CTRI/2025/03/081845已完成3 期
A multicenter, randomized, double blind, placebo-controlled, three-arm, prospective, Phase 3 study to evaluate the efficacy, safety, and tolerability of IMP1 and IMP2, potentized formulations, in the treatment of patients with Hypothyroidism.
Biosimilia Pvt. Ltd3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Change in serum level of TSH at the end of the 16 weeks treatment period with respect to its baseline.
研究概览
简要总结
This is a multicenter, randomized, double blind, placebo-controlled, three-arm, prospective, Phase 3 study to evaluate the efficacy, safety, and tolerability of IMP1 and IMP2, potentized formulations, in the treatment of patients with Hypothyroidism.Efficacy will be evaluated by measurement of the Change in the Serum level of TSH, Free T3, Free T4, and Anti-TPOAb levels.Adverse events (AEs) and SAEs will be collected throughout the study. The assessment of the tolerability of study drug will be based on incidence of AEs and SAEs and global tolerability assessment. The design for this study is developed based upon the findings of the preclinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 13.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Provision of signed and dated informed consent form.
- •Participants who are diagnosed with hypothyroidism, but not on any medicinal treatment for the same.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Participants must have a BMI between 18.5 Kg per m2 to 30.0 Kg per m2 (inclusive) at Screening Visit.
- •Serum TSH at screening between 5.0 µIU per ml to10.0 µIU per ml.
- •Ability to take oral medication and be willing to adhere to the study intervention regimen.
- •For females of reproductive potential: use of highly effective contraception during study participation and for an additional 1 Month after the end of study intervention administration.
- •For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
- •Agreement to adhere to Lifestyle Considerations throughout study duration.
排除标准
- •Participants suffering from congenital hypothyroidism.
- •Serum TSH at Screening less than 5.0 µIU per ml or above 10.0 µIU per ml.
- •Participants already undergoing Levothyroxine sodium therapy for hypothyroidism.
- •Known cases of secondary hypothyroidism.
- •Abnormal ECG results thought to be potentially clinically significant according to the Investigator or designee, or QT prolongation (QTcF more than equal to 450 msec for male participants or more than equal to 470 msec for female participants) at the Screening Visit.
- •Clinically significant results according to the Investigator or designee, on physical examination, medical history, ECG, hematology, clinical chemistry that may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant’s participation in the study.
- •Sitting systolic BP [more than equal to 140 mm Hg or less than equal to 90 mm Hg] or sitting diastolic BP [more than equal to 90 mm Hg or less than equal to 50 mm Hg] at the Screening Visit.
- •(Untreated cases of hypertension.)
- •Pregnant (positive urine pregnancy test at screening or baseline visits) or breast feeding participants or subject planning a pregnancy in the next months.
- •Known allergic reactions or hypersensitivity to components of the study intervention.
- •Treatment with another investigational drug or other intervention within 3 months.
- •Reports smoking of more than 10 cigarettes per day, use of more than 4 packets per day of tobacco products or use of nicotine products (patches, gums, etc.) corresponding to more than 10 cigarettes per day or who are unable to abstain from smoking during the participation in the study.
- •Cancer pathology, active or in remission for less than 5 years.
- •History of alcoholism, drug abuse (within the previous 5 years) or severe psychiatric diseases that could invalidate the informed consent or limit the participant compliance with protocol requirements.
- •Presence of any medical condition or other circumstances which would significantly affect the safety of the participant or decrease the chance of obtaining reliable data, achieving study objectives or completing the study
- •The participant has a concurrent disease, condition, or is in a situation which, in the Investigator’s opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant’s participation in the study.
- •Directly or indirectly involved in the conduct and administration of this study as an Investigator, sub-investigator, study coordinator, or other study staff member; or employee of the Sponsor or a first-degree family member, significant other, or relative residing with one of the above persons involved directly or indirectly in the study; or enrolled in the study at another clinical site.
结局指标
主要结局
Change in serum level of TSH at the end of the 16 weeks treatment period with respect to its baseline.
时间窗: End of the 16 weeks
次要结局
- Change in serum level of TSH at the end of the 8 weeks treatment period with respect to its baseline.(End of the 8 weeks)
- Change in serum level of free T3 and free T4 at the end of the 8 and or 16 weeks treatment period with respect to its baseline.(End of the 8 and or 16 weeks)
- Change in Zulewski’s clinical scoring for hypothyroidism from baseline to end of the study.(End of the 16 weeks)
- Change in Health-related quality of life (HRQoL) Short Form Health Survey (SF36) from baseline to end of the study.(End of the 16 weeks)
- The proportion of study participants reporting incidences of AE and/or SAE during the study and their assessment with respect to intensity, duration, pattern, and causal relationship to the study medication.(Day 1, 8 weeks and 16 weeks)
- Changes in Laboratory Safety Parameters (Hematology, and Serum Biochemistry analysis) from baseline to end of the study.(End of the 16 weeks)
- Changes in Vital Signs from baseline to end of the study.(End of the 16 weeks)
- Change in body weight from baseline to end of the study.(End of the 16 weeks)
- Global tolerability assessment by patients and investigators at the end of the treatment on a 3-point scale ranging from “good tolerability (side effects may be mild or not observed)” to “poor tolerability (side effects severe or warranting/needing discontinuation)”.(End of the 16 weeks)
- Percent Change from Baseline Mean in Anti TPOAb Levels.(End of the 16 weeks)
研究者
Mr Sachin Pawar
CLINICA Research Solutions LLP
研究点 (3)
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