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lumbar puncture · 1 trial · 6 indications
The primary CSF endpoint of Cohort 2 was the percent change from baseline in absolute lymphocyte counts in CSF after 3 doses of PF-00547659. The hypothesis for the primary endpoint was evaluated using the CSF evaluable population in Cohort 2. CSF samples were obtained via lumbar puncture and analyzed by fluorescence-activated cell sorting (FACS) for total lymphocyte counts. Lumbar punctures were performed by a highly qualified physician using a 20-22 gauge needle, preferably an atraumatic needle.
The primary CSF endpoint of Cohort 2 was the percent change from baseline in absolute lymphocyte counts in CSF after 3 doses of PF-00547659. The hypothesis for the primary endpoint was evaluated using the CSF evaluable population in Cohort 2. CSF samples were obtained via lumbar puncture and analyzed by FACS for total lymphocyte counts. Lumbar punctures were performed by a highly qualified physician using a 20-22 gauge needle, preferably an atraumatic needle.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Interventions prior to treatment. Control arm |
| Cohort 2 | EXPERIMENTAL | Interventions prior to and after 3 monthly injections |
| Name | Type | Description |
|---|---|---|
| lumbar puncture | PROCEDURE | 2 lumbar punctures prior to treatment; study drug 225mg SC once a month X 3 doses. |
Inclusion Criteria: * males and females \>=18 and =\<75 years * For CD subjects: hsCRP \> 5 mg/L and Harvey-Bradshaw Index \> 8 OR when HBI cannot be determined (ie if stoma is present) or hsCRP \< 5mg/L then: active lesions on colonoscopy or flexible sigmoidoscopy or active Crohn's disease on CT o...
| 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 |
Lumbar puncture is a Phase 1 investigational small molecule being studied for Crohn's Disease. It is being evaluated in a clinical trial that also includes patients with ulcerative colitis. The drug is being developed by Takeda Pharmaceutical Company Limited.
Takeda Pharmaceutical Company Limited (ticker: TAK) is developing lumbar puncture. It is an investigational small molecule in Phase 1 clinical development for Crohn's Disease, a gastrointestinal condition.
Lumbar puncture is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied for Crohn's Disease. One Phase 1 trial has been completed.
Lumbar puncture has one completed Phase 1 trial, NCT01387594, which evaluated its effect on cerebrospinal fluid lymphocytes in volunteers with Crohn's Disease or ulcerative colitis who failed or did not tolerate anti-TNFs. The trial enrolled 49 participants across Austria, Belgium, France, Germany, and the Netherlands.
The clinical trial NCT01387594 evaluates PF-00547659, which is the drug being developed by Takeda for Crohn's Disease. The trial title refers to PF-00547659, and this is the investigational agent under study.