EBIO - Enthesitis Biopsy Study

NCT04887597 | Unknown Phase 4

• 1 other identifier: EBIO
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this Phase IV study is to determine the effect of secukinumab on total immune cell numbers obtaines by entheseal biopsy in the inflamed human entheses in patients with Psoriatic Arthritis. This is a single arm, single centre, prospective, open label study with secukinumab.

Conditions

Psoriatic Arthritis; Enthesitis; Biopsy

Keywords

Enthesitis; Imaging; Psoriatic Arthritis; Biopsy

Outcome Measures

Primary Outcomes (1)

• Percent of patients with reduction of total immune cell (PMN, M, T cells, B cells, ILC3, Mast cells) numbers by at least 50 percent in the enthesial tissue after 24 weeks of treatment with secukinumab

  To define the effect of IL-17A inhibition on total immune cell numbers (PMN, M, T cells, B cells, ILC3, Mast cells) in the inflamed human entheses.

  baseline and 6 months

Secondary Outcomes (10)

• Change in numbers of MPO+ neutrophils and CD11b+ positive macrophages in enthesial biopsies

  baseline and 6 months

• Enthesitis and osteitis in MRI (elbow/ankle) (yes/no)

  baseline and 6 months

• Enthesitis in ultrasound examination (elbow/ankle) (yes/no) greyscale and doppler

  baseline and 6 months

• Change in clinical enthesitis (SPARCC,LEI,MASES)

  baseline and 6 months

• Change in clinical arthritis (SJC;TJC; DAPSA)

  baseline and 6 months

Study Arms (1)

Secukinumab Treatment

EXPERIMENTAL

all patients receive Secukinumab as well as a biopsy before and after treatment

Drug: Secukinumab

Interventions

Secukinumab DRUG

The study is composed of a single arm receiving secukinumab for the duration of 6 months.

Secukinumab Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Any contraindications for the treatment with secukinumab
• Subjects requiring systemic anticoagulation therapy or suffering from coagulation disorders or any other condition which might interfere with enthesitis tissue sampling
• IBD (e.g. Crohn´s disease, ulcerative colitis)
• Investigational study drug within 4 weeks (or 5 half-lives, whichever is longer) prior to enrolment
• Patients taking high-potency opioid analgesics, including but not limited to, methadone, hydromorphone, and morphine
• Any contraindication or unwillingness to perform MRI
• Rheumatologic, inflammatory diseases, including but not limited to: AS, RA
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
• Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception
• Any underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, psychiatric, endocrine, cardiac, infectious or gastrointestinal conditions which in the opinion of the investigator immune-compromises the patient and/or places the patient at unacceptable risk for participation in a secukinumab therapy
• Active systemic infections during the last two weeks (exception: common cold) prior to enrolment.
• Evidence of tuberculosis infection as defined by either a positive purified protein derivative (PPD) skin test (the size of induration will be measured after 48-72 hours, and a positive result is defined as an induration of ≥ 5mm or according to local practice/guidelines), or a positive Quantiferon test. Patients with a positive test may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active tuberculosis. If presence of latent tuberculosis is established then treatment according to local country guidelines must have been initiated prior to enrolment.
• Infection with human immunodeficiency virus (HIV) Hepatitis B (HBV) or Hepatitis C (HCV)
• History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system (except for basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed), treated or untreated within the past 5 years prior to enrolment.
• History or evidence of ongoing alcohol or drug abuse, within the last six months prior to enrolment.

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University Hospital Erlangen, Department of Internal Medicine 3, Rheumatology and Immunology

Erlangen, Bavaria, 91054, Germany

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Markus Neurath, Prof

  Dean University Hospital Erlangen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open label interventional study in 10 patients with enthesitis in psoriasis arthritis (PsA). The study is composed of a single arm receiving secukinumab for the duration of 6 months.

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: May 14, 2021
• Study Start: March 18, 2019
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: January 28, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)