Recruiting 3rd quarter 2003 – 3rd quarter 2004

Bosentan Use in Interstitial Lung Disease
BUILD 2

A double-blind, randomized, placebo-controlled, multicenter study to assess the efficacy, safety and tolerability of bosentan in patients with interstitial lung disease associated with systemic sclerosis.

Sponsor: Actelion Pharmaceuticals Ltd

Co-ordinating Centre: Not applicable (J. Korn chairman of the Steering Committee)

Centres involved (site participation depends on IRB/ regulatory approval):

USA

• University of Washington, Seattle Dr. Raghu +1 206 543 4967
  graghu@u.washington.edu
• RW Johnson Med School, New Brunswick Dr. Seibold +1 732 235 7578
  mcclosda@umdnj.edu
• St Peters Hospital, Albany Dr. Shapiro +1 518 489 4471
  Lshapiro@joint-docs.com
• Virginia Mason Medical Center, Seattle Dr. Molitor +1 206 223 6836
  rhejam@vmmc.org
• Medical Univ South Carolina, Charleston Dr. Silver +1 843 792 3484
  silverr@musc.edu
• Georgetown University, Washington Dr. Steen +1 202 444 8233
  steenv@georgetown.edu
• Chicago College of Medicine, Chicago Dr. Varga +1 312 413 9311
  jvarga@uic.edu
• Cleveland Clinic, Cleveland, OH Dr Soumya Chatterjee (216) 444-9945 chattes@ccf.org
• Denver Health Medical Center, Denver Dr. Collier +1 303 436 6902
  dcollier@DHHA.org
• UCLA Med School, LA Dr. Furst +1 310 794 9504
  DEFurst@mednet.ucla.edu
• Jefferson Medical College, Philadelphia Dr. Jimenez +1.215 503-5042
  Kate.Salmon@mail.tju.edu
• Boston Univ School of Medicine, Boston Dr. Korn +1.617.638.4486
  jkorn@bu.edu
• Univ Texas Houston Medical School, Houston Dr. Mayes +1 713 500 7118
  samantha.r.jordan@uth.tmc.edu
• University of Pittsburgh, Pittsburgh Dr. Medsger +1 412 383 8765
  medsger@msx.dept-med.pitt.edu
• Jackson Memorial Hospital, Miami, FL Dr Marilyn Glassberg (305) 243-6388 mglassbe@med.miami.edu

Europe / Israel

• Charité Universitätsklinikum,Berlin DE Dr. Riemekasten +49 304 5051 3055
  gabriela.riemekasten@charite.de
• Hôpital Saint Antoine, Paris FR Dr. Cabane +33 1 49 28 23 87
  jean.cabane@sat.ap-hop-paris.fr
• Centre Hospitalier Universitaire,Grenoble FR Dr. Carpentier +33 4 76 76 89 60
  patrick.carpentier@ujf-grenoble.fr
• Hôpital Cochin, Paris FR Dr. Guillevin +33 1 58 41 13 10
  loic.guillevin@cch.ap-hop-paris.fr
• Instituto di Clinica, Firenze IT Dr. Matucci Cerinic +39 05 54 27 92 71
  cerinic@unifi.it
• Ospedale Maggiore, Milano IT Dr. Scorza +39 02 55 03 52 89
  raffaella.scorza@unimi.it
• Policlinico Universitario, Padova IT Dr. Todesco +39 049 82 12 190
  silvano.todesco@unipd.it
• Sint Maartenskliniek, Nijmegen NL Dr. van den Hoogen +31 24 36 59 275
  f.vandenhoogen@maartenskliniek.nl
• Lund University Hospital, Lund SW Dr. Akesson +46 46 17 21 53
  anita.akesson@reum.lu.se
• University Hospital,Zürich CH Dr. Brühlmann +41 1 255 29 96
  pius.bruehlmann@usz.ch
• Royal Free Hospital, London UK Dr. Black +44 207 794 04 32
  c.black@rfc.ucl.ac.uk
• Leeds General Infirmary, Leeds UK Dr. Emery +44 113 392 50 68
  medna@leeds.ac.uk
• Rabin Medical Center, Petach Tikva IL Dr. Kramer +972 3 9377221
  kramerm@mail.netvision.net.il
• CHRU Claude Huriez, Lille, France Dr Eric Hachulla +33 3 20 44 42 96 ehachulla@chru.lille.fr

Design: Multicenter, randomized, double-blind, placebo-controlled, phase II/III study.
Patient Selection Criteria:

Inclusion Criteria (main):

• Systemic Sclerosis diffuse or limited.
• Significant Interstitial Lung Disease on HRCT scan.
• DLco < 80% predicted.
• Dyspnea on exertion.
• Walk not limited by musculoskeletal reasons.

Exclusion Criteria (main):

• ILD due to conditions other than SSc.
• End stage restrictive or obstructive lung disease.
• Severe cardiac or renal diseases.
• Significant pulmonary arterial hypertension.
• Smoker (> 5cig./day).
• Treatments with immunosuppressive, antifibrotic drugs, high dose corticosteroids (within 4 weeks of randomization)

Outcome Measures:
Primary - Change from baseline in 6-minute walk distance.
Secondary - Time to death or to worsening of PFTs.

Time Line:

• Recruitment period: 3rd quarter 2003 – 3rd quarter 2004
• Completion: 3rd quarter  2005
• Date of Expected Analysis: 4th quarter 2005

If you have a patient that you think might be suitable, or if you would like more information about the study please visit our web site on www.sctc-online.org or the web site dedicated to the study: www.build-2.com

To date there is no evidence that bosentan is safe and effective in Interstitial Lung Disease associated with SSc.

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