NCT02504645: LUPUZOR

A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus

Completed Phase 3 Results posted Last updated 10 April 2019

What this trial tests

Phase 3 trial testing IPP-201101 in Lupus Erythematosus, Systemic in 202 participants. Completed in 1 January 2018.

Timeline

1 March 2015

Primary endpoint
1 January 2018

1 January 2018

Quick facts

Lead sponsor	ImmuPharma
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	202
Start date	1 March 2015
Primary completion	1 January 2018
Estimated completion	1 January 2018
Sites	30 locations across United States, Czechia, France, Germany, Hungary, Mauritius, Poland, Puerto Rico

Drugs / interventions tested

• IPP-201101 — full drug profile →
• Placebo
• Standard of Care

Conditions studied

• Lupus Erythematosus, Systemic — all drugs for Lupus Erythematosus, Systemic →

Sponsor

ImmuPharma — full company profile →

Who can join

Adults 18 to 70, any sex, with Lupus Erythematosus, Systemic. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Assessment of Systemic Lupus Erythematosus Responder Index (SRI) at Week 52
  Time frame: At week 52
  A Systemic lupus erythematosus Responder Index (SRI) response is defined as a reduction from baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of at least 4 points, no worsening in Physician's Global Assessment (PhGA) (with worsening defined as an increase in PhGA of more than 0.30 point from baseline), no new British Isles Lupus Assessment Group A (BILAG A

Sponsor's own description

This current Phase 3 study will evaluate the efficacy and safety of administration of subcutaneous (sc) IPP-201101 in patients with active SLE.

Publications & conference data

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

1. Targeting lysosomes in human disease: from basic research to clinical applications.
   Cao M, Luo X, Wu K, He X. · · 2021 · cited 162× · PMID 34744168 · DOI 10.1038/s41392-021-00778-y
2. Systemic lupus erythematosus: updated insights on the pathogenesis, diagnosis, prevention and therapeutics.
   Dai X, Fan Y, Zhao X. · · 2025 · cited 78× · PMID 40097390 · DOI 10.1038/s41392-025-02168-0
3. Research and therapeutics-traditional and emerging therapies in systemic lupus erythematosus.
   Davis LS, Reimold AM. · · 2017 · cited 37× · PMID 28375452 · DOI 10.1093/rheumatology/kew417
4. Modulation of the immunity and inflammation by autophagy.
   Gan T, Qu S, Zhang H, Zhou XJ. · · 2023 · cited 27× · PMID 37405276 · DOI 10.1002/mco2.311
5. Lupus clinical trial eligibility in a real-world setting: results from the British Isles Lupus Assessment Group-Biologics Register (BILAG-BR).
   Dyball S, Collinson S, Sutton E, McCarthy EM, et al · · 2021 · cited 14× · PMID 34301852 · DOI 10.1136/lupus-2021-000513
6. Immunotherapeutic approaches for systemic lupus erythematosus: early overview and future potential.
   Huang H. · · 2023 · cited 6× · PMID 38282801 · DOI 10.1515/mr-2023-0032
7. Phosphopeptides P140 cause oxidative burst responses of pulmonary macrophages in an imiquimod-induced lupus model.
   Zhong J, Zheng C, Chen Z, Yue H, et al · · 2023 · cited 4× · PMID 37922035 · DOI 10.1186/s43556-023-00149-9
8. Immunotargets and Therapy for Systemic Lupus Erythematosus.
   Mok CC. · · 2025 · cited 3× · PMID 40585390 · DOI 10.2147/itt.s485650