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Lupus Erythematosus, CutaneousPhase 1NCT01702740

A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus

A Phase 1 study testing 1 mg/kg CNTO 136, 4 mg/kg CNTO 136 and 10 mg/kg CNTO 136 in people with Lupus Erythematosus, Cutaneous and Lupus Erythematosus, Systemic, run by Centocor Research & Development, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of this study was to evaluate the safety and pharmacokinetics (PK, the action of a drug in the body over a period of time) of multiple intravenous (IV) administrations of CNTO 136 in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE). Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
1 mg/kg CNTO 136, 4 mg/kg CNTO 136 and 10 mg/kg CNTO 136
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
49 participants
Where
No sites listed yet
Study dates
Mar 2007to Oct 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of cutaneous lupus erythematosus (CLE, including subacute cutaneous lupus erythematosus, discoid lupus erythematosus, or lupus erythematosus tumidus) or systemic lupus erythematosus (SLE)
  • Had a body weight less than or equal to 100 kg
  • Patients in Part A who were taking systemic medications for CLE had to be on a stable dose for 4 weeks before the first study agent infusion
  • Patients in Part B taking systemic medications for SLE had to be on a stable dose for at least 3 months before the first study agent infusion
  • Given informed consent and willing and able to adhere to the study visit schedule and other protocol requirements; agreed to avoid alcohol intake; and took adequate measures to prevent pregnancy

Who cannot join

  • Significant history of or concurrent medical condition (other than lupus)
  • Use of specific previous or concurrent medications or investigational therapies
  • Known or suspected allergy to the study agent or it constituents, having recently donated blood, or having any significant laboratory test values requiring intervention
  • Patients with SLE in Part B could not have active central nervous system lupus

About this study

Official title: A Phase 1, Double-blind, Placebo-controlled, Multiple Intravenous, Ascending-Dose Study of CNTO 136 to Evaluate Safety and Pharmacokinetics in Subjects With Cutaneous Lupus Erythematosus and to Evaluate Safety and Pharmacokinetics in a Cohort of Subjects With Systemic Lupus Erythematosus

The main purpose of this study was to evaluate the safety and pharmacokinetics (PK, the action of a drug in the body over a period of time) of multiple intravenous (IV) administrations of CNTO 136 in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE). The secondary goal of this study was to assess the pharmacodynamics (biochemical and physiological effects of a drug and the mechanisms of action), immune response, and clinical response.

Read the detailed description

In Part A of this study, patients with CLE were randomly assigned (like flipping a coin) to receive multiple IV doses of CNTO 136, a human anti-IL 6 monoclonal antibody (an immune protein that binds to interleukin 6) or placebo (a substance that appears identical to the treatment and has no active ingredients). Patients and study personnel did not know the identity of the administered treatments (double-blind study). Increasing doses were given, based on safety data collected during the initial weeks of treatment. In Part B, which was also double-blind, patients with SLE were randomly assigned to receive multiple IV doses of the highest well-tolerated dose, as determined in Part A, of CNTO 136, or placebo.

Being tested
1 mg/kg CNTO 136, 4 mg/kg CNTO 136, 10 mg/kg CNTO 136, Placebo
Keywords
Cutaneous lupus erythematosus, Systemic lupus erythematosus, Lupus erythematosus, Human anti-IL 6 monoclonal antibody, Sirukumab
Medical subject headings
Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1 mg/kg CNTO 136Drug

    Type=exact number, unit=mg, number=1, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.

  • 4 mg/kg CNTO 136Drug

    Type=exact number, unit=mg, number=4, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.

  • 10 mg/kg CNTO 136Drug

    Type=exact number, unit=mg, number=10, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.

  • PlaceboDrug

    Form=liquid for infusion, route=intravenous use, every 2 weeks for 6 weeks.

Study groups in NCT01702740
Study groupRoleWhat they receive
Part A, 1 mg/kg CNTO 136ExperimentalNot described
Receives: Drug: 1 mg/kg CNTO 136
Part A, 4 mg/kg CNTO 136ExperimentalNot described
Receives: Drug: 4 mg/kg CNTO 136
Part A, 10 mg/kg CNTO 136ExperimentalNot described
Receives: Drug: 10 mg/kg CNTO 136
Part B, 10 mg/kg CNTO 136/placeboExperimentalNot described
Receives: Drug: 10 mg/kg CNTO 136; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events

    Measured: Up to 26 weeks

  2. Pharmacokinetic profile of CNTO 136

    Blood serum concentration over time

    Measured: Up to 22 weeks

  3. Physical examinations

    Assessment of head, eyes, ears, nose and throat, skin and neck, lungs, heart, abdomen, extremities, general neurologic status, and oral examination

    Measured: Up to 26 weeks

  4. Electrocardiograms (ECGs)

    Measured: Up to 26 weeks

  5. Sitting blood pressure

    Measured: Up to 26 weeks

  6. Heart rate

    Measured: Up to 26 weeks

  7. Respiration rate

    Measured: Up to 26 weeks

  8. Oral temperature

    Measured: Up to 26 weeks

  9. Hemoglobin

    Measured: Up to 26 weeks

  10. Hematocrit

    Measured: Up to 26 weeks

  11. Platelets and total white blood cells (WBC)

    Measured: Up to 26 weeks

  12. Albumin and total protein

    Measured: Up to 26 weeks

  13. Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST)

    Measured: Up to 26 weeks

  14. Blood urea nitrogen (BUN), calcium, creatinine, and total bilirubin

    Measured: Up to 26 weeks

  15. Chloride, potassium, and sodium

    Measured: Up to 26 weeks

  16. Bicarbonate

    Measured: Up to 26 weeks

  17. Creatine kinase

    Measured: Up to 26 weeks

  18. Gamma-glutamyl-transferase

    Measured: Up to 26 weeks

  19. Glucose

    Measured: Up to 26 weeks

  20. Lymphocytes and neutrophils

    Measured: Up to 26 weeks

  21. Inorganic phosphate

    Measured: Up to 26 weeks

  22. Fasting Lipid Panel

    Total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), very low-density lipoprotein (VLDL), and triglycerides.

    Measured: Up to 8 weeks

Secondary outcomes (5)

  1. Pharmacodynamics evaluations

    Percentage change from baseline in serum and plasma biomarker data

    Measured: Up to 22 weeks

  2. Immune response

    The formation of antibodies to CNTO 136

    Measured: Up to 22 weeks

  3. Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)

    Measurement of disease activity, scored from 0 (absent) to 70 (severe), and damage, scored from 0 (absent) to 56 (severe)

    Measured: Up to 22 weeks

  4. British Isles Lupus Assessment Group (BILAG) score

    Measures the need for alterations or intensification of therapy. The assessing physician considers each item as to its presence in the past month, and answers 0 = not present, 1 = improving; 2 = same; 3 = worse; or 4 = new.

    Measured: Up to 22 weeks

  5. SELENA-SLEDAI Flare Composite

    Assesses the presence and severity of lupus flare. Scores range from 0 (mild) to 105 (severe).

    Measured: Up to 22 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2012 (estimated)
  2. Study startMar 2007
  3. Primary completionOct 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01702740
Sponsor's protocol ID
CR013000
Other IDs
C0136T03, 2006-002432-25
Status last verified
Oct 2012
First submitted
6 Jul 2012
Last updated
8 Oct 2012
Results posted
No
Data monitoring committee
No

Publications

  • Szepietowski JC, Nilganuwong S, Wozniacka A, Kuhn A, Nyberg F, van Vollenhoven RF, Bengtsson AA, Reich A, de Vries DE, van Hartingsveldt B, Robinson DW Jr, Gordon R, Hsu B. Phase I, randomized, double-blind, placebo-controlled, multiple intravenous, dose-ascending study of sirukumab in cutaneous or systemic lupus erythematosus. Arthritis Rheum. 2013 Oct;65(10):2661-71. doi: 10.1002/art.38091.

    PubMed 23896980

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 1 mg/kg CNTO 136, 4 mg/kg CNTO 136 and 10 mg/kg CNTO 136 in people with Lupus Erythematosus, Cutaneous and Lupus Erythematosus, Systemic, run by Centocor Research & Development, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (time frame: Up to 26 weeks). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01702740, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2012.

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