Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK1605786A · 1 trial · 1 indication
CDAI is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. The score was algorithmically derived from the sum of participant reported Crohn's disease symptoms recorded over 7 days and investigator recorded assessments of the participant's condition, laboratory parameters and use of anti-diarrhoeal medication. CDAI score was calculated based on the data collected in the diary card. The total CDAI score ranged from 0 to approximately 600, where higher scores indicate more severe disease. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of participants with CDAI response at Week 12 was presented.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | orally administered |
| GSK1605786A 500mg once daily | EXPERIMENTAL | orally administered |
| GSK1605786A 500mg twice daily | EXPERIMENTAL | orally administered |
| Name | Type | Description |
|---|---|---|
| GSK1605786A | DRUG | 500 mg twice daily, administered orally for 12 weeks |
| Placebo | DRUG | Placebo capsules, administered orally for 12 weeks |
Inclusion Criteria: * Male or female subjects aged 18 years or older * Written informed consent * Diagnosis of Crohn's disease for greater than 4 months duration with small bowel and/or colonic involvement * Confirmation of Crohn's disease established by visualisation of the gastrointestinal tract ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 6 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Risankizumab, Risankizumab On-Body Injector |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 16 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
GSK1605786A is an investigational small molecule being studied for the treatment of moderately-to-severely active Crohn's Disease. It is intended for adult patients, as the clinical trial enrolled participants aged 18 years and older. The drug is not approved and remains in clinical development.
GSK1605786A is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company sponsored the Phase 3 clinical trial of this investigational drug for Crohn's Disease.
GSK1605786A is in Phase 3 clinical development for Crohn's Disease. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, but the drug is not yet available as a marketed therapy.
GSK1605786A was studied in a Phase 3 clinical trial with the identifier NCT01277666. This was a randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of the drug in subjects with moderately-to-severely active Crohn's Disease. The trial enrolled 608 participants and has been completed.
GSK1605786A is the investigational code name for this drug candidate. No alternative brand names or other designations have been disclosed in the available information. The drug is identified solely by its code name in clinical trial records.