Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01716312 · ClinicalTrials.gov registry record · Phase 1
Omalizumab for Lupus
A Phase 1 study of Sjogren's Syndrome and Systemic Lupus Erthematosus, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT01716312: Completed Phase 1 study of Sjogren's Syndrome and Systemic Lupus Erthematosus, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
NCT01716312 is a Phase 1 study of Sjogren's Syndrome and Systemic Lupus Erthematosus that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 17 participants, below the 287-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01716312, a Phase 1 study of Sjogren's Syndrome and Systemic Lupus Erthematosus, has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
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 t
Primary Outcome
The primary outcome is to evaluate the safety and tolerance of omalizumab in patients with SLE. This analysis will include rates ofadverse events (serious adverse events, Grade 3 and 4 toxicities not fulfilling the criteria for SAE, and nonserious adverse events).
Conditions Studied
Interventions
- DRUG Omalizumab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2014-01-08 |
| Est. Completion | 2017-08-24 |
| Phase | Phase 1 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
What the finished NCT01716312 record still lists
NCT01716312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 287-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Sjogren's Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Omalizumab is the first listed.
NCT01716312 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01716312 about?
NCT01716312 is a clinical study titled "Omalizumab for Lupus". 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-threateni...
What is the current status of trial NCT01716312?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2014-01-08. Estimated completion is 2017-08-24.
What conditions does trial NCT01716312 study?
This clinical trial studies the following conditions: Sjogren's Syndrome, Systemic Lupus Erthematosus.
What interventions are being tested in trial NCT01716312?
The interventions under investigation include: Omalizumab (DRUG).
Who is sponsoring clinical trial NCT01716312?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01716312 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sjogren's Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01716312's enrollment target sits among peer trials
17 20th of 20 higher than 1 of 20 other Sjogren's Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sjogren's Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease
RECRUITING · Phase 1
-
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome
ACTIVE NOT RECRUITING · Phase 1
-
Anti-CD20 Antibody Therapy for Sjogren's Syndrome
COMPLETED · Phase 1
-
An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness
COMPLETED · Phase 1
-
Rheumatology Diet Study
RECRUITING
-
Creating Health Course Study for People With Rheumatological Conditions
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02090140 · 17 participants · NA
Microfracture Versus Adipose Derived Stem Cells for the Treatment of Articular Cartilage Defects
- NCT03317860 · 17 participants · NA
Improving Measurement and Treatment of Post-stroke Neglect
- NCT04356469 · 17 participants · Phase 2
TCR Alpha Beta T-cell Depleted Haploidentical HCT in the Treatment of Non-Malignant Hematological Disorders in Children
- NCT04414046 · 17 participants · Phase 2
TCR Alpha Beta T-cell Depleted Haploidentical HCT in the Treatment of Primary Immunodeficiency and Inherited Metabolic Disorders in Children
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI