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SarcoidosisPhase 2NCT00955279

A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis

A Phase 2 study testing Golimumab and Ustekinumab in people with Sarcoidosis, run by Centocor, Inc. at 53 sites in 9 countries.

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

This study tests the safety and effectiveness of ustekinumab or golimumab compared to placebo (placebo looks like the drugs being studied, but has no active ingredients). The purpose of this research study is to determine if ustekinumab or golimumab is safe and to determine its effects (good and bad) on patients with… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Sarcoidosis
What is being tested?
Golimumab and Ustekinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
173 participants
Where
53 sitesin 9 countries
Study dates
Nov 2009to Aug 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have sarcoidosis with onset date of >=2 years prior to screening with at least 1 of the following: a. pulmonary sarcoidosis defined as 1) a diagnosis of sarcoidosis with evidence of lung parenchymal disease (Stage II, III or IV on chest radiograph), and 2) an FVC of >=45% and <=80% of predicted normal value at screening, and 3) an MRC dyspnea score of >2 at screening, and 4) a 6 minute walk distance between 100 to 550 meters at screening, and 5) <=15% absolute change in percent-predicted FVC at baseline relative to screening AND/OR b. skin sarcoidosis defined as 1) active chronic skin lesions for >=3 months either on face or elsewhere on body that have not resolved on current systemic and/or local therapy, and 2) have either: a single lesion of >=2 cm in longest dimension or multiple (3 or more) lesions with at least 1 lesion having a longest dimension of >=1 cm, and 3) have an SPGA score >=2 at screening
  • have been receiving treatment with oral corticosteroids and/or 1 or more immunomodulators for >=3-month period immediately prior to screening
  • on a stable dose of these medications for >=4 weeks before screening

Who cannot join

  • Have a diagnosis of other significant respiratory disorder other than sarcoidosis that would complicate the evaluation of response to treatment
  • Have a smoking history of >=20 pack years
  • Have used an investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer
  • have received previous administration of a treatment with any other therapeutic agent targeted at reducing TNFalpha within 6 months or 5 half-lives of the agent, whichever is longer, prior to screening
  • Patients who have previously received biologic anti-TNFalpha agents outside of the above period are allowed to enter the study
  • Have previously used cyclophosphamide
Show all 10Show fewer
  • Have previously used or received local therapy (including local injections) within 3 months before the screening visit or used or received treatment with prescription topical creams within 1 month before the screening visit for treatment of sarcoidosis skin lesions
  • Have used any therapeutic agent targeted at reducing IL-12 and/or IL-23, including but not limited to, ustekinumab and briakinumab within 6 months or 5 half-lives of the agent, whichever is longer, prior to the screening visit
  • have received natalizumab or agents that deplete or modulate the activity of B cells or T cells within 12 months of screening, or, if after receiving these agents, evidence is available at screening of persistent depletion of the targeted lymphocyte population
  • have used any antibody (monoclonal or polyclonal) or antibody-based agents <= 6 months or within 5 half-lives of the biologic prior to the screening visit, whichever is longer

Trial locations and contacts

53 sites in 9 countries.

53 sites in 9 countries

United States24 sites

  • Study site

    Ann Arbor, Michigan

  • Study site

    Baltimore, Maryland

  • Study site

    Birmingham, Alabama

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Colchester, Vermont

  • Study site

    Columbus, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Detroit, Michigan

  • Study site

    Greenville, North Carolina

  • Study site

    Lebanon, New Hampshire

  • Study site

    Los Angeles, California

  • Study site

    Memphis, Tennessee

  • Study site

    New Haven, Connecticut

  • Study site

    New York, New York

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Spartanburg, South Carolina

  • Study site

    St Louis, Missouri

Other trials in United States

Germany6 sites

  • Study site

    Bad Berka

  • Study site

    Berlin

  • Study site

    Essen

  • Study site

    Freiburg im Breisgau

  • Study site

    Hanover

  • Study site

    München

Other trials in Germany

France5 sites

  • Study site

    Bobigny

  • Study site

    Lille

  • Study site

    Marseille

  • Study site

    Montpellier

  • Study site

    Paris

Other trials in France

United Kingdom5 sites

  • Study site

    Bristol

  • Study site

    London

  • Study site

    Portsmouth

  • Study site

    Sheffield

  • Study site

    Southampton

Other trials in United Kingdom

Denmark4 sites

  • Study site

    Aarhus

  • Study site

    Arhus C

  • Study site

    Hellerup

  • Study site

    København NV

Other trials in Denmark

Belgium3 sites

  • Study site

    Brussels

  • Study site

    Leuven

  • Study site

    Liège

Other trials in Belgium

Netherlands3 sites

  • Study site

    Amsterdam-Zuidoost

  • Study site

    Rotterdam

  • Study site

    Sittard

Other trials in Netherlands

Norway2 sites

  • Study site

    Oslo

  • Study site

    Trondheim

Other trials in Norway

Romania1 site

  • Study site

    Bucharest

Other trials in Romania

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-controlled Study Evaluating the Safety and Efficacy of Treatment With Ustekinumab or Golimumab in Subjects With Chronic Sarcoidosis

This study tests the safety and effectiveness of ustekinumab or golimumab compared to placebo (placebo looks like the drugs being studied, but has no active ingredients). The purpose of this research study is to determine if ustekinumab or golimumab is safe and to determine its effects (good and bad) on patients with chronic sarcoidosis with pulmonary and/or skin involvement. Patients with pulmonary involvement constitute the primary population for analysis, and patients with skin involvement constitute the secondary population; a patient may be in both populations. The study will be conducted at approximately 40 sites globally.

Read the detailed description

Ustekinumab is approved for dosing in patients with psoriasis and golimumab is approved for dosing in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. This study will use either drug in patients with chronic sarcoidosis. Ustekinumab and golimumab are being tested to see if they may be useful in treating chronic sarcoidosis. This study will compare the effects (both good and bad) of ustekinumab and golimumab to those of placebo. The purpose of this study is to evaluate the safety and effectiveness of ustekinumab and golimumab (administered as individual treatments) in patients with chronic sarcoidosis with lung and/or skin involvement who still have symptoms even though receiving current therapy. About 180 patients will take part in the study. While in this study, patients may not take part in any other medical research studies. Ustekinumab and golimumab are not approved by the national health authorities for treatment of chronic sarcoidosis; therefore, they can only be used in a research setting to treat this condition. The screening phase of the study, where the doctor will determine if a patient is eligible for the study, will last 1 to 4 weeks. Patients are put into 1 of 3 groups and each group will get a different treatment. The results of the golimumab group and the ustekinumab group are compared to placebo. Patients will either receive ustekinumab, golimumab or placebo. Placebo looks like ustekinumab and golimumab and is given in the same way, by injection, but contains no active drug. Patients will receive study agent until Week 24 and will continue to be followed through Week 44 for assessment of safety and any other effects after discontinuation of therapy. The patient will continue to take all sarcoidosis medication(s) at current, stable dose for the first part of the study. If the patient remained on a stable steroid dose from Week 0 through Week 16 of the study, the study doctor will begin to taper (lower) the steroid dose. The steroid taper will continue through to the end of the Week 28 visit. The patient will continue to take their other sarcoidosis medication(s) at the same dose for the rest of the study. An independent Data Monitoring Committee will be responsible for reviewing the safety data for the study. Patients will be in the study for about 48 weeks. The end of the study is defined as the last visit of the last patient. A site-specific substudy is being implemented to collect serum and lung samples from patients who are currently enrolled in this study. A separate protocol is being implemented to collect lung fluid and serum samples from normal, healthy subjects to be used as comparators for similar samples obtained in the 1275148SCD2001 substudy. Patients will be randomly assigned to 1 of 3 treatment groups: ustekinumab (180 mg at Week 0, followed by 90 mg at Weeks 8, 16, and 24 with placebo at Weeks 4, 12, and 20), golimumab (200 mg at Week 0, followed by 100 mg at Weeks 4, 8, 12, 16, 20, and 24) or placebo (at Weeks 0, 4, 8, 12, 16, 20, and 24) administered by SC injection.

Conditions
Sarcoidosis
Being tested
Placebo, Golimumab, Ustekinumab
Keywords
Ustekinumab, CNTO 1275, Stelara, Golimumab, CNTO 148, Simponi, Sarcoidosis, Sarcoid, Pulmonary Sarcoidosis, Skin Sarcoidosis
Medical subject headings
Sarcoidosis, Sarcoidosis, Pulmonary

What participants receive

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

  • PlaceboDrug

    Matching Placebo will be administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.

  • GolimumabDrug

    Golimumab will be administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.

  • UstekinumabDrug

    Ustekinumab will be administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.

Study groups in NCT00955279
Study groupRoleWhat they receive
PlaceboPlacebo comparatorMatching Placebo will be administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
Receives: Drug: Placebo
GolimumabExperimentalGolimumab will be administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
Receives: Drug: Golimumab
UstekinumabExperimentalUstekinumab will be administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
Receives: Drug: Ustekinumab

What is being measured

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

  1. Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 16

    Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness . FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Change was calculated as the value at Week 16 minus the baseline value.

    Measured: Baseline (Day 1) and Week 16

Secondary outcomes (4)

  1. Change From Baseline in 6-minute Walk Distance at Week 28

    Change from Baseline in 6-minute walk distance at Week 28 was calculated as 6-minute walk distance at Week 28 minus 6-minute walk distance at Baseline. The 6-minute walk distance was the total distance walked during the 6-minute walk test.

    Measured: Baseline (Day 1) and Week 28

  2. Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 28

    St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Change from Baseline was calculated as the value at Week 28 minus value at Baseline.

    Measured: Baseline (Day 1) and Week 28

  3. Percentage of Responders With a Score of Less Than or Equal to 1 on Skin Physician's Global Assessment (SPGA) Scale

    The SPGA is 7-point scale used to assess the condition of skin in participants. The physician checks the state of the skin and gives them score from 0 (clear) to 5 (severe). Higher scores indicate worsening of skin condition.

    Measured: Week 28

  4. Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 28

    Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Change is calculated as the value at week 28 minus the baseline value.

    Measured: Baseline (Day 1) and Week 28

Timeline

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

  1. First posted10 Aug 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionMay 2012
  4. Study completionAug 2012

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00955279
Sponsor's protocol ID
CR016405
Other IDs
1275148SCD2001, 2009-010714-30, 2009
Status last verified
Jun 2014
First submitted
6 Aug 2009
Last updated
17 Jul 2014
Data monitoring committee
Yes

Publications

  • Judson MA, Mack M, Beaumont JL, Watt R, Barnathan ES, Victorson DE. Validation and important differences for the Sarcoidosis Assessment Tool. A new patient-reported outcome measure. Am J Respir Crit Care Med. 2015 Apr 1;191(7):786-95. doi: 10.1164/rccm.201410-1785OC.

    PubMed 25594886

  • Crommelin HA, Vorselaars AD, van Moorsel CH, Korenromp IH, Deneer VH, Grutters JC. Anti-TNF therapeutics for the treatment of sarcoidosis. Immunotherapy. 2014;6(10):1127-43. doi: 10.2217/imt.14.65.

    PubMed 25428650

  • Judson MA, Baughman RP, Costabel U, Drent M, Gibson KF, Raghu G, Shigemitsu H, Barney JB, Culver DA, Hamzeh NY, Wijsenbeek MS, Albera C, Huizar I, Agarwal P, Brodmerkel C, Watt R, Barnathan ES. Safety and efficacy of ustekinumab or golimumab in patients with chronic sarcoidosis. Eur Respir J. 2014 Nov;44(5):1296-307. doi: 10.1183/09031936.00000914. Epub 2014 Jul 17.

    PubMed 25034562

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Golimumab and Ustekinumab in people with Sarcoidosis, run by Centocor, Inc. at 53 sites in 9 countries.

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 3 inclusion and 10 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 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Germany, France, United Kingdom, Denmark and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 16 (time frame: Baseline (Day 1) and Week 16). 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 NCT00955279, which also lists 3 linked publications.

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 17 Jul 2014.

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