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- |||||| GSK3858279 / GSK
Trial termination: MARS-17: A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis (OA) Pain (clinicaltrials.gov) - Apr 7, 2025
P2, N=314, Terminated, Sponsor: GlaxoSmithKline
Active, not recruiting --> Terminated; The study met futility criteria at pre-planned interim analysis, showing no clinical efficacy of the investigational drug. Based on the lack of efficacy at the interim data review, the sponsor decided to terminate the study.
- ||| GSK3858279 / GSK
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: NEPTUNE-17: A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - Nov 18, 2024
P2, N=145, Active, not recruiting, Sponsor: GlaxoSmithKline
Based on the lack of efficacy at the interim data review, the sponsor decided to terminate the study. Recruiting --> Active, not recruiting | N=240 --> 145 | Trial completion date: Oct 2025 --> Jan 2025 | Trial primary completion date: Jun 2025 --> Oct 2024
- || GSK3858279 / GSK
Trial completion date, Trial primary completion date: NEPTUNE-17: A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - Sep 23, 2024
P2, N=240, Recruiting, Sponsor: GlaxoSmithKline
Recruiting --> Active, not recruiting | N=240 --> 145 | Trial completion date: Oct 2025 --> Jan 2025 | Trial primary completion date: Jun 2025 --> Oct 2024 Trial completion date: Jun 2025 --> Oct 2025 | Trial primary completion date: Mar 2025 --> Jun 2025
- ||| GSK3858279 / GSK
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: MARS-17: A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis (OA) Pain (clinicaltrials.gov) - Sep 20, 2024
P2, N=263, Active, not recruiting, Sponsor: GlaxoSmithKline
Trial completion date: Jun 2025 --> Oct 2025 | Trial primary completion date: Mar 2025 --> Jun 2025 Recruiting --> Active, not recruiting | N=420 --> 263 | Trial completion date: Oct 2025 --> Nov 2024 | Trial primary completion date: Jul 2025 --> Aug 2024
- || GSK3858279 / GSK
Clinical, Journal: Randomized, placebo-controlled study on the effects of intravenous GSK3858279 (anti-CCL17) on a battery of evoked pain tests in healthy participants. (Pubmed Central) - Sep 9, 2024
P1
All drug-related adverse events were mild in intensity and caused no discontinuations. The absence of an efficacy signal in this acute pain model does not preclude efficacy in chronic pain states.
- |||| GSK3858279 / GSK
Enrollment open, Trial completion date, Trial primary completion date: NEPTUNE-17: A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - Oct 13, 2023
P2, N=240, Recruiting, Sponsor: GlaxoSmithKline
The absence of an efficacy signal in this acute pain model does not preclude efficacy in chronic pain states. Not yet recruiting --> Recruiting | Trial completion date: Jan 2025 --> Jun 2025 | Trial primary completion date: Oct 2024 --> Mar 2025
- |||| GSK3858279 / GSK
Enrollment open, Trial completion date, Trial primary completion date: MARS-17: A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis (OA) Pain (clinicaltrials.gov) - Oct 12, 2023
P2, N=420, Recruiting, Sponsor: GlaxoSmithKline
Not yet recruiting --> Recruiting | Trial completion date: Jan 2025 --> Jun 2025 | Trial primary completion date: Oct 2024 --> Mar 2025 Not yet recruiting --> Recruiting | Trial completion date: Jun 2025 --> Oct 2025 | Trial primary completion date: Feb 2025 --> Jul 2025
- GSK3858279 / GSK
Efficacy, Safety, Pharmacokinetics and Immunogenicity of Repeated Dosing of GSK3858279 in Patients with Knee Osteoarthritis: A Phase I, Randomized, Double-Blind, Placebo-Controlled Study (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_2424;
P1
These compelling data warrant further study of the effectiveness and safety of GSK3858279 in people with OA pain. J.
- ||| GSK3858279 / GSK
Trial initiation date: MARS-17: A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis (OA) Pain (clinicaltrials.gov) - Jul 25, 2023
P2, N=420, Not yet recruiting, Sponsor: GlaxoSmithKline
J. Initiation date: May 2023 --> Sep 2023
- ||| GSK3858279 / GSK
Trial initiation date: NEPTUNE-17: A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - Jul 25, 2023
P2, N=240, Not yet recruiting, Sponsor: GlaxoSmithKline
Initiation date: May 2023 --> Sep 2023 Initiation date: May 2023 --> Sep 2023
- || GSK3858279 / GSK
Trial completion: Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants (clinicaltrials.gov) - Jun 22, 2023
P1, N=32, Completed, Sponsor: GlaxoSmithKline
Initiation date: May 2023 --> Sep 2023 Recruiting --> Completed
- ||||| GSK3858279 / GSK
New P2 trial: MARS-17: A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis (OA) Pain (clinicaltrials.gov) - May 3, 2023
P2, N=420, Not yet recruiting, Sponsor: GlaxoSmithKline
- ||||| GSK3858279 / GSK
New P2 trial: NEPTUNE-17: A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - May 3, 2023
P2, N=240, Not yet recruiting, Sponsor: GlaxoSmithKline
- | GSK3858279 / GSK
Trial completion date, Trial primary completion date: Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants (clinicaltrials.gov) - Dec 28, 2022
P1, N=30, Recruiting, Sponsor: GlaxoSmithKline
Recruiting --> Completed Trial completion date: Jan 2023 --> Jun 2023 | Trial primary completion date: Sep 2022 --> Mar 2023
- ||| GSK3858279 / GSK
Trial completion: A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA) (clinicaltrials.gov) - Oct 20, 2022
P1, N=97, Completed, Sponsor: GlaxoSmithKline
Trial completion date: Jan 2023 --> Jun 2023 | Trial primary completion date: Sep 2022 --> Mar 2023 Active, not recruiting --> Completed
- || GSK3858279 / GSK
Enrollment closed: A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA) (clinicaltrials.gov) - Jul 25, 2022
P1, N=98, Active, not recruiting, Sponsor: GlaxoSmithKline
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || GSK3858279 / GSK
Enrollment open, Trial completion date, Trial primary completion date: Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants (clinicaltrials.gov) - Apr 28, 2022
P1, N=30, Recruiting, Sponsor: GlaxoSmithKline
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting | Trial completion date: Aug 2022 --> Dec 2022 | Trial primary completion date: May 2022 --> Sep 2022
- || GSK3858279 / GSK
New P1 trial: Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants (clinicaltrials.gov) - Dec 29, 2021
P1, N=30, Not yet recruiting, Sponsor: GlaxoSmithKline
- || GSK3858279 / GSK
Trial completion date, Trial primary completion date: A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA) (clinicaltrials.gov) - Nov 10, 2021
P1, N=98, Recruiting, Sponsor: GlaxoSmithKline
Not yet recruiting --> Recruiting | Trial completion date: Aug 2022 --> Dec 2022 | Trial primary completion date: May 2022 --> Sep 2022 Trial completion date: Apr 2022 --> Jul 2022 | Trial primary completion date: Apr 2022 --> Jul 2022
- || GSK3858279 / GSK
Trial completion, Trial completion date, Trial primary completion date: Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Volunteers (clinicaltrials.gov) - Oct 12, 2021
P1, N=25, Completed, Sponsor: GlaxoSmithKline
Trial completion date: Apr 2022 --> Jul 2022 | Trial primary completion date: Apr 2022 --> Jul 2022 Recruiting --> Completed | Trial completion date: Jan 2022 --> Sep 2021 | Trial primary completion date: Jan 2022 --> Sep 2021
- ||| GSK3858279 / GSK
Enrollment open: A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA) (clinicaltrials.gov) - Dec 11, 2020
P1, N=98, Recruiting, Sponsor: GlaxoSmithKline
Recruiting --> Completed | Trial completion date: Jan 2022 --> Sep 2021 | Trial primary completion date: Jan 2022 --> Sep 2021 Suspended --> Recruiting
- || GSK3858279 / GSK
Enrollment open: Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Volunteers (clinicaltrials.gov) - Sep 28, 2020
P1, N=24, Recruiting, Sponsor: GlaxoSmithKline
Suspended --> Recruiting Suspended --> Recruiting
- GSK3858279 / GSK
Trial completion date, Trial primary completion date: Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Volunteers (clinicaltrials.gov) - Jun 25, 2020
P1, N=24, Suspended, Sponsor: GlaxoSmithKline
Suspended --> Recruiting Trial completion date: Apr 2021 --> Aug 2021 | Trial primary completion date: Apr 2021 --> Aug 2021
- ||| GSK3858279 / GSK
Trial suspension: Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Volunteers (clinicaltrials.gov) - May 26, 2020
P1, N=24, Suspended, Sponsor: GlaxoSmithKline
Trial completion date: Apr 2021 --> Aug 2021 | Trial primary completion date: Apr 2021 --> Aug 2021 Recruiting --> Suspended
- | GSK3858279 / GSK
Trial completion date, Trial primary completion date: Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Volunteers (clinicaltrials.gov) - May 6, 2020
P1, N=24, Recruiting, Sponsor: GlaxoSmithKline
Recruiting --> Suspended Trial completion date: Dec 2020 --> Apr 2021 | Trial primary completion date: Dec 2020 --> Apr 2021
- GSK3858279 / GSK
Trial completion date, Trial primary completion date: A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA) (clinicaltrials.gov) - May 5, 2020
P1, N=98, Suspended, Sponsor: GlaxoSmithKline
Trial completion date: Dec 2020 --> Apr 2021 | Trial primary completion date: Dec 2020 --> Apr 2021 Trial completion date: Jul 2021 --> Dec 2021 | Trial primary completion date: Jul 2021 --> Dec 2021
- |||| GSK3858279 / GSK
Trial suspension: A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA) (clinicaltrials.gov) - Apr 24, 2020
P1, N=98, Suspended, Sponsor: GlaxoSmithKline
Trial completion date: Jul 2021 --> Dec 2021 | Trial primary completion date: Jul 2021 --> Dec 2021 Recruiting --> Suspended
- | GSK3858279 / GSK
Trial completion date, Trial primary completion date: Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Volunteers (clinicaltrials.gov) - Apr 5, 2020
P1, N=24, Recruiting, Sponsor: GlaxoSmithKline
Recruiting --> Suspended Trial completion date: Oct 2020 --> Dec 2020 | Trial primary completion date: Oct 2020 --> Dec 2020
- || GSK3858279 / GSK
Trial completion date, Trial primary completion date: A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA) (clinicaltrials.gov) - Mar 11, 2020
P1, N=98, Recruiting, Sponsor: GlaxoSmithKline
Trial completion date: Oct 2020 --> Dec 2020 | Trial primary completion date: Oct 2020 --> Dec 2020 Trial completion date: Feb 2021 --> Jul 2021 | Trial primary completion date: Feb 2021 --> Jul 2021
- || GSK3858279 / GSK
Enrollment open: Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Volunteers (clinicaltrials.gov) - Oct 27, 2019
P1, N=24, Recruiting, Sponsor: GlaxoSmithKline
Trial completion date: Feb 2021 --> Jul 2021 | Trial primary completion date: Feb 2021 --> Jul 2021 Not yet recruiting --> Recruiting
- | GSK3858279 / GSK
New P1 trial: Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Volunteers (clinicaltrials.gov) - Oct 2, 2019
P1, N=24, Not yet recruiting, Sponsor: GlaxoSmithKline
- | GSK3858279 / GSK
Trial completion date, Trial primary completion date: A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA) (clinicaltrials.gov) - Sep 25, 2019
P1, N=98, Recruiting, Sponsor: GlaxoSmithKline
Not yet recruiting --> Recruiting Trial completion date: Nov 2019 --> Feb 2021 | Trial primary completion date: Nov 2019 --> Feb 2021
- ||| GSK3858279 / GSK
Enrollment open: A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA) (clinicaltrials.gov) - Jun 6, 2018
P1, N=98, Recruiting, Sponsor: GlaxoSmithKline
Trial completion date: Nov 2019 --> Feb 2021 | Trial primary completion date: Nov 2019 --> Feb 2021 Not yet recruiting --> Recruiting
- ||| GSK3858279 / GSK
New P1 trial: A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA) (clinicaltrials.gov) - Apr 2, 2018
P1, N=98, Not yet recruiting, Sponsor: GlaxoSmithKline