Brief Summary

Cannabis, in addition to its psychotropic properties, could have anti-inflammatory and immunomodulatory effects. Phytocannabinoids (pCBs) are a group of molecules naturally secreted by the cannabis plant. The major pCBs are cannabidiol (CBD) and Δ9-tetrahydrocannabinol Δ9 (THC). Only THC has psychotropic effects, which CBD does not have. Alongside these two main components, there is a wide variety of other molecules, such as other pCBs and terpenes which could increase the effects on immune system through synergistic interactions between these different compounds ("entourage effect").In vivo, pCBs essentially interfere with the endocannabinoid system, acting on many ubiquitous receptors, present on a significant number of different cell types. Numerous published studies show that pCBs have immunomodulatory and anti-inflammatory properties by acting on several of these receptors, whether through modulation of the immune response of different cell types, effects on cytokine networks, reduction of innate and adaptive responses and/or impact on cell survival or death (autophagy, proliferation/ apoptosis). The Immune-Mediated Inflammatory Diseases (IMIDs) affect 5 to 7% of the general population in Western countries, involve different organs (joints, skin, digestive tract) but share the same inflammatory mechanisms resulting from a dysregulation of the immune response. Our research focuses on the identification of the most effective phytochemical profile of pCBs, allowing an optimal effect on chronic inflammatory pathologies of interest among immune-mediated chronic inflammatory diseases (IMIDs). The pCB-IMIDs project is therefore part of an innovative translational project, around new therapeutic applications of medical cannabis (CannAppIMIDs). In our study, we will include 100 patients with one of IMIDs among Rheumatoid Arthritis, spondylarthritis, psoriatic arthritis, Sjogren disease and systemic lupus, at different stage and with different treatments. After patient's consent we will collect for research purposes an additional 40 ml of blood during a routine care blood test. Mononuclear and polynucleated blood cells will be exposed in vitro to different full-spectrum pCB extracts (full spectrum extract) including a CBD dominant and low THC extract (\<0.2%), 1 dominant THC extract, 1 balanced THC/CBD extract and 1 dominant CBG extract. In this cross-sectional study, our objective will be to assess the biological effects of different pCB compositions on inflammatory profiles (concentrations of pro and anti-inflammatory cytokines and chemokines) and modulations of expression profiles (autophagy, apoptosis, and cannabinoid receptor expression profile).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

100

participants targeted

Target at P50-P75 for all trials

Timeline

10mo left

Started Apr 2025

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 years study duration

Study Progress59%

Apr 2025Apr 2027

First Submitted

Initial submission to the registry

February 13, 2025

Completed

11 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed

2 months until next milestone

Study Start

First participant enrolled

April 10, 2025

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2027

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

February 13, 2025

Last Update Submit

December 22, 2025

Conditions

Arthritis, Psoriatic Inflammatory Bowel Diseases Sjogren's Syndrome Lupus Erythematosus, Systemic Inflammatory Disorder of Immune System Spondylitis, Ankylosing Arthritis, Rheumatoid

Keywords

IMIDsphytocanabinoidinflammatory effectblood cells

Outcome Measures

Primary Outcomes (2)

The primary outcome is to evaluate the biological effect of exposure of blood cells from patients suffering from IMID to different varieties of pCB extracts on the inflammatory profile.
The initial inflammatory profiles of patients will be established by evaluations at the transcriptomic and protein level.
One sample at inclusion for all patients
The primary outcome is to evaluate the immunological effect of exposure of blood cells from patients suffering from IMID to different varieties of pCB extracts on the inflammatory profile.
In plasma, the concentrations of cytokines and chemokines associated with inflammation, pro (mainly TNF-α IFN-α, but for instance also IL6, IL8, and IL1-β) and anti-inflammatory (for example IL-10) will be quantified in Multiplexed (34-plex type) or conventional ELISA. The level of expression of the corresponding transcripts, produced by the sorted subpopulations (cellular targets: polymorphonuclear, CD14+ monocyte, CD19+ B lymphocytes, CD4+ T4 lymphocytes and CD8+ T8 lymphocytes) will subsequently be reported by BRB-Seq \[13\] and/or by droplet RT-PCR (RT-ddPCR) assays. This quantification technique is reproducible, requires little starting biological material and is very efficient in detecting small quantities.
One sample at inclusion for all patients

Secondary Outcomes (3)

Inflammatory and autophagic/apoptotic transcripts, as well as transcripts of the main phytocannabinoid receptors in subpopulations of sorted blood cells.
One sample at inclusion for all patients
The main phytocannabinoid receptors in blood cells
One sample at inclusion for all patients
The main autophagy genes and apoptosis genes such as caspases
One sample at inclusion for all patients

Study Arms (5)

Rheumatoid polyarthritis

10 patients without, 10 patients under basic treatment (csDMARDs\*) and 10 patients under biotherapy or targeted therapy