Last reviewed · How we verify

NCT03155945

Tolerability, Pharmacokinetics, and Efficacy of APD371 in Participants With Crohn's Disease Experiencing Abdominal Pain

Completed Phase 2 Results posted Last updated 2 November 2021
What this trial tests

Phase 2 trial testing Olorinab in Crohn's Disease in 14 participants. Completed in 10 September 2018.

Timeline
19 July 2017
Primary endpoint
10 September 2018
10 September 2018

Quick facts

Lead sponsorArena Pharmaceuticals
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment14
Start date19 July 2017
Primary completion10 September 2018
Estimated completion10 September 2018
Sites7 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Arena Pharmaceuticals — full company profile →

Who can join

Adults 18 to 80, any sex, with Crohn's Disease or Abdominal Pain. 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.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Primary · Up to approximately 12 weeks

TEAE was defined as an adverse event (AE) that occurred after first dose of olorinab. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events. Safety was assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.

TEAEs
GroupValue95% CI
Olorinab 25 mg TID4
Olorinab 100 mg TID6
SAEs
GroupValue95% CI
Olorinab 25 mg TID0
Olorinab 100 mg TID1

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to approximately 12 weeks. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Olorinab 25 mg TID
Serious: 0/6 (0%)
Deaths: 0/6
Olorinab 100 mg TID
Serious: 1/8 (13%)
Deaths: 0/8

Serious adverse events (2 terms)

ReactionSystemOlorinab 25 mg TIDOlorinab 100 mg TID
Interstitial lung diseaseRespiratory, thoracic and mediastinal disorders
Acute interstitial pneumonitisRespiratory, thoracic and mediastinal disorders
Other adverse events (28 terms — click to expand)

ReactionSystemOlorinab 25 mg TIDOlorinab 100 mg TID
HypomagnesaemiaMetabolism and nutrition disorders
Pain in extremityMusculoskeletal and connective tissue disorders
ConjunctivitisInfections and infestations
GastroenteritisInfections and infestations
Lower respiratory tract infectionInfections and infestations
Oral herpesInfections and infestations
Pneumonia viralInfections and infestations
Upper respiratory tract infectionInfections and infestations
Drug hypersensitivityImmune system disorders
Fluid overloadMetabolism and nutrition disorders
HypokalaemiaMetabolism and nutrition disorders
DizzinessNervous system disorders
HeadacheNervous system disorders
SomnolenceNervous system disorders
HypotensionVascular disorders
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders
DiarrhoeaGastrointestinal disorders
Dry mouthGastrointestinal disorders
NauseaGastrointestinal disorders
Muscle spasmsMusculoskeletal and connective tissue disorders
ProteinuriaRenal and urinary disorders
Injection site extravasationGeneral disorders
Non-cardiac chest painGeneral disorders
Blood lactic acid increasedInvestigations
C-reactive protein decreasedInvestigations
C-reactive protein increasedInvestigations
Fibrin D dimer increasedInvestigations
Animal biteInjury, poisoning and procedural complications

Most-reported serious reactions: Interstitial lung disease, Acute interstitial pneumonitis.

Data from ClinicalTrials.gov NCT03155945 adverse events section.

Sponsor's own description

The purpose of this randomized, open-label, parallel, phase 2a study is to determine the tolerability, pharmacokinetics, and efficacy of olorinab in participants with Crohn's disease experiencing abdominal pain.

Publications & conference data

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

  1. A Guide to Targeting the Endocannabinoid System in Drug Design.
    Stasiulewicz A, Znajdek K, Grudzień M, Pawiński T, et al · · 2020 · cited 76× · PMID 32316328 · DOI 10.3390/ijms21082778
  2. Cannabis, Cannabinoids, and the Endocannabinoid System-Is there Therapeutic Potential for Inflammatory Bowel Disease?
    Ambrose T, Simmons A. · · 2019 · cited 52× · PMID 30418525 · DOI 10.1093/ecco-jcc/jjy185
  3. Interventions for the management of abdominal pain in Crohn's disease and inflammatory bowel disease.
    Sinopoulou V, Gordon M, Akobeng AK, Gasparetto M, et al · · 2021 · cited 40× · PMID 34844288 · DOI 10.1002/14651858.cd013531.pub2
  4. The Impact of the CB<sub>2</sub> Cannabinoid Receptor in Inflammatory Diseases: An Update.
    Rakotoarivelo V, Mayer TZ, Simard M, Flamand N, et al · · 2024 · cited 34× · PMID 39064959 · DOI 10.3390/molecules29143381
  5. Olorinab (APD371), a peripherally acting, highly selective, full agonist of the cannabinoid receptor 2, reduces colitis-induced acute and chronic visceral hypersensitivity in rodents.
    Castro J, Garcia-Caraballo S, Maddern J, Schober G, et al · · 2022 · cited 28× · PMID 33863856 · DOI 10.1097/j.pain.0000000000002314
  6. Safety, Pharmacokinetics, and Efficacy of Olorinab, a Peripherally Acting, Highly Selective, Full Agonist of the Cannabinoid Receptor 2, in a Phase 2a Study of Patients With Chronic Abdominal Pain Associated With Crohn's Disease.
    Yacyshyn BR, Hanauer S, Klassen P, English BA, et al · · 2021 · cited 22× · PMID 36777064 · DOI 10.1093/crocol/otaa089
  7. Toward an effective peripheral visceral analgesic: responding to the national opioid crisis.
    Camilleri M. · · 2018 · cited 14× · PMID 29470146 · DOI 10.1152/ajpgi.00013.2018
  8. Molecular mechanisms of pain in acute pancreatitis: recent basic research advances and therapeutic implications.
    Wu Y, Han C, Luo R, Cai W, et al · · 2023 · cited 9× · PMID 38188196 · DOI 10.3389/fnmol.2023.1331438

Verify or expand the search:

Other trials of Olorinab

Trials testing the same drug.

Other recruiting trials for Crohn's Disease

Currently open trials in the same condition.

Other Arena Pharmaceuticals trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03155945.

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