2 · completed
- NCT04603027 — A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis · Phase 2 · completed
- NCT04488575 — Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With COVID-19 Infection · Phase 2 · terminated
- NCT04393246 — mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms · Phase 2, PHASE3 · completed
Other recruiting trials for Atopic Dermatitis
Currently open trials in the same condition.
- NCT07262983 — Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopi · Phase 1 · recruiting
- NCT07445919 — A Clinical Study to Evaluate SM17 for Atopic Dermatitis · Phase 2 · recruiting
- NCT07488065 — A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants · Phase 1 · recruiting
- NCT07467564 — The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatit · recruiting
- NCT07358156 — A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and E · Phase 1 · recruiting
Other Evelo Biosciences, Inc. trials
Trials by the same sponsor.
- NCT05682222 — Evaluation of the Immunopharmacology of EDP1815 and EDP2939 · Phase 1 · completed
- NCT05121480 — A Study Investigating the Effect of EDP1815 in the Treatment of Mild, Moderate and Severe Atopic Dermatitis · Phase 2 · completed
- NCT05066373 — Scintigraphy Study to Evaluate the Gastrointestinal Behavior of EDP1815 Oral Dosage Forms · Phase 1 · completed
- NCT04927195 — Study in Healthy Participants and Participants With Moderate Atopic Dermatitis & Optionally, Moderate Psoriasis, and/or · Phase 1 · completed
- NCT04603027 — A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05439941 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Evelo Biosciences, Inc.
- Last refreshed: 7 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05439941.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing