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TESRA: (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist)

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Roche

Status and phase

Completed
Phase 2

Conditions

Emphysema

Treatments

Drug: RAR Gamma
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00413205
NB19751

Details and patient eligibility

About

This 2 arm study will investigate the efficacy, safety and tolerability of RAR Gamma versus placebo in ex-smokers with moderate or severe emphysema treated with optimal COPD therapy. Following optimization of COPD therapy (up to 6 weeks) patients will be randomized to receive either RAR Gamma (5mg) or placebo once daily using a 2:1 ratio (active:placebo), in addition to their standard therapy. Following the double-blind treatment period, patients will enter a 4-week follow-up period. The anticipated time on study period is 1-2 years, and the target sample size is 100-500 individuals.

Enrollment

491 patients

Sex

All

Ages

44+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients of >44 years of age, with >10 pack-year smoking history;
  • women not of child-bearing potential;
  • ex-smokers (must have stopped smoking for >=12 months) with clinical diagnosis of emphysema;
  • willing to be switched to optimal COPD therapy.

Exclusion criteria

  • off oral steroids >28 days prior to enrollment;
  • >2 exacerbations of pulmonary symptoms requiring outpatient treatment, or >1 exacerbation requiring hospitalization, within 12 months prior to screening;
  • exposure to synthetic oral retinoids in past 12 months;
  • history of allergy or sensitivity to retinoids.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

491 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
po daily
Treatment:
Drug: Placebo
RAR Gamma
Experimental group
Description:
5mg po daily
Treatment:
Drug: RAR Gamma

Trial contacts and locations

64

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Data sourced from clinicaltrials.gov

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