Phase 2 Lupus Trial, Completed NCT04433585 Sponsor: Nektar Therapeutics Condition: Lupus
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial tested three different doses of a drug called LY3471851 — a high dose, a middle dose, and a low dose — compared to a placebo (a dummy treatment with no active ingredient) in people with lupus, a condition where the immune system attacks the body's own tissues. A total of 291 people took part across the four groups (73 in the high-dose group, 70 in the middle-dose group, 74 in the low-dose group, and 74 in the placebo group). The trial's main goal was to measure how many participants had a meaningful reduction in their lupus disease activity score — using a standard lupus scoring tool — after 24 weeks. The reported data shows that for the primary (main) outcome — the proportion of people whose lupus disease activity score dropped by at least 4 points at 24 weeks — the figures were: 20% in the high-dose group, 27% in the middle-dose group, 22% in the low-dose group, and 22% in the placebo group. The trial also measured several secondary (additional) outcomes. For a different disease activity measure called BICLA response, the reported figures were 12% (high dose), 26% (mid dose), 18% (low dose), and 18% (placebo). For another measure called SRI-4 response, the figures matched the primary outcome: 20%, 27%, 22%, and 22% respectively. For reaching a "low disease activity state" — a defined level of reduced lupus activity — the reported figures were 12% (high dose), 18% (mid dose), 11% (low dose), and 10% (placebo). The reported data also shows drug levels measured in participants' blood just before each new dose was given: the average level was 214.4 ng/mL (nanograms per millilitre, a measure of concentration) in the high-dose group, 133.3 ng/mL in the middle-dose group, and 55.9 ng/mL in the low-dose group. It is also worth noting that fewer participants in the high-dose group completed the study (44 out of 73) compared to the placebo group (65 out of 74), though the reasons for this were not detailed in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Lupus Trial, Completed

NCT04433585
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with Systemic Lupus Erythematosus (SLE, also known as lupus) for at least 24 weeks before the screening visit.
  • Your diagnosis meets at least 4 out of 11 specific criteria used by doctors to officially classify lupus, based on a widely recognised medical checklist (confirm with trial site).
  • Certain lupus-related proteins or antibodies have been found in your blood during screening tests, such as a positive ANA test, anti-double-stranded DNA, or anti-Smith antibody (confirm with trial site).
  • Your lupus disease activity score (measured by a tool called SLEDAI-2K) is 6 or higher during the screening period (confirm with trial site).
  • Your lupus disease activity score remains at 4 or higher at the point when you would be officially entered into the trial (confirm with trial site).
  • You currently have active joint pain/swelling (arthritis) and/or an active skin rash related to lupus.

Who may not be able to join:

  • You have severe, active lupus that is seriously affecting your kidneys.
  • You have active lupus that is affecting your brain or nervous system.
  • You have a serious or unstable health condition affecting the heart, lungs, liver, digestive system, hormones, blood, or nervous system that the trial doctor believes could put you at risk or affect the trial results.
  • You currently have, or have recently had, a serious infection caused by a virus, bacteria, fungus, or parasite.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Study Director, Nektar Therapeutics

Australian sites

Emeritus Research, Camberwell, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Nektar Therapeutics
Registry
ClinicalTrials.gov
Start date
19 August 2020
Est. completion
10 January 2023

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇨🇦 Canada 🇨🇿 Czechia 🇩🇪 Germany 🇭🇺 Hungary 🇮🇳 India 🇮🇱 Israel 🇯🇵 Japan 🇲🇽 Mexico 🇵🇱 Poland Puerto Rico 🇷🇴 Romania 🇷🇺 Russia 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇺🇦 Ukraine 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants Who Achieved a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov