Rare diseases
Investigational molecules
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N-[2-[(1S)-1-(3-ETHOXY-4-METHOXYPHENYL)-2-(METHANESULFONYL)ETHYL]-3-OXO-2,3-DIHYDRO-1H-ISOINDOL-4-YL]CYCLOPROPANECARBOXAMIDE is an investigational substance with no marketing authorisation in the product records.[1] The substance is also referred to by the development code CC11050 in the trial documentation.[1] It is classified under respiratory tract diseases in the therapeutic area coding of the registry records.[1] The product is supplied by The Aurum Institute for the clinical study.[1] In one product record, the substance is part of a fixed combination.[1]
The clinical trial describes this substance as one of two adjunctive host-directed therapies, specifically an anti-inflammatory agent.[1] Host-directed therapy aims to modify the body's own immune response rather than attacking the tuberculosis bacteria directly. The brief summary states that the trial investigated one anti-inflammatory and one antimicrobial therapy as adjuvants to standard treatment.[1] CC11050 was the anti-inflammatory arm of the study.[1]
The trial condition is recorded as multidrug-resistant pulmonary tuberculosis, also described in the title as rifampin-resistant tuberculosis.[1] The study focuses on patients whose tuberculosis is resistant to rifampicin, one of the main antibiotics used to treat the disease.[1]
The substance is formulated as a hard gelatin capsule for oral use.[1] In the trial, the dose used was 400 mg taken orally.[1] The capsule is swallowed, and the substance is absorbed through the digestive tract.[1]
There is one registered clinical trial investigating this substance: a completed Phase 2 randomised controlled trial with 330 participants.[1] The trial compared two adjunctive host-directed therapies — CC11050 and metformin 1500 mg — each against a control arm.[1] The study had two co-primary objectives that both had to be met for a treatment to be considered successful: forced expiratory volume in one second (FEV1) at month 6, a measure of lung function, and the probability of stable sputum culture conversion by month 6, meaning the tuberculosis bacteria could no longer be grown from patient samples.[1] The primary outcome also included measures of lung function recovery and eradication of Mycobacterium tuberculosis infection, with assessment at month 6, where a nominal month is defined as 4 weeks.[1] The trial status is completed, meaning the study has finished collecting data.[1]
The trial enrolled 330 participants with multidrug-resistant pulmonary tuberculosis.[1] The participants were patients with pulmonary tuberculosis resistant to rifampicin.[1] As the trial is completed, no new participants are being recruited.[1]
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