Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01689025
Other study ID # NN8828-4002
Secondary ID 2011-005699-41U1
Status Terminated
Phase Phase 1
First received September 14, 2012
Last updated April 7, 2014
Start date September 2012
Est. completion date February 2014

Study information

Verified date April 2014
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Hungary: Ministry of Health, Social and Family AffairsPoland: Ministry of Health and Social SecuritySerbia: Medicines and Medical Devices Agency of SerbiaUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate the safety and tolerability of NNC0114-0006 in subjects with systemic lupus erythematosus (SLE) concomitantly treated with stable background therapies.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- Men and women (not pregnant and not nursing)

- Subjects with SLE meeting the American College of Rheumatology (ACR) criteria, with a disease duration of at least 6 months

- Subjects with clinically active SLE defined as a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of at least 6 and positive for antinuclear antibody (ANA) and/or Anti-double-stranded DNA antibody (anti-dsDNA)

- If taken, background medication must be stable

Exclusion Criteria:

- Presence or history of active lupus nephritis (LN) within the last 4 months or active central nervous system (CNS) disease within the last 12 months

- Body mass index (BMI) below 18 kg/m^2 or above 38 kg/m^2

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
NNC0114-0006
Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.
placebo
Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.

Locations

Country Name City State
United States Novo Nordisk Clinical Trial Call Center Houston Texas
United States Novo Nordisk Clinical Trial Call Center La Jolla California

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Hungary,  Poland,  Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events (AEs) From first administration of the trial product and up to week 26 No
Secondary PK endpoint from serum NNC0114-0006: Terminal elimination half-life (t½) After the last dosing (Week 6) No
Secondary PK endpoint from serum NNC0114-0006: Accumulation based on the concentration 2 weeks after the first (week 2) and the last dose (week 8) No
Secondary Change in serum levels of total IL-21 (Interleukin-21) Week 0, week 26 No
Secondary Change in disease activity (SELENA-SLEDAI) Week 0, week 12 No
Secondary Change in corticosteroid usage Week 0, week 12 No
See also
  Status Clinical Trial Phase
Completed NCT03995979 - Inflammation and Protein Restriction N/A
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT03577223 - Egg Effects on the Immunomodulatory Properties of HDL N/A
Completed NCT04383561 - Relationship Between LRG and Periodontal Disease N/A
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT04856748 - Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
Completed NCT05529693 - Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population N/A
Recruiting NCT05670301 - Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases N/A
Recruiting NCT05415397 - Treating Immuno-metabolic Depression With Anti-inflammatory Drugs Phase 3
Recruiting NCT04543877 - WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study Early Phase 1
Recruiting NCT05775731 - Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03429920 - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors N/A
Completed NCT06065241 - Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals. N/A
Completed NCT05864352 - The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
Completed NCT03318731 - Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males N/A
Not yet recruiting NCT06134076 - Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota N/A
Not yet recruiting NCT06159543 - The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes N/A