NCT01716312

Omalizumab for Lupus

Completed Phase 1 Last updated 20 April 2022

What this trial tests

Phase 1 trial testing Omalizumab in Systemic Lupus Erthematosus in 17 participants. Completed in 24 August 2017.

Timeline

8 January 2014

Primary endpoint
24 August 2017

24 August 2017

Quick facts

Lead sponsor	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	17
Start date	8 January 2014
Primary completion	24 August 2017
Estimated completion	24 August 2017
Sites	1 location across United States

Drugs / interventions tested

• Omalizumab (omalizumab) — full drug profile →

Conditions studied

• Systemic Lupus Erthematosus — all drugs for Systemic Lupus Erthematosus →
• Sjogren's Syndrome — all drugs for Sjogren's Syndrome →

Sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Who can join

Adults 18 to 100, any sex, with Systemic Lupus Erthematosus or Sjogren's Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

* Systemic Lupus Erythematosus (SLE or lupus) is an autoimmune disease, which means the body's immune system mistakenly attacks healthy tissue resulting in inflammation and tissue damage. SLE can involve almost any organ and its symptoms can range in severity from mild to life-threatening; symptoms also vary from person to person. Current treatments for lupus are not effective for some people. Medications used to treat lupus can have serious side effects.
* Omalizumab is a drug that has been used to treat severe allergic asthma. It helps to prevent allergic reactions by reducing some antibodies in the blood. These antibodies are also present in some people with Lupus. Researchers want to see if omalizumab is a safe and effective treatment for people with Lupus.

Objectives:

\- To test the safety of omalizumab for people with lupus.

Eligibility:

\- Individuals at least 18 years of age who have moderately active Lupus even with standard treatments.

Design:

* Subject screening will take place at the NIH Clinical Center and will include a medical history, a physical exam, blood and urine laboratory tests, an assessment of Lupus disease activity. Some participants may require some additional testing. All eligible persons who are interested in enrolling will be asked to come back to the NIH within 2 weeks to begin the study.
* The study will be conducted in three phases, with a total of 15 study visits over 38 weeks. Two visits will be overnight hospital stays. The rest will be outpatient visits. During each visit the participants will be monitored by doing a physical exam, assessment of their lupus disease activity, review of any treatment related side effects, blood and urine testing.
* For the first phase, participants will have infusions (under their skin) of either omalizumab or a placebo. They will have an overnight hospital stay for the first infusion and then an outpatient safety monitor visit 2 weeks after. If subjects safety measures are good they will return in 2 weeks and receive the second dose. They will then get three more doses every 4 weeks which will be given during outpatient visits to the NIH.
* In the second phase, which begins at the 16th week of the study, all participants will receive omalizumab. This means that subjects who had been getting omalizumab will continue receiving it and subjects who had been receiving the placebo will now begin getting omalizumab. They will have an overnight hospital stay for this infusion and will return in 2 weeks for a safety monitor visit. If subjects safety measures are good they will return in 2 weeks and receive the next dose. They will then get three more doses every 4 weeks which will be given during outpatient visits to the NIH.
* The third phase will be a final series of visits which will take place at week 32 and week 36. During these visits subjects will have a physical exam which includes disease activity assessment, blood and urine tests. No medication will be given during these visits.
* All subjects will be given information, instruction and medications for possible allergic reactions to omalizumab.
* Throughout the study other tests and procedures will be performed as needed.

Publications & conference data

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

1. Safety and Tolerability of Omalizumab: A Randomized Clinical Trial of Humanized Anti-IgE Monoclonal Antibody in Systemic Lupus Erythematosus.
   Hasni S, Gupta S, Davis M, Poncio E, et al · · 2019 · cited 49× · PMID 30597768 · DOI 10.1002/art.40828
2. A cytotoxic anti-IL-3Rα antibody targets key cells and cytokines implicated in systemic lupus erythematosus.
   Oon S, Huynh H, Tai TY, Ng M, et al · · 2016 · cited 27× · PMID 27699260 · DOI 10.1172/jci.insight.86131
3. Interventions for cutaneous disease in systemic lupus erythematosus.
   Hannon CW, McCourt C, Lima HC, Chen S, et al · · 2021 · cited 26× · PMID 33687069 · DOI 10.1002/14651858.cd007478.pub2
4. Basophils beyond allergic and parasitic diseases.
   Poto R, Loffredo S, Marone G, Di Salvatore A, et al · · 2023 · cited 23× · PMID 37205111 · DOI 10.3389/fimmu.2023.1190034
5. IgE-Mediated Immune Response and Antibody-Mediated Rejection.
   Rascio F, Pontrelli P, Netti GS, Manno E, et al · · 2020 · cited 16× · PMID 32907809 · DOI 10.2215/cjn.02870320
6. A new look at IgE beyond allergies.
   Luker AJ, Lownik JC, Conrad DH, Martin RK. · · 2019 · cited 8× · PMID 31168357 · DOI 10.12688/f1000research.18186.1
7. Allergic reactions in systemic lupus erythematosus: From pathogenic pathways to clinical practice.
   Le HBC, Hirankarn N, Leelahavanichkul A. · · 2026 · PMID 41960556 · DOI 10.5415/apallergy.0000000000000226