NCT03398837 (RESOLVE-1) is a Phase 3 clinical trial of Lenabasum 5 mg in Diffuse Cutaneous Systemic Sclerosis, sponsored by Corbus Pharmaceuticals Inc..

Who is sponsoring NCT03398837?

NCT03398837 is sponsored by Corbus Pharmaceuticals Inc..

What drugs are being tested in NCT03398837?

Interventions in NCT03398837: Lenabasum 5 mg, Lenabasum 20 mg, Placebo oral capsule.

What condition does NCT03398837 study?

NCT03398837 studies Diffuse Cutaneous Systemic Sclerosis.

Is NCT03398837 still recruiting?

NCT03398837 is currently terminated. Last updated 29 March 2021.

Last reviewed 2021-03-29 · How we verify

NCT03398837: RESOLVE-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

Terminated Phase 3 Last updated 29 March 2021

What this trial tests

Phase 3 trial testing Lenabasum 5 mg in Diffuse Cutaneous Systemic Sclerosis in 365 participants. Terminated before completion.

Timeline

18 December 2017

Primary endpoint
27 May 2020

21 December 2020

Quick facts

Lead sponsor	Corbus Pharmaceuticals Inc.
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	365
Start date	18 December 2017
Primary completion	27 May 2020
Estimated completion	21 December 2020
Sites	74 locations across Japan, Netherlands, United Kingdom, Israel, Germany, Poland, South Korea, Canada

Drugs / interventions tested

Lenabasum 5 mg — full drug profile →
Lenabasum 20 mg — full drug profile →
Placebo oral capsule

Conditions studied

Diffuse Cutaneous Systemic Sclerosis — all drugs for Diffuse Cutaneous Systemic Sclerosis →

Sponsor

Corbus Pharmaceuticals Inc. — full company profile →

Who can join

18 and older, any sex, with Diffuse Cutaneous Systemic Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.

Publications & conference data

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

Interstitial lung disease associated with systemic sclerosis (SSc-ILD).
Cottin V, Brown KK. · · 2019 · cited 179× · PMID 30658650 · DOI 10.1186/s12931-019-0980-7
Cannabinoid Signaling in the Skin: Therapeutic Potential of the "C(ut)annabinoid" System.
Tóth KF, Ádám D, Bíró T, Oláh A. · · 2019 · cited 137× · PMID 30845666 · DOI 10.3390/molecules24050918
Unraveling SSc Pathophysiology; The Myofibroblast.
van Caam A, Vonk M, van den Hoogen F, van Lent P, et al · · 2018 · cited 118× · PMID 30483246 · DOI 10.3389/fimmu.2018.02452
National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2020 Highly morbid forms report.
Wolff D, Radojcic V, Lafyatis R, Cinar R, et al · · 2021 · cited 109× · PMID 34217703 · DOI 10.1016/j.jtct.2021.06.001
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
Cannabinoids as Key Regulators of Inflammasome Signaling: A Current Perspective.
Suryavanshi SV, Kovalchuk I, Kovalchuk O. · · 2020 · cited 54× · PMID 33584697 · DOI 10.3389/fimmu.2020.613613
Innate Immunity in Systemic Sclerosis Fibrosis: Recent Advances.
Laurent P, Sisirak V, Lazaro E, Richez C, et al · · 2018 · cited 43× · PMID 30083163 · DOI 10.3389/fimmu.2018.01702
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

Verify or expand the search:

Other trials of Lenabasum 5 mg

Trials testing the same drug.

NCT03813160 — Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis · Phase 3 · completed
NCT03451045 — Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis · Phase 2 · completed

Other recruiting trials for Diffuse Cutaneous Systemic Sclerosis

Currently open trials in the same condition.

NCT06925542 — A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease · Phase 1 · recruiting
NCT06375005 — Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis · Phase 2 · recruiting
NCT06470048 — A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis · Phase 2 · recruiting
NCT05149768 — Open Label Extension Study of Brentuximab Vedotin in Early dcSSc · Phase 2 · recruiting
NCT05270668 — Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With I · Phase 2 · active not recruiting

Other Corbus Pharmaceuticals Inc. trials

Trials by the same sponsor.

NCT07310901 — A 2-part, Phase 1b Clinical Study Designed to Evaluate the Safety, PK, and Efficacy of CRB-913 in Participants With Obes · Phase 1 · recruiting
NCT06603844 — First-in-human Study of CRB-601-01 to Treat Patients With Advanced Solid Tumor. · Phase 1, PHASE2 · recruiting
NCT06265727 — A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors · Phase 1, PHASE2 · recruiting
NCT03813160 — Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis · Phase 3 · completed
NCT03451045 — Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03398837 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Corbus Pharmaceuticals Inc.
Last refreshed: 29 March 2021

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/NCT03398837.

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