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Also known as GLPG3970 oral solution, GLPG3970 film-coated tablet, GLPG3970 film-coated, [14C]GLPG3970 solution for infusion, GLPG3970 for infusion, [14]GLPG3970 oral solution
GLPG3970 · 3 trials · 4 indications
The DAS28 (CRP) is a derived measurement with differential weighting given to each component such as TJC28, SJC28, patient's global assessment of disease activity, and serum CRP level. * TJC28 ranges from 0-28 * SJC28 ranges from 0-28 * High sensitivity C-reactive protein (hsCRP) (in mg/L) * Patient's disease activity VAS (in mm) (ranges from 0 = best to 100 = worst) The DAS28 (CRP) score was calculated using the below formula: DAS28 (CRP) = 0.56 x square root of TJC28 + 0.28 x square root of SJC28 + 0.36 x Ln\[1+CRP(in mg/L)\] + 0.014 x patient's disease activity VAS (in mm) + 0.96. A lower score is considered as better disease activity.
The MCS is the primary tool for assessing ulcerative colitis activity. Total MCS is the sum of 4 subscores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician's global assessment); each rated on a scale from 0 (normal) to 3 (severe). The total MCS value ranges from 0 to 12, with higher scores indicating more severe disease. Missing data were imputed using Rubin's multiple imputation.
To evaluate the safety and tolerability of GLPG3970 compared to placebo in adult healthy male subjects as single and multiple ascending oral doses, and in subjects with moderate to severe psoriasis when administered daily for 6 weeks
| Arm | Type | Description |
|---|---|---|
| GLPG3970 | EXPERIMENTAL | Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks. |
| GLPG3970 SAD | EXPERIMENTAL | Single doses of GLPG3970 at up to 6 dose levels in ascending order |
| Placebo SAD | PLACEBO_COMPARATOR | Single doses of placebo |
| GLPG3970 MAD | EXPERIMENTAL | Multiple doses of GLPG3970 at up to 4 dose levels in ascending order, daily for 14 days |
| Placebo MAD | PLACEBO_COMPARATOR | Multiple doses of placebo |
| GLPG3970 FE-rBA | EXPERIMENTAL | Single dose of GLPG3970 in fed and fasted state |
| GLPG3970 FE | EXPERIMENTAL | Single dose of GLPG3970 in fed and fasted state |
| GLPG3970 in psoriasis subjects | EXPERIMENTAL | - |
| Placebo in psoriasis subjects | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GLPG3970 | DRUG | GLPG3970 powder and solvent for oral solution to be reconstituted prior to use. |
| Placebo | DRUG | Placebo powder and solvent for oral solution to be reconstituted prior to use. |
| GLPG3970 oral solution | DRUG | GLPG3970 for oral administration |
| Placebo oral solution | DRUG | Placebo for oral administration |
| GLPG3970 capsule | DRUG | GLPG3970 for oral administration |
Key Inclusion Criteria: 1. A body mass index (BMI) between 18-32 kg/m\^2, inclusive. 2. Diagnosis of RA ≥6 months prior to screening AND meeting the 2010 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) criteria of RA AND ACR functional class I-III. 3. Have ≥6 swol...
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GLPG3970 is an investigational oral small molecule developed by Lakefront Biotherapeutics (ticker LKFT). It is being studied for inflammatory conditions including psoriasis, rheumatoid arthritis, and ulcerative colitis. It is a kinase inhibitor that targets SIK2 and SIK3, and it has been tested in Phase 1 and Phase 2 clinical trials.
GLPG3970 targets SIK2 and SIK3, two kinases in the salt-inducible kinase family. By inhibiting these kinase enzymes, the drug is designed to modulate inflammatory signaling pathways relevant to autoimmune and inflammatory diseases such as psoriasis, rheumatoid arthritis, and ulcerative colitis.
GLPG3970 is developed by Lakefront Biotherapeutics, which trades under the ticker LKFT. The company has sponsored clinical studies of the drug in healthy volunteers and in patients with ulcerative colitis and rheumatoid arthritis across sites in Europe and nearby countries.
GLPG3970 is in Phase 1 development according to its overall program status, and it is investigational, meaning it has not been approved by the FDA. Phase 2 studies of GLPG3970 in ulcerative colitis and rheumatoid arthritis have been completed, and no trials are currently active.
GLPG3970 has been studied in completed trials including NCT04106297, a Phase 1 study of single and multiple oral doses in healthy volunteers and psoriasis patients, NCT04577794, a Phase 2 study in ulcerative colitis, and NCT04577781, a Phase 2 study in rheumatoid arthritis. All three trials are completed.
Yes. GLPG3970 oral solution, GLPG3970 film-coated tablet, GLPG3970 film-coated, [14C]GLPG3970 solution for infusion, GLPG3970 for infusion, and [14]GLPG3970 oral solution are all names referring to the same investigational drug, GLPG3970, developed by Lakefront Biotherapeutics.