Participants initially received secukinumab 75mg subcutaneously once every four weeks in the extension study. If the signs and symptoms of the participants were not adequately controlled with the 75mg dose, as determined by the investigator, the dose could be escalated to 150mg subcutaneously. For patients weighing 50kg and over, the dose could further be escalated to 300mg subcutaneously every four weeks. The dose escalation from secukinumab 75mg subcutaneously to 300mg subcutaneously was to be implemented in two steps, with the first step being an increase to 150mg subcutaneously, followed by another escalation to 300mg subcutaneously, based on the judgement of the investigator.

Secukinumab solution for subcutaneous injections was provided in PFS. Initially, participants continued to receive secukinumab at either 75 mg (in 0.5mL) or 150 mg (in 1mL) every 4 weeks, consistent with their dosage at the Week 100 visit of the core study. The dose could be escalated from 75 mg to 150 mg for patients whose signs and symptoms were not fully controlled, as judged by the investigator, with the current 75 mg dose. Furthermore, the dose could also be escalated to 300 mg every 4 weeks for patients weighing 50kg and over who were currently on the 150 mg dose and whose signs and symptoms were not well-controlled, as judged by the investigator. The dose escalation from secukinumab 75 mg to 300 mg was to be implemented in two steps (first 150 mg and then 300 mg based on the investigator's judgment). At each study treatment time point, one or two subcutaneous injections in the form of PFS were administered.

Secukinumab

Participants initially received secukinumab 150mg subcutaneously once every four weeks in the extension study. If the signs and symptoms of the participants were not adequately controlled with the 150mg dose, as determined by the investigator, the dose could be escalated to 300mg subcutaneously.

Pharmaceutically manufactured. Cannabidiol is formulated as a clear gel for transdermal delivery.

Pharmaceutically manufactured cannabidiol formulated as a clear gel that can be applied to the skin (transdermal delivery)

ZYN002 - transdermal gel

Placebo is formulated as a clear gel for transdermal delivery.

Placebo formulated as a clear gel that can be applied to the skin (transdermal delivery)

Other Names:

Placebo Comparator Matching Placebo

Placebo

Participants received ELX 200 milligram (mg) once daily (qd)/TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) in the treatment period approximately 13 weeks.

Fixed dose combination (FDC) tablet for oral administration.

ELX/TEZ/IVA

6 subjects each will receive RVP-001 at a dose of 2 mg Mn/kg

RVP-001

6 subjects each will receive RVP-001 at a dose of 7 mg Mn/kg

6 subjects each will receive RVP-001 at a dose of 12 mg Mn/kg

늦은 단계 망막색소변성증 환자에게 6주 간격으로 KIO-301을 눈에 주사해 안전성과 효과를 살피는 시험입니다.

50 μg KIO-301 or placebo administered by IVT injection bilaterally (OU) once every 6 weeks for 3 administrations per participant.

A control 50 μl injection of clear sterile saline or balanced salt solution (BSS) liquid.

Placebo (Sterile Saline or Balanced Salt Solution)

KIO-301 drug product is an ophthalmic formulation of the drug substance KIO-300-Cl in sulfobutylether-β-cyclodextrin, sucrose, phosphate buffer salts and water suitable for IVT injection. The drug substance KIO-300-Cl is a quaternary ammonium chloride salt of the active compound KIO-300.

50 μg KIO-301

100 μg KIO-301 or placebo administered by IVT injection OU once every 6 weeks for 3 administrations per participant.

100 μg KIO-301

참가자당 3회에 걸쳐 6주 간격으로 50μg의 KIO-301 또는 위약을 양측(OU)에 정맥 내 주사(IVT)로 투여했습니다.

위약(멸균 식염수 또는 균형 염 용액)

참가자당 6주 간격으로 3회에 걸쳐 100μg의 KIO-301 또는 위약을 양안 정맥 내 주사(IVT)로 투여하였다.

John Grigg

Brett Caldwell

Anthony Kwan

Melanie Willoughby

Robert Casson

Lisa Lombardi

Doron Hickey

Tammy Corica

Fred Chen

말기 색소성 망막염 환자를 대상으로 한 KIO-301의 유리체강내 주사 2상 임상 연구

Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening.

Fixed-dose combination granules for oral administration.

Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening with the dose(s) to be based on the outcome of Part A.

Patients receive botensilimab IV, balstilimab IV, and regorafenib PO on study. Patients also undergo CT and collection of blood throughout the study.

Balstilimab

Biospecimen Collection

Botensilimab

Computed Tomography

Regorafenib

7.5mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water

CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a concentration of up to 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose HDPE containers. The study doses vary by the concentration of gold nanocrystals per milliliter in a volume of 60 mL.

gold nanocrystals

15mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water

30mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water

60mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water

XXB750 drug

Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks

LTP001, 6 mg, was administered orally once daily in the morning

LTP001

Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks

Placebo to LTP001 was administered once daily in the morning

Obese pts with hypertension, starting treatment with eplerenone 25mg twice daily (BD). ABPM wil be scheduled at wks 8, 16 and 24.

At wk 8 if mean ABPM \< 130/80mm Hg will continue to monotherapy with eplerenone. If not controlled (mean ABPM \> 130/80mm Hg) at wk8, amlodipine 5mg OD will be added.

At wk 16 if mean ABPM \< 130/80mm Hg will continue to monotherapy with eplerenone, or dual therapy with eplerenone and amlodipine. If not controlled (mean ABPM \> 130/80mm Hg) at wk16, indapamide 1,5mg OD will be added. All patients will be followed up for 24 weeks.

At randomization, pts meeting inclusion/exclusion criteria will be randomized (1:1) to either eplerenone (E) 25mg bd or valsartan (V) 160mg od for 8 wks. At 8, 16 and 24 wks, pts at both arms will be evaluated with ABPM primary, as well as home and office BP measurements. At wk 8, pts with controlled hypertension (mean ABPM \<130/80mmHg), will continue in monotherapy with eplerenone or valsartan and pts with uncontrolled hypertension (mean ABPM ≥130/80mmHg) will continue with the addition of amlodipine (C) 10mg od. At wk 16, pts achieving BP control will continue in either monotherapy (E), (V) or dual therapy (E+C), (V+C). However, in pts not achieving ABPM target, a third drug, will be added \[indapamide (D) 1.25 mg od\]. All groups at both arms will be evaluated at 24 wks by ABPM.

Eplerenone (-based therapy) arm

Obese pts with hypertension, starting treatment with irbesartan 150mg once daily (OD). ABPM wil be scheduled at wks 8, 16 and 24.

At wk 8 if mean ABPM \< 130/80mm Hg will continue to monotherapy with irbesartan. If not controlled (mean ABPM \> 130/80mm Hg) at wk8, amlodipine 5mg OD will be added.

At wk 16 if mean ABPM \< 130/80mm Hg will continue to monotherapy with irbesartan, or dual therapy with irbesartan and amlodipine. If not controlled (mean ABPM \> 130/80mm Hg) at wk16, indapamide 1,5mg OD will be added. All patients will be followed up for 24 weeks.

Valsartan (-based therapy) arm

저선량 흉부 CT를 사용하여 폐암 검진 프로그램의 참여도를 측정하는 연구입니다.

Low dose CT scans will be performed for three years

Low Dose chest CT Scan for Lung Cancer Screening

폐암 검진을 위한 저선량 흉부 CT 촬영

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

프랑스 오트랭 주에서 저선량 흉부 CT를 이용한 폐암 검진 준수율.

Open label, single arm treatment with bbT369

bbT369 is a genetically modified autologous T cell immunotherapy product consisting of T cells that are transduced with a single lentiviral vector (LVV) to express anti-CD79a and anti-CD20 chimeric antigen receptors (CARs) and transfected with an mRNA encoding the CBLB-targeting megaTAL enzyme to edit the CBLB gene, suspended in a cryopreservative solution.

bbT369

AMX0035 administered by mouth for 208 weeks: Once daily for first 3 weeks and then twice daily for the remainder of the study if tolerated by participant

AMX0035

Participants received LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks

CS0159

Participants will receive 7.40 MBq (200 μCi) ±10% of TRC003 by intravenous infusion every 8 weeks (±1 week) for a maximum of 6 cycles if participants benefit from the treatment.

TRC003 is a radioligand therapeutic agent indicated for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. TRC003 is a 225Ac-labeled novel molecule for targeted alpha therapy (TAT), which delivers alpha-particle radiation specifically to prostate cancer cells expressing PSMA. Inside the body, it attaches itself to PSMA on the cell surface of the prostate cancer cells and emits radiation to kill them.

Radiopharmaceuticals

Participants will receive 9.25 MBq (250 μCi) ±10% of TRC003 by intravenous infusion every 8 weeks (±1 week) for a maximum of 6 cycles if participants benefit from the treatment.

Participants will receive 11.10 MBq (300 μCi) ±10% of TRC003 by intravenous infusion every 8 weeks (±1 week) for a maximum of 6 cycles if participants benefit from the treatment.

Sujun Han, MD, PhD

Nianzeng Xing, MD, PhD

Ying Shen, MD, PhD

Dingwei Ye, MD, PhD

게푸룰리맙을 사용하는 소아 중증 근무력증 환자에게 약물의 체내 작용과 효과를 살펴보는 시험입니다.

On Day 1, participants will receive a weight based loading dose followed by a weekly maintenance dose for up to 122 weeks.

Combination product consisting of syringe prefilled with gefurulimab will be administered weekly via subcutaneous (SC) injection.

Gefurulimab

Administered by intravenous (IV) infusion

REGN5459

Sequential, open-label, 10-day or 14-day fixed-dose cohorts.

Atumelnant is an orally active investigational agent which antagonizes the action of ACTH at its receptor administered as oral tablets.

세쿠키누맙

ZYN002 - 경피 젤, 위약

ELX/TEZ/IVA, 부가가치세

RVP-001

말기 색소성 망막염 환자를 대상으로 한 KIO-301의 유리체강내 주사 2상 임상 연구

ELX/TEZ/IVA, 부가가치세

발스틸리맙, 생체 시료 수집, 보텐실리맙, 컴퓨터 단층 촬영, 레고라페닙

금 나노결정

XXB750 약물, 위약

LTP001, 위약

에플레레논(-기반 치료)군, 발사르탄(-기반 치료)군

프랑스 오트랭 주에서 저선량 흉부 CT를 이용한 폐암 검진 준수율.

bbT369

AMX0035

LTP001

CS0159

방사성 의약품

게푸룰리맙

REGN5459

아투멜난트