Phase 2 Study to Assess Efficacy & Safety of WP1302 Prevent Relapse of MMI w/Draw in Subj. w/ Graves' dz
- Conditions
- Graves Disease
- Registration Number
- NCT06240455
- Lead Sponsor
- Worg Biotherapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 176
Inclusion Criteria:<br><br> 1. Age 18 to 65 years at the time of informed consent.<br><br> 2. Confirmed diagnosis of Graves' disease through medical history and/or physical<br> examination, laboratory evidence as documented by a serum TSH<0.5 mU/L and either<br> a serum total T3 >180 ng/dL or a serum free T4 > 1.8 ng/dL.<br><br> 3. Current use of MMI at stable dose not exceeding 20 mg daily for at least 8 weeks and<br> no more than 24 weeks by the baseline (Week 0).<br><br> 4. 60 ng/dL < serum total T3 = 180 ng/dL, 0.8 ng/dL < serum free T4 =1.8 ng/dL,<br> and 0.5 mU/L = serum TSH <5 mU/L at the Screening Visit.<br><br> 5. Willing and able to give written informed consent, agree to provide contact with the<br> endocrinologist (or other appropriate trained healthcare provider), and to comply<br> with protocol assessments/procedures.<br><br> 6. Male subjects must be sterile (biologically or surgically) or commit to the use of a<br> reliable method of birth control for the duration of the study, and until at least 6<br> months after the last dose of WP1302.<br><br>Female subjects of child-bearing potential must use a highly effective method of<br>contraception throughout the entire duration of the study and for at least 6 months after<br>the last dose of WP1302.<br><br>Exclusion Criteria:<br><br> 1. Currently using biotin supplements.<br><br> 2. Known history of allergy to the ingredients of WP1302, or hypersensitivity reaction<br> that in the opinion of the investigator would exclude the subject's participation in<br> the study.<br><br> 3. Previous treatment with radioiodine or (partial or complete) thyroidectomy.<br><br> 4. Subjects with known pituitary disease, such as traumatic brain disease,<br> hyperprolactinemia, and hypophysitis.<br><br> 5. Treatment with steroids (administered via the oral and/or parenteral routes) within<br> 3 months prior to baseline or requiring intermittent use of systemic steroids for<br> disease management (such as severe asthma), inhaled steroids are not prohibited.<br><br> 6. History of hyperthyroidism not caused by Graves' disease (e.g., toxic multinodular<br> goiter, autonomous thyroid nodule, or acute inflammatory thyroiditis).<br><br> 7. Subjects who may have thyroid nodules that require alternative intervention.<br><br> 8. Symptoms and signs of thyroid storm such as fever, profuse sweating, vomiting,<br> diarrhea, delirium, severe weakness, seizures, markedly irregular heartbeat, yellow<br> skin and eyes (jaundice), severe low blood pressure, and coma, pyrexia with no other<br> cause than hyperthyroidism.<br><br> 9. Subjects who have a history of intolerance or contraindication to the use of<br> beta-blockers.<br><br> 10. Subjects with history of arrhythmia, or cardiovascular accident, or other<br> cardiovascular disease who maybe at increased risk of cardiac adverse events from<br> treatment or recurrence of hyperthyroidism.<br><br> 11. Subjects with history of cerebrovascular accident/transient ischemic attack, or<br> other cerebrovascular disease who maybe at increased risk of neurologic adverse<br> events from treatment or recurrence of hyperthyroidism.<br><br> 12. Prior treatment with immunotherapies (including rituximab), any cytokine or<br> anti-cytokine therapy.<br><br> 13. Prior treatment with immunomodulatory drugs, such as cyclosporine A, methotrexate,<br> and/or cyclophosphamide.<br><br> 14. Prior use of disease-related T cell-inducing therapy or peptide-tolerizing agent to<br> treat Graves' disease.<br><br> 15. Inadequate liver function, defined by a total bilirubin, aspartate aminotransferase<br> (AST), alanine aminotransferase (ALT) or alkaline phosphatase > 3 times the upper<br> limits of the normal (ULN) at screening.<br><br> 16. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2, calculated as<br> individual eGFR derived from Modification of Diet in Renal Disease formula.<br><br> 17. Receiving hemodialysis or peritoneal dialysis or microdialysis or continuous<br> venovenous hemofiltration or continuous venovenous hemodialysis.<br><br> 18. History of malignancy of any organ system (other than localized basal cell carcinoma<br> of the skin), treated or untreated, within the past 5 years, regardless of whether<br> there is evidence of local recurrence or metastases.<br><br> 19. Known history of active or chronic infectious disease or any disease which<br> compromises immune function (e.g., HIV+, HTLV-1, active Lyme disease, latent or<br> active TB, viral hepatitis).<br><br> 20. Major surgery within 6 months prior to the screening visit or requiring ongoing<br> active treatment after surgery irrespective of the time since surgery.<br><br> 21. Active thyroid eye disease (clinical activity score [CAS] =3) with functional visual<br> impairment sufficient to cause poor quality of life, or dysthyroid optic neuropathy<br> likely to require immunosuppressive treatment during the 30 weeks of the study.<br><br> 22. Any vaccination within 30 days prior to screening, except for influenza and<br> coronavirus vaccines.<br><br> 23. Being pregnant, breastfeeding, or planning to become pregnant during the study.<br><br> 24. Documented presence of immunodeficiency or an immunocompromised condition including<br> hematologic malignancy, bone marrow transplant, or known human immunodeficiency<br> virus infection with a CD4 count <200/mm3.<br><br> 25. Currently actively moderate-heavy using tobacco (=10 cigarettes a day).<br><br> 26. Participating in any clinical study of any investigational medication (i.e.,<br> unauthorized medication) within 90 days prior to randomization.<br><br> 27. Any other significant medical illness or psychiatric conditions that in the opinion<br> of the investigator, would preclude participation in the study or impair the ability<br> to give informed consent; any other clinically apparent autoimmune disease currently<br> requiring disease-modifying or anti-inflammatory treatment; or significant illness<br> which has not resolved within 4 weeks prior to the planned date of first dose of<br> WP1302.<br><br> 28. Any other conditions or prior therapies, which, in the opinion of the investigator,<br> would make the subject unsuitable for this study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse rate
- Secondary Outcome Measures
Name Time Method Replase time;Number of participants with treatment-related adverse events as assessed by CTCAE v5.0;Total T3, free T4, and TSH levels;Pharmacokinetics (PK) parameters (AUC, Cmax);Incidence of anti-drug antibodies (ADAs)