NCT03626311 (ORKIDS) is a NA clinical trial of AKBM-3031 in Systemic Lupus Erythematosus (SLE), sponsored by Aker BioMarine Human Ingredients AS.

Who is sponsoring NCT03626311?

NCT03626311 is sponsored by Aker BioMarine Human Ingredients AS.

What drugs are being tested in NCT03626311?

Interventions in NCT03626311: AKBM-3031, Placebo.

What condition does NCT03626311 study?

NCT03626311 studies Systemic Lupus Erythematosus (SLE).

Is NCT03626311 still recruiting?

NCT03626311 is currently completed. Last updated 12 October 2021.

Last reviewed 2021-10-12 · How we verify

NCT03626311: ORKIDS

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

Omega-3 Replacement With Krill Oil in Disease Management of SLE

Completed NA Last updated 12 October 2021

What this trial tests

NA trial testing AKBM-3031 in Systemic Lupus Erythematosus (SLE) in 76 participants. Completed in 21 August 2021.

Timeline

23 October 2018

Primary endpoint
21 August 2021

21 August 2021

Quick facts

Lead sponsor	Aker BioMarine Human Ingredients AS
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	supportive care
Enrollment	76
Start date	23 October 2018
Primary completion	21 August 2021
Estimated completion	21 August 2021
Sites	19 locations across Canada, United States

Drugs / interventions tested

AKBM-3031
Placebo

Conditions studied

Systemic Lupus Erythematosus (SLE) — all drugs for Systemic Lupus Erythematosus (SLE) →

Sponsor

Aker BioMarine Human Ingredients AS

Who can join

18 and older, any sex, with Systemic Lupus Erythematosus (SLE). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A randomized, double-blind controlled, multicenter study in SLE patients given AKBM-3031or placebo for 24 weeks (randomized period) and followed by an open label extension (OLE) treatment with AKBM-3031 for the next 24 weeks. Patients will be maintained on stable doses of background medications, except for glucocorticoids. Decreases in doses of glucocorticoids will be encouraged during the first 20 weeks of both the randomized and open label extension portions of the trial. Stable doses of glucocorticoids and other background medications are required during weeks 20-22 and 44-48.If indicated by the PI, brief increases in corticosteroids are permitted during the first 20 weeks of both the blinded and open label extension portion of the trial. The increase in prednisone (or equivalent) dose is limited to 2X the back-ground level to a maximum of20 mg/day for a maximum of 1 week (7 days) or to a single administration of intravenous methylprednisolone or equivalent at a maximum dose of 500mg. Stable doses of glucocorticoids and other background medications are required during weeks 20-22 and 44-48

Publications & conference data

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

Validation of eight endotypes of lupus based on whole-blood RNA profiles.
Hubbard E, Bachali P, Grammer AC, Lipsky PE. · · 2025 · cited 4× · PMID 40368437 · DOI 10.1136/lupus-2025-001526
Correction of omega-3 fatty acid deficiency and improvement in disease activity in patients with systemic lupus erythematosus treated with krill oil concentrate: a multicentre, randomised, double-blind, placebo-controlled trial.
Salmon J, Wallace DJ, Rus V, Cox A, et al · · 2024 · cited 4× · PMID 39009356 · DOI 10.1136/lupus-2024-001201

Verify or expand the search:

Other recruiting trials for Systemic Lupus Erythematosus (SLE)

Currently open trials in the same condition.

NCT07447986 — To Evaluate the Efficacy and Safety of SG301 SC Injection in Systemic Lupus Erythematosus · Phase 2 · recruiting
NCT07490041 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA CAR-NK Cell Injection for the Treatment of Refr · EARLY_PHASE1 · recruiting
NCT07087912 — Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases · Phase 4 · recruiting
NCT07332481 — A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease · Phase 3 · recruiting
NCT06875960 — A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Dis · Phase 4 · recruiting

Other Aker BioMarine Human Ingredients AS trials

Trials by the same sponsor.

NCT05650294 — Uptake of an Omega-3 Oil in Healthy Adults · NA · completed
NCT04013945 — Study to Investigate the Effect of Superba Boost on the Skin. · NA · completed
NCT06584669 — Investigation of Krill Oil in Women with Premenstrual Syndrome · NA · 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 NCT03626311 (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 Aker BioMarine Human Ingredients AS
Last refreshed: 12 October 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/NCT03626311.

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