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Lumacaftor/Ivacaftor Combination Therapy in Subjects With CF Who Have an A455E CFTR Mutation
Phase 2 trial testing LUM/IVA in Cystic Fibrosis in 20 participants. Completed in 4 October 2017.
| Lead sponsor | Vertex Pharmaceuticals Incorporated |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 31 January 2017 |
| Primary completion | 6 September 2017 |
| Estimated completion | 4 October 2017 |
| Sites | 2 locations across Netherlands |
Vertex Pharmaceuticals Incorporated — full company profile →
12 and older, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 2.6 | 0.2 – 4.9 |
| LUM/IVA | 2.7 | 0.3 – 5.0 |
Time frame: Up to Week 28. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | LUM/IVA |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Flatulence | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Vulvovaginal mycotic infection | Infections and infestations | — | — |
| Asthma | Respiratory, thoracic and mediastinal disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | — | — |
| Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | — | — |
| Hypertension | Vascular disorders | — | — |
| Exercise tolerance decreased | General disorders | — | — |
| Influenza like illness | General disorders | — | — |
| Libido decreased | Psychiatric disorders | — | — |
| Menopausal symptoms | Reproductive system and breast disorders | — | — |
| Menstruation irregular | Reproductive system and breast disorders | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — |
| Muscle strain | Injury, poisoning and procedural complications | — | — |
| Blood pressure increased | Investigations | — | — |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | — | — |
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | — | — |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | — | — |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | — | — |
| Respiration abnormal | Respiratory, thoracic and mediastinal disorders | — | — |
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | — | — |
| Wheezing | Respiratory, thoracic and mediastinal disorders | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Paraesthesia | Nervous system disorders | — | — |
| Tinnitus | Ear and labyrinth disorders | — | — |
| Abdominal discomfort | Gastrointestinal disorders | — | — |
| Eructation | Gastrointestinal disorders | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
Data from ClinicalTrials.gov NCT03061331 adverse events section.
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study that will evaluate the efficacy of LUM/IVA in subjects with CF 12 years of age and older who have at least one A455E mutation.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03061331.
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