A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease

Conditions

Grave’s Disease

Brief summary

Proportion of participants who are euthyroid and off ATD at Week 26

Detailed description

Proportion of participants who are euthyroid and off ATD at Week 52, Proportion of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 52, Proportion of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 52 to Week 78, Proportion of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 52 to Week 104, Proportion of participants who have a TRAb value at Week 25 and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 26 to Week 52, Proportion of participants who have a TRAb value at Week 25 and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 26 to Week 78, Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline, Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline, Proportion of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 26, Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 26, Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 52

Related papers

No related papers found yet.

Interventions

DRUGIMVT-1402

DRUGPlacebo is identical to IMP but with no active substance.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of participants who are euthyroid and off ATD at Week 26	—

Secondary

Measure	Time frame
Proportion of participants who are euthyroid and off ATD at Week 52, Proportion of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 52, Proportion of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 52 to Week 78, Proportion of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 52 to Week 104, Proportion of participants who have a TRAb value at Week 25 and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 26 to Week 52, Proportion of participants who have a TRAb value at Week 25 and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 26 to Week 78, Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at ba	—

Measure

Time frame

Proportion of participants who are euthyroid and off ATD at Week 52, Proportion of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 52, Proportion of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 52 to Week 78, Proportion of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 52 to Week 104, Proportion of participants who have a TRAb value at Week 25 and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 26 to Week 52, Proportion of participants who have a TRAb value at Week 25 and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 26 to Week 78, Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at ba

—

Countries

Belgium, Germany, Hungary, Italy, Poland, Spain

Outcome results

None listed