Content about Clinical trial

LONDON — GlaxoSmithKline has started a late-stage clinical trial of a drug in patients with an inflammatory disease that affects the blood vessels.

The drug maker announced the start of a phase-3 trial of Benlysta (belimumab) in patients with vasculitis, a condition in which the body's immune system attacks blood vessels, leading to inflammation, disruption of blood flow and possible damage to the organs. The drug is being tested in patients with a common form of the disease known as anti-neutrophil cytoplasmic antibodies-positive vasculitis.

WESTON, Mass. — An experimental drug for Lou Gehrig's disease made by Biogen Idec has failed in a late-stage clinical trial, the drug maker said Thursday.

Biogen announced results of its phase-3 trial of dexpramipexole in patients with the disease, known technically as amyotrophic lateral sclerosis, or ALS. The drug failed to improve functioning and survival in patients and failed to show efficacy in key secondary endpoints as well, the company said.

ABBOTT PARK, Ill. — Patients with a form of arthritis that affects young adults taking a drug made by Abbott experienced improvements in their condition after a year of treatment, according to late-stage clinical trial results.

Abbott announced Monday the first long-term patient-reported health outcomes data for the phase-3 "ABILITY-1" trial of Humira (adalimumab) in patients with nonradiographic axial spondyloarthritis, or nr-axSpA. Results of the trial were presented at the American College of Rheumatology's annual scientific meeting in Washington.

LAS VEGAS — More patients with an inflammatory disease of the bowels responded to a drug used for autoimmune disorders than those taking a placebo, according to results of a late-stage clinical trial announced Monday.

Johnson & Johnson said phase-3 trial findings showed that "significantly" more patients with severely active ulcerative colitis responded to Simponi (golimumab), maintaining their responsiveness to the drug through the 54th week. The drug is already approved by the Food and Drug Administration for treating conditions like rheumatoid arthritis.

SILVER SPRING, M.D. — The Food and Drug Administration may be willing to speed up trials for drugs that could be a big benefit to society despite their risks.

According to several published reports, FDA commissioner Margaret Hamburg recently told a group of scientific advisers that the agency is considering allowing makers of drugs having a societal benefit to conduct faster clinical trials with a smaller group of patients than is now required.

BOTHELL, Wash. — Drug maker OncoGenex Pharmaceuticals has started its third late-stage clinical trial of a drug for treating a type of lung cancer.

OncoGenex announced Friday the initiation of the phase-3 "ENSPIRIT" trial of custirsen in patients with nonsmall cell lung cancer that has spread to other parts of the body, also known as metastasis, and whose disease has progressed after initial treatment with chemotherapy has failed.

WHITEHOUSE STATION, N.J. — A study of an experimental drug for insomnia indicated that patients who stop taking it continue having sleeping problems, according to results of a clinical trial announced Monday.

Merck released data from a phase-3 trial of suvorexant in which patients who had been taking the drug daily for a year were switched to placebo for a two-month "discontinuation phase." Patients who were switched from the drug to placebo showed sleeping difficulties similar to those who had consistently taken placebo.

EAST HANOVER, N.J. — An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

A phase-3 study published in the American Journal of Transplantation found that patients taking RAD001 (everolimus) with a reduced dose of Astellas' Prograf (tacrolimus) experienced equal efficacy and superior kidney function to patients taking Prograf alone.

INDIANAPOLIS — A biotech drug made by Eli Lilly for osteoporosis appeared no more or less effective than a pharmaceutical drug available as a generic in treating women with related bone fractures, but was more effective in some other measures, according to results of a late-stage clinical trial released Tuesday.

DEERFIELD, Ill. — Drug maker Takeda Pharmaceutical has resubmitted regulatory approval applications for two drugs designed to treat diabetes, the company said.

Takeda announced the resubmission to the Food and Drug Administration of applications for alogliptin and a drug that combines alogliptin with pioglitazone, the active ingredient in the Takeda drug Actos.

INDIANAPOLIS — A clinical trial of a drug for schizophrenia did not yield the desired results, the drug's developer said.

Eli Lilly announced results of the H8Y-MC-HBBM study of pomaglumetad methionil, for patients with acute exacerbation of schizophrenia. The company said results did not show the drug produced a significantly different effect from the placebo.